A Pilot Study to Promote Abstinence from Nicotine: The Effects of the End Nicotine Dependence Program

Cigarette smoking is the leading cause of preventable death in the U.S. Cigarette smoking primarily starts in adolescence. Among detained juvenile offenders, 82.1% had smoked cigarettes prior to their incarceration. None of the six juvenile justice services (JJS) facilities located in Utah offer a stop-smoking program. Detained juveniles have more health disparities, lower socioeconomic status, and inconsistent access to health care than the non-detained population. The purpose of this project was to implement an evidence-based program promoting abstinence from nicotine products. Nine participants (n=9) were recruited within the JJS facilities. Pre- and post-questionnaires were administered to obtain demographic and examine the change regarding intent to quit smoking. Feasibility and adaptability questionnaires were administered to the staff participants to determine the need for a stop-smoking program at the facility and to identify potential barriers. Most of the participants identified as Hispanic/Latino. The project resulted in a positive change in intent, with a total of 43% of the participants reporting an increase in their intent to quit smoking. Based on the feasibility and adaptability questionnaire, 100% of the staff participants and stakeholders felt that the END program would be useful and helpful in their facility. However, a total of 25% of the staff participants agreed to adapt their workflow and support the END program. The prevalence among incarcerated youths is high, especially among younger adolescents and minority groups. The END program has great potential for reducing smoking prevalence among incarcerated adolescents.

Running head: A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE A Pilot Study to Promote Abstinence from Nicotine: The Effects of the End Nicotine Dependence Program Dallas Bowles Project Chair: Larry Garrett Content Experts: Jennifer Clifton University of Utah In partial fulfillment of the requirement for the Doctor of Nursing Practice 1 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 2 Table of Contents Abstract .......................................................................................... Error! Bookmark not defined. Introduction ............................................................................................................................... 5 Problem Description ........................................................................................................... 5 Available Knowledge.......................................................................................................... 5 Health Disparities................................................................................................................ 7 Cultural and Environmental Factors ................................................................................... 8 Marketing Strategies and Novel Products........................................................................... 9 End Nicotine Dependency (END) Program ...................................................................... 10 Local Barriers.................................................................................................................... 11 Rationale ........................................................................................................................... 12 Specific Aims .................................................................................................................... 13 Intended Improvement ...................................................................................................... 14 Methods................................................................................................................................... 14 Introduction ....................................................................................................................... 14 Context .............................................................................................................................. 14 Interventions ..................................................................................................................... 15 Measures ........................................................................................................................... 16 Analysis................................................................................................................................... 17 Ethics....................................................................................................................................... 18 Results ..................................................................................................................................... 19 Phase I ............................................................................................................................... 19 Phase II.............................................................................................................................. 20 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 3 Phase III ............................................................................................................................ 21 Phase IV ............................................................................................................................ 21 Discussion ............................................................................................................................... 22 Strengths ........................................................................................................................... 23 Limitations ........................................................................................................................ 23 Conclusions ....................................................................................................................... 24 References ..................................................................................................................................... 25 Appendix A: Phone Questionnaire of JJS..................................................................................... 32 Appendix B: Study Outline........................................................................................................... 33 Appendix C: Pre-Questionnaire .................................................................................................... 34 Appendix D: Post-Questionnaire .................................................................................................. 39 Appendix E: Feasibility and Adoptability Questionnaire ............................................................. 43 Appendix F: Providers and Stakeholders PPT.............................................................................. 44 Appendix G: Utah DHS IRB ........................................................................................................ 47 Appendix H: Utah DHS IRB Continued ...................................................................................... 48 Appendix I: University of Utah IRB............................................................................................. 49 Appendix J: Demographics ........................................................................................................... 50 Appendix K: Tobacco Use ............................................................................................................ 51 Appendix L: Change of Intent ...................................................................................................... 52 Appendix M: Staff and Provider Questionnaire ........................................................................... 53 Appendix N: Desire to Quit Smoking........................................................................................... 55 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 4 Abstract Cigarette smoking is the leading cause of preventable death in the U.S. Cigarette smoking primarily starts in adolescence. Among detained juvenile offenders, 82.1% had smoked cigarettes prior to their incarceration. None of the six juvenile justice services (JJS) facilities located in Utah offer a stop-smoking program. Detained juveniles have more health disparities, lower socioeconomic status, and inconsistent access to health care than the non-detained population. The purpose of this project was to implement an evidence-based program promoting abstinence from nicotine products. Nine participants (n=9) were recruited within the JJS facilities. Pre- and post-questionnaires were administered to obtain demographic and examine the change regarding intent to quit smoking. Feasibility and adaptability questionnaires were administered to the staff participants to determine the need for a stop-smoking program at the facility and to identify potential barriers. Most of the participants identified as Hispanic/Latino. The project resulted in a positive change in intent, with a total of 43% of the participants reporting an increase in their intent to quit smoking. Based on the feasibility and adaptability questionnaire, 100% of the staff participants and stakeholders felt that the END program would be useful and helpful in their facility. However, a total of 25% of the staff participants agreed to adapt their workflow and support the END program. The prevalence among incarcerated youths is high, especially among younger adolescents and minority groups. The END program has great potential for reducing smoking prevalence among incarcerated adolescents. Keywords: adolescent, tobacco, vape, stop-smoking program, smoking cessation. A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 5 Introduction Problem Description According to the National Institute on Drug Abuse (2014), the juvenile justice system presents an opportunity to facilitate treatment of substance use disorders. Nicotine use among the incarcerated youth population appears to be at an epidemic level. Among juvenile offenders, 82.1% smoked cigarettes prior to their incarceration (Haysom et al., 2017). Given this high rate of nicotine use among the incarcerated youth population, the juvenile justice system is an excellent setting in which to implement nicotine prevention and cessation programs. Through observation and a phone questionnaire conducted during 2017 (see Appendix A), it was determined that none of the six juvenile justice facilities located in Utah offer an adolescent smoking cession program. This suggests that both prevention and treatment services for nicotine use disorders are limited in juvenile secure facilities, despite a firmly established alliance between healthcare services and juvenile justice centers. Available Knowledge Due to health disparities, problematic behaviors, and environmental factors, the incarcerated juvenile population may have a greater burden of risk factors and/or may experience risk factors starting at an earlier age as compared to the general youth population. This may increase their rates of early nicotine use. Early onset of nicotine use increases the chances that a person will become addicted to nicotine, compared to individuals who start smoking at a later stage in life (U.S. Department of Health and Human Services [USDHHS], 2012). The use of nicotine products during youth increases the risk for health problems and lifelong nicotine addiction. A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 6 A study by Ramaswamy et al. (2013) showed that adolescents' smoking rates were 62.9% prior to incarceration and 69% one year after release from custody. Psychological stress associated with incarceration may increase the juvenile's desire to use nicotine (Howell, Guydish, Kral, & Comfort, 2015). This may also be due to the ban on smoking within juvenile justice facilities. Howell et al. identified the presence of a pre-incarceration smoking habit and life disturbances prior to incarceration as factors correlated with participants' psychological distress. The odds of smoking increased with length of incarceration, possibly due to socialization or increased levels of stress in custodial environments (Howell et al., 2015). Incarcerated juvenile offenders have disproportionately elevated health disparities (Barnert, Perry, & Morris, 2016). These include problematic behaviors associated with untreated mental health disorders. According to the National Center for Mental Health and Juvenile Justice (n.d.), the prevalence of co-occurring mental health and substance use disorders affect up to 5075% of youth in the juvenile justice system. Environmental factors, juvenile justice system challenges and culture, and marketing aimed at youth-including the use of novel products- contribute to the high rates of nicotine use among this population. The use of tobacco by youth remains a serious problem and is unsafe in any form (Centers for Disease Control and Prevention [CDC], 2018). Nicotine use primarily starts in adolescence. Nine out of 10 cigarette smokers first tried smoking by the age of 18 (USDHHS, 1994; USDHHS, 2012; USDHHS, 2014). The rate of e-cigarette use among Utah students tripled from 2011 to 2013. In 2013, 8% of 12th-graders reported using e-cigarettes in the past month (Utah Department of Health [UDH], 2016). National estimates suggest that, each day, more than 3,200 individuals under the age of 19 smoke their first cigarette, with an additional 2,100 youth and young adults becoming regular cigarette smokers (CDC, 2017). An estimated 60-85% of A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 7 youth nicotine users have made at least one failed attempt to quit (Jamal, Dube, Babb, & Malarcher, 2014). Additionally, in 2014, almost three-quarters of high school students (73%) and over half of middle school students (56%) who reported using tobacco products in the past 30 days used a flavored product (CDC, 2016). Although cigarette smoking has decreased among high school and middle school students in recent years, the use of other novel tobacco products (e.g., ecigarettes, hookahs, and smokeless tobacco) has increased (CDC, 2016). Empirical research does not substantiate claims that such tobacco products are healthier alternatives to cigarettes (UDH, 2016). The average rate of youth smokers across the United States is 15.7%; in 2013, the smoking rate among Utah students in ninth through 12th grades was 4.4% (Environmental Public Health Tracking, 2016). Health Disparities Incarcerated juveniles are more likely than the general youth population to experience health disparities, lower socioeconomic status, and inconsistent access to health care (Cork, 2012). For many youth, confinement in the juvenile justice system is the first time they have consistent access to healthcare services. An alliance already exists between State health services and the juvenile justice system. Dental services, vocational rehabilitation, general medical needs, psychotherapy, and trauma counseling are all available in Utah detention centers. For substance abuse programs, therapists use Seeking Safety, ADAPT, and trauma-based modalities. Although broad treatment options are available for the incarcerated juvenile population, the healthcare offered often does not feature the multi-layered and integrated services the population requires (Henderson et al., 2007). The period during which a juvenile offender is still young, has access to healthcare services, and is under the care of the State is the perfect time to offer prevention and A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 8 control for nicotine use. Of all young people who become new smokers each year, almost a third will ultimately die of a tobacco-related disease (Cork, 2012). Cigarette use and exposure to secondhand smoke results in approximately 500,000 premature deaths per year in the U.S., as well as $96 billion in healthcare costs and an additional $97 billion in lost productivity per year (Cork, 2012). Other health disparities such as mental health diagnoses (Tobacco Control Legal Consortium, 2012; Cropsey, Linker & Waite, 2008), especially of ADHD (Stanton & Grimshaw, 2013), and the presence of other substance use disorders significantly increase the risk for nicotine use. Teens with comorbid anxiety and depression are more likely to experiment with tobacco (USDHHS, 1994). Youth who engage in unhealthy behaviors, including substance use (e.g., cannabis, alcohol, and other drugs) have a higher risk of nicotine use (Cropsey et al., 2008; Duhig, Cavallo, McKee, George, & Krishnan-Sarin, 2005; Puljević, Kinner, & de Andrade, 2017; Ramaswamy et al., 2013). In the absence of a fully-functional prefrontal cortex and with a still-immature limbic system, youths may not understand the full consequences of nicotine and the harmful effects of smokeless products which may impact self-control, decision making, emotions, and risk-taking behaviors (Arain et al., 2013). Imaging studies revealed that myelinogenesis continues from puberty up to age 24. During adolescence, the brain also experiences a surge of myelin synthesis in the frontal lobe, which is implicated in cognitive processes (Arain et al., 2013). The surge in neurogenesis effects behavioral processes including self-control, decision making, emotions, and risk-taking behaviors (Arain et al., 2013). Cultural and Environmental Factors Major environmental factors, such as absences in school or truancy (Henderson et al., 2007; Ramaswamy et al., 2013), are highly correlated with nicotine use. On average, high-risk A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE youths live in environments where family and friends use nicotine, and such use is considered a social norm (Cropsey et al., 2008; Cork, 2012). The use of e-cigarettes has increased among middle and high school students, and about four million students in the United States currently use two or more tobacco products (CDC, 2017). Another environmental factor that is associated with nicotine use is a history of foster care or living with one parent (Cropsey et al., 2008; Ramaswamy et al., 2013). Marketing Strategies and Novel Products According to a report on the consumption of cigarettes and combustible tobacco in the United States in 2000-2011, traditional smoking of tobacco has decreased over the past decade (CDC, 2012a). The Federal Public Health Cigarette Smoking Act of 1969 prohibited the marketing of nicotine on television and radio broadcasting (CDC, 2012a). Despite this restriction, there is increasing concern about marketing strategies for flavored tobacco products, which are enticing to youth (U.S. Food and Drug Administration, 2017). The Family Smoking Prevention and Tobacco Control Act of 2009 prohibits branding flavors (e.g., fruit, chocolate, and other sweet flavors) of traditional cigarettes; however, the act does not prohibit branding flavors of alternative tobacco products or smokeless tobacco (Delnevo, Giovenco, Ambrose, Corey, & Conway, 2015). The growth of alternative tobacco products and the sale of flavored nicotine may have contributed to the increase in youth nicotine consumption (Delnevo et al., 2015; Singh, et al., 2016; U.S. Government Publishing Office, 2009). The use of alternative tobacco products, such as e-cigarettes, vapors, and other electronic nicotine delivery systems (ENDS) has become a growing trend among adults and adolescents over the past decade. One of the most common devices is the e-cigarette, which includes a tank to hold liquid containing nicotine (also referred to as e-juice) and other chemicals turned into 9 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 10 vapor. E-juice can contain 0-20 milligrams of nicotine (Lippi et al., 2014), and although some ENDS do not contain any nicotine, a survey showed that 97% of respondents used ENDS that did contain nicotine (Brandon et al., 2015). Flavored tobacco products can be more enticing to youth because they lack the pungent smell and taste of traditional tobacco products. Further, skilled smokers may learn how to use e-cigarettes in a way that increases their exposure to nicotine by adjusting voltages to deliver a higher concentration of nicotine than traditional cigarettes (American Lung Association [ALA], 2016). Youth are increasingly using e-cigarettes and other cigarette alternatives that contain tobacco and nicotine for a variety of reasons including: the increasing number of state and local smoke-free policies, cigarette alternatives being in vogue, emerging social norms discouraging smoking cigarettes, and alternative products being marketed as safer than traditional cigarettes (Utah Department of Health, 2013). Additionally, most e-juices still contain nicotine, despite the claims of manufacturers that some e-juices do not (ALA, 2016). The claims about new nicotine and tobacco products being safer than traditional cigarettes are unsubstantiated, and products such as e-cigarettes and smokeless tobacco may serve as gateways to smoking combustible cigarettes (Utah Department of Health, 2013). End Nicotine Dependency (END) Program The End Nicotine Dependency (END) program was designed by the Utah Department of Health for use in several different settings, including communities, schools, and incarceration facilities (UDH, 2004). Currently, no juvenile justice services (JJS) facility in Utah utilizes the END program. By implementing the END program within the juvenile justice system, the intention of this project was to address the current lack of standardized tobacco cessation, policy implementation, and prevention strategies, and potentially influence teen smoking cessation on A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 11 individual, interpersonal, community, organizational, and policy levels. This project evaluated the effectiveness of the END program and was piloted at one of the JJS locations in Salt Lake City. Piloting an evidence-based nicotine prevention and control program in a juvenile justice center was expected to reduce nicotine consumption within the pilot group. Other replications of the END program in similar settings resulted in 61% of program participants quitting or reducing their tobacco use (UDH, 2004). While there were no control groups available for the END program, a meta-analysis of other teen cessation programs found a mean tobacco quit rate of 7% in adolescent control groups: about half the 13% quit rate among END participants (UDH, 2004). The END program is designed especially for youth. The program builds on skills and knowledge related to nicotine use, including social skills, communication building, stress management, decision-making skills, goal setting, nutrition management, and exercise (UDH, n.d.). Local Barriers System challenges, including length of detainment, complicate the establishment of stopsmoking programs. Established treatment programs frequently fail to prioritize nicotine use disorders, and correctional facility administrators have historically designated smoking cessation programs as low priority compared to other healthcare issues (Donahue, 2009). Further, there are worries that nicotine cessation efforts will diminish overall sobriety from other substances (Baca & Yahne, 2009). The assessment of all substance use disorders, including nicotine substances, at the pilot facility involved five questions regarding: date range of use, products tried, habit developed, last use, and comments about use. This clinical assessment of substance use is limited in nature and misses several key features, such as the use of multiple tobacco products, family history, and A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 12 social and physical environments that affect use. A more thorough assessment may lead to better interventions for smoking cessation among juveniles. Daily nicotine use increases dramatically from early adolescence into adulthood. Therefore, the findings of this study indicate that a focus on assessment of stop-smoking programs for adolescents and young adults may have a significant impact on the reduction of nicotine use. Facility and client barriers may prevent treatment for nicotine use among incarcerated juveniles. The primary barrier at the site of this study was an absence of protocol. Instead of a standardized program, the treatment of tobacco use disorder is at the provider's discretion upon assessment of the patient. The facility has a general drug and alcohol program, but no content specific to tobacco use disorder. Universal juvenile barriers to achieving and maintaining sobriety from nicotine are poor motivation, client resistance, length of placement, and lack of support system (Cork, 2012). All of these barriers were present at the JJS study site. Rationale The process of implementing the END program in the pilot facility is based upon two separate, but related models of change, they are the Social Ecological Model (SEM) and the Transtheoretical Model of Change. The SEM is a theory-based framework that enhances our understanding of multifaceted interactions and influences between various levels of the social system (UNICEF, n.d.). There are five hierarchical levels of SEM: individual, interpersonal, community, organizational, and policy/enabling environments (UNICEF, n.d.). The model illustrates the pathways for a multilevel influence of the target problem (Sorensen, Barbeau, Hunt, & Emmons, 2004). This project employed two central SEM levels: the social system (the group intervention intended to maintain abstinence once juveniles are released from JJS) and the individual level system (which A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 13 addresses issues from an organizational standpoint). Piloting a nicotine cessation program at JJS may facilitate a policy change. Multiple sources have cited the social-cognitive interventions as effective in reducing smoking among youth and suggested that they may influence smoking uptake (Gabble, Babayan, DiSante, & Schwartz, 2015; Patnode et al., 2013; Shackleton et al., 2016). Nevertheless, JJS staff must introduce the interventions at appropriate times-which correspond with the client's readiness to stop using the substance of choice-for them to be effective. The Transtheoretical Model of Change is a form of stage-based therapy including motivational interviewing, which promotes readiness and contributes to clients' advancement to the next stage of the recovery process. This theory emphasizes five stages of change that accurately correlate to the subjects' devotion to and readiness for transformation to take place (Robinson & Vail, 2012). These stages represent overlapping steps in the recovery process, from considering quitting to maintaining behavior that avoids relapse. These stages include: precontemplation, contemplation, preparation, action, and maintenance (Koyun & Eroglu, 2016). Specific Aims This project's purpose was to implement an evidence-based program to promote abstinence or reduced usage of nicotine products among incarcerated adolescents upon release from the juvenile justice system. The ideal is to distribute the project findings to stakeholders and clinicians and to formally integrate the END-based program into clinical practice at additional juvenile justice locations. A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 14 Intended Improvement This project's focus was on piloting the END program to promote abstinence from nicotine among incarcerated youth. It also assessed the history of nicotine use and associated behaviors among incarcerated youth and gathered perceptual data from providers and stakeholders regarding the future implementation of the END program at the identified clinical setting. The goal of piloting this program, was to promote change in current clinical practice regarding the treatment of tobacco use disorders in the Utah juvenile justice system, and to integrate the END-based program into clinical practice at additional locations with a broader patient population. Methods Introduction Nicotine use by juvenile offenders is a complex problem. The juvenile justice system is a large, complicated, and dynamic setting, which houses many troubled youths. The magnitude and complexity of the system make the reduction of nicotine use challenging. However, several juvenile facilities across the United States have fostered various nicotine prevention and control measures and cessation programs (Cork, 2012). Context The study site was a juvenile correctional facility, which is defined by Public Health and Welfare, Title 42 USCS § 5603 (2010) as a setting designed for the purpose of restricting the movement and activities of juveniles in lawful custody for temporary placement while accused of having committed a criminal offense. The site for this project was a juvenile correctional facility in a suburban area, which-at the time of the pilot study-housed approximately 25-30 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 15 male juveniles younger than 20 years of age who were awaiting sentencing, or who had been convicted and were serving a term. The study participants were adolescent males, aged 10-20, who were thinking about using nicotine or who had a history of nicotine use. Participants were required to remain at the identified location throughout the duration of the project and volunteer to participate through an informed consent process. Participants 18 years of age or older were able to consent for themselves; juveniles younger than 18 years of age required the consent of their parents/guardians. The JJS staff members involved were the director of the facility, cottage managers, therapists, full-time psychiatric mental health nurse practitioners, family nurse practitioners, and the Principal Investigator (PI). The PI was a Doctor Nursing Practice (DNP) student specializing in psychiatry and mental health at a local university. The purpose of this quality improvement project was to implement an evidence-based program to promote abstinence from nicotine products among detained adolescents upon release from incarceration through the engagement of a cessation program. Interventions The clinical staff working with the juveniles referred the participants for this study. Staff included a facility director, medical and mental health providers, social workers, and registered nurses. Referrals were obtained from the professionals during weekly staff meetings. The END program pre-treatment questionnaire was then modified and administered on the first day of the group intervention. The data gathered from the questionnaire helped to estimate the onset, duration, and number of previous attempts to stop nicotine use, and assessed initial intent to abstain from nicotine. These data were organized in Excel. A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 16 Precautions were taken to meet the safety needs of the juveniles throughout the implementation phase. For example, incarcerated juveniles are not allowed sharp items such as pencils, glass objects, and scissors. The PI facilitated the eight modules of the END program in a group setting. The intervention process was to educate the juveniles residing at the facility about the END program. The modules were presented bi-weekly for four weeks, in sessions lasting about 45 minutes each. The participants completed END program post-treatment questionnaire at the end of the program to assess the change in the intent to remain nicotine-free once released from custody. The investigator converted project findings into PowerPoint presentation. The final PowerPoint was then delivered to the providers and stakeholders. An anonymous questionnaire was administered during the meeting to providers and stakeholders to obtain feedback on the project. Measures The PI used three measures to assess the effect of nicotine use by incarcerated youth via this pilot program: 1. Completion of the eight END modules; 2. The change of intent pre- and post-intervention as determined through use of a questionnaire; and 3. The feasibility of stakeholders adopting the END program within JJS. These measures are paramount in terms of the likelihood of JJS to adopt the END program within their facilities and change policy. The project chair, director, and content expert approved the eight modules established in the END program outline (see Appendix B). The PI then conducted these modules in a sequence A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 17 over a three-week period. The project chair and content expert also approved pre- and postquestionnaires (see Appendix C). The investigator recruited nine participants and collected nine completed questionnaires. The data was then analyzed from the questionnaires using descriptive statistics to demonstrate the percentage of change to remain nicotine free once released from custody. The feasibility and adaptability questionnaire results were calculated and analyzed using basic statistical analysis to measure the appropriateness of the END program in JJS facilities (see Appendix D) in accordance with the feasibility and adaptability questionnaire. The project chair and content expert reviewed the data for accuracy and completeness. A PowerPoint conveying the results of the project was presented to providers and stakeholders (see Appendix E). The statistical data was analyzed using Excel. Analysis This pilot project included both quantitative and qualitative research designs. The study topic was chosen due to anticipated small sample size and to help determine future feasibility the proposed program within the JJS. Utilization of a four-point Likert Scale allowed for generalization and quantification of facts and patterns of attitudes, behaviors, and opinions retrieved from quantitative section of the pre- and post-questionnaires. Due to the small sample size, the Wilcoxon signed rank test was used to measure the change between pre-intervention and post-intervention scores. To understand the likelihood of the END program's acceptance by stakeholders at that facility and potentially at other JJS facilities employed feasibility and adoptability questionnaires. The data from the questionnaires were analyzed with the help of 5-point Likert Scale. . A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 18 The qualitative section included descriptive analysis, specifically a pre- and postquestionnaire, which permitted better understand of the juveniles' underlying explanations, views, and motivations for nicotine cessation. The pre-questionnaire included three open-ended questions and the post-questionnaire included one open-ended question, which enabled participants to express their opinions. Ethics This project was determined by the University of Utah's Institutional Review Board (IRB) to be a quality improvement study designed to evaluate the effectiveness of the END program. The IRB determined this study to be exempt from human subject review (see Appendix F). The project did not meet the FDA definition of Human Subjects Research, since it did not include a drug, device, or any other article regulated by the FDA. The Utah Department of Human Services (DHS IRB) approved the project on January 24, 2018. The Utah DHS IRB approved the research proposal, informed consent/assent documents, recruitment process, and questionnaires (see Appendix E). No grants, sponsorship, or financial support was received by investigator to conduct this project. The PI provides nursing services to juveniles in programs operated by the Division of Juvenile Justice Services. Concerns about the PI's role and small sample size prompted the modification of the demographic portion of the original END questionnaires. These modifications ensured the privacy and confidentiality of all participants. Potential risks and discomforts to participants as a result of this project included triggers that could cause an increased desire to use nicotine and breach of confidentiality. To minimize that risk associated with increased nicotine cravings, the PI included images and messages with a strong anti-tobacco theme throughout the presentations. Ongoing education A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 19 was provided to participants about the need for confidentiality, the consequences of breaching confidentiality, and that legal privilege would not apply to group discussions. Discussions revolving around issues of confidentiality took place during in the first meeting, and at the beginning of each subsequent module thereafter. Results Phase I The recruitment process took place during the family visiting hours on ten occasions. After acquiring parental/guardian consent for the study, assent from eight juveniles on a single unit was obtained. An 18-year-old participant consented without parental permission. One declined to participate. Demographics. The nine participants completed and returned the pre-questionnaires. All of the END participants were under the age of 18, except for one individual. The majority of END participants identified as Hispanic or Latino (62.5%; n=5), one was Caucasian (12.5%; n=1), one was mixed (Native American or Alaska Native and Black or African American) (12.5%; n=1), and one was Native American or Alaska Native (12.5%; n=1). One participant opted not to identify his race. The average age at the onset of smoking among participants was 12 years (n=8). The onset of tobacco product use ranged from age seven to 15 (n=8). Eighty-six percent of the participants (n=7) reported that they were around other tobacco users at home. Sixty-three percent of the participants (n=8) reported that they were around other tobacco users at work. Quantitative Results from Pre-questionnaires. In regard to tobacco use, 12.5% (n=1) of the participants tried to quit within the last year. None of the participants were preparing to quit smoking within the next 30 days. Before the participants started the END program, they A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 20 reported various forms of tobacco use including cigarettes, cigars, cigarillos, little cigars, tobacco in hookah or water pipe, any form of electronic cigarettes, and chewing tobacco, snuff, or dip (see Appendix K). The results were: • 100% of the END participants (n=9) have smoked cigarettes, even if it is one or two puffs. • 100% of the END participants (n=9) have used any form of electronic cigarettes. • 100% of the END participants (n=9) have used tobacco in a hookah or waterpipe. • 87.5% of the END participants (n=8) have tried cigars, cigarillos, or little cigars. • 50% of the END participants (n=6) have used chewing tobacco, snuff, or dip. Before the delivery of the eight modules, seven participants answered the question revealing their initial intent to quit tobacco products. In response to the question "how much you want to quit smoking cigarettes?" 86% (n=7) of the participants chose "not at all," and 14% (n=7) chose "a little." Qualitative Results from Pre-questionnaires. The qualitative analysis involved evaluations of three written comments that participants provided as the response to the openended questions on each survey. The participants only answered to one of four inquiries given. In response to the question acquiring about reasons and barriers influencing the participants' ability and desire to quit smoking, the participants answered following: (a) "don't want to [quit];" (b) "I don't have a smoking problem;" and (c) "don't smoke." Phase II The PI delivered eight modules over the course of four weeks using the END facilitator manual (see Appendix B); these groups took place in a family style group room with couches forming a circle. One participant changed units prior to the fifth module. Therefore, the sample A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 21 size for post-questionnaires was reduced by one. Three staff members provided security during the intervention phases. Due to safety constrains the flow and supplies used in the activities underwent modifications. The toothpicks, glass jar and coffee straws were omitted by supervising staff. Phase III Quantitative Results from Post-questionnaires. The results of the data gathered from eight post-questionnaires distributed to the project participant reveal the following (see Appendix I): • 43% of participants increased their intent to stop smoking cigarettes. • 29% of participants increased their intent to stop smoking from "not at all" to "a little." • 14% of participants increased their intent to stop smoking from "a little" to "somewhat." It is important to mention that one participant did not complete the question relating to key measure: intent to quit. Qualitative Results from Post-questionnaires. Participants did not provide any qualitative data. Phase IV Presentation and the Feasibility and Adaptability Questionnaire. The information retrieved from the interventions highlighted in phases I to III was analyzed and organized into Power Point presentation for the staff meeting. The four staff participations completed the feasibility and adaptability questionnaire at the end of the meeting. The findings from the feasibility and adaptability questionnaire (see Appendix J) indicate that: A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 22 • 100% of staff participants agreed that the END program is needed at JJS. • 75% of the staff participants agreed that the END program is a reasonable fit for JJS and is helpful. • 100% agreed that nicotine is a big problem among juveniles. • 100% agreed that END program was communicated effectively and gained participation from everyone. • 75% agreed that the END program was sensitive to different cultural needs and concerns. • Only 25% of the staff participants reported that they have the time to implement the END program. • Only 25% of the staff participants agreed to adapt their workflow and support the END program. Discussion In summary, nicotine use is significantly more prevalent among detained adolescents (82.1%) than the general youth population (15.7%) or Utah students in 9th through 12th grades (4.4%; Environmental Public Health Tracking, 2016). Demographically (see Appendix F), most of the participants identified themselves as minorities; the academic level of the participants did not exceed high school education. The onset of nicotine use among participants occurred before the legal smoking age. Abovementioned information is congruent with previous research findings on the subject. All of the END participants used tobacco cigarettes, vapors, and hookah or waterpipe (see Appendix F). In previous research, dual users were identified as using cigarettes and vaping. The dual users were more likely to consume higher amounts of nicotine due to lessened social A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 23 constraints than cigarette users (Robertson et al., 2018). One hundred percent of study participants were "triple users" (identified in the questionnaire as a recurrent user of cigarettes, vapors, and hookah or waterpipe). Triple usage is indicative of a new trend of in-vogue nicotine use and further research is needed to identify potential consequences associated with cooccurrent use of multiple tobacco/nicotine products. By the end of the project, three out of seven (43%) participants reported a change of intent to quit smoking. Based on the results of the confirmatory data analysis, the change was not statistically significant with an alpha of 0.05. There is a high likelihood that statistical significance was not achieved due to the small sample size. Nevertheless, the information driven from youth and staff questionnaires is suggestive of program efficacy. The data from the feasibility and adaptability questionnaires helped to identify potential barriers interfering with further implementation of the END program. Only one of four (25%) staff participants agreed to adapt workflow and support the END program. Based upon previous successful replications, however, there is a high likelihood that implementation of the END program would be successful in the JJS if adequate time and resources were allocated. Furthermore, with ninety percent of the juveniles who were approached agreeing to participate in the program as well as 100% of the staff, indications are high that this program would be successful. Strengths Strengths of the project include the fact that the END program is available at no cost, is easily replicated in different settings, yields a high participation rate (90%) from a single housing unit, and produces a high completion rate (89%). Limitations A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 24 This study's greatest limitation was the small sample size, which was a homogenous population comprising all males. The project was limited to detained juveniles 18 years of age and younger. A large portion of the sample size identified as Hispanic or Latino, which may contribute to presence of cultural bias. The potential countertransference and recall biases of the participants should not be excluded, since the project was not controlled or blinded by design. Additionally, factors that have a potential to have negatively impacted results of this project include disruptive behavior within a group, and the ability of participants to withdraw from this project at any time, with or without cause. Conclusions After piloting the END program, it is clear that the Utah JJS has a high number of juveniles who have tried several different forms of nicotine. Although the results of the project were not statistically significant, the changes in youth intent and the staff's perceived need for a nicotine cessation program warrant support for additional efforts. A second pilot study, conducted on multiple units with a greater sample size and a broader patient population, is needed in order to drive future policy changes. A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 25 References American Lung Association. (2016). E-cigarettes and lung health. Retrieved from http://www.lung.org/stop-smoking/smoking-facts/e-cigarettes-and-lung-health.html Arain, M., Haque, M., Johal, L., Mathur, P., Nel, W., Rais, A., . . . Sharma, S. (2013). Maturation of the adolescent brain. Neuropsychiatric Disease and Treatment, 9, 449-461. http://doi.org/10.2147/NDT.S39776 Baca, C. T., & Yahne, C. E. (2009). Smoking cessation during substance abuse treatment: What you need to know. Journal Substance Abuse Treatment, 36(2), 205-219. Barnert, E. S., Perry, R., & Morris, R. E. (2016). Juvenile incarceration and health. Academic Pediatrics, 16(2), 99-109. Brandon, T. H., Goniewicz, M. L., Hanna, N. H., Hatsukami, D. K., Herbst, R. S., Hobin, J. A., . . . Warren, G. W. (2015). Electronic nicotine delivery systems: A policy statement from the American association for cancer research and the American society of clinical oncology. Clinical Cancer Research, 21(3), 514-525. doi: 10.1158/1078-0432.ccr-142544 Centers for Disease Control and Prevention [CDC]. (2018). Smoking & tobacco use: Youth and tobacco use. Retrieved from https://www.cdc.gov/tobacco/data_statistics/fact_sheets/youth_data/tobacco_use/index. html Consumption of cigarettes and combustible tobacco - United States, 2000-2011. (2012). MMWR Morbidity Mortal Weekly Report, 61(30), 565-569. A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 26 Corey, C., Ambrose, B., Apelberg, B., & King, B. (2015). Flavored tobacco product use among middle and high school students - United States, 2014. MMWR Morbidity and Mortality Weekly Report, 64 (38); 1066-107. Cork, K. (2012). Tobacco and juvenile offenders: Breaking the cycle. St. Paul, MN: Public Health Law Center. Retrieved from www.publichealthlawcenter.org/sites/default/files/resources/phlc-policybriefbreakingthecycle-juvenile-offenders-2012.pdf Cropsey, K. L., Linker, J. A., & Waite, D. E. (2008). An analysis of racial and sex differences for smoking among adolescents in a juvenile correctional center. Drug Alcohol Depend, 92(1-3), 156-163. Delnevo, C. D., Giovenco, D. P., Ambrose, B. K., Corey, C. G., & Conway, K. P. (2015). Preference for flavored cigar brands among youth, young adults and adults in the USA. Tobacco Control, 24(4), 389-394. Donahue, J. J. (2009). Tobacco smoking among incarcerated individuals: A review of the nature of the problem and what is being done in response. Journal of Offender Rehabilitation, 48(7), 589-604. Duhig, A. M., Cavallo, D. A., McKee, S. A., George, T. P., & Krishnan-Sarin, S. (2005). Daily patterns of alcohol, cigarette, and marijuana use in adolescent smokers and nonsmokers. Addictive Behaviors, 30(2), 271-283. Environmental Public Health Tracking. (2016). Complete health indicator report of smoking among adolescents. Retrieved from http://epht.health.utah.gov/ephtview/indicator/complete_profile/CigSmokAdol.html A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 27 Gabble, R., Babayan A., DiSante, E., & Schwartz, R., (2015). Smoking cessation interventions for youth: A review of the literature. Toronto Ontario Tobacco Research Unit. Retrieved from http://otru.org/wp-content/uploads/2015/02/special_youth_cessation.pdf Haysom, L., Lawrence, D., Mellish, D., Burns, P., Khale, P., Arulampalam, A., & Stapylton, C. (2017). Use of nicotine replacement therapy in young people entering custody in New South Wales, Australia. Journal Pediatric Child Health. Henderson, C. E., Young, D. W., Jainchill, N., Hawke, J., Farkas, S., & Davis, R. M. (2007). Program use of effective drug abuse treatment practices for juvenile offenders. Journal of Substance Abuse Treatment, 32(3), 279-290. Howell, B. A., Guydish, J., Kral, A. H., & Comfort, M. (2015). Prevalence and factors associated with smoking tobacco among men recently released from prison in California: A crosssectional study. Addictive Behaviors, 50, 157-160. http://doi.org/10.1016/j.addbeh. 2015.06.017 Jamal, A., Dube, S. R., Babb, S. D., & Malarcher, A. M. (2014). Tobacco use screening and cessation assistance during physician office visits among persons aged 11-21 years - National Ambulatory Medical Care Survey, United States, 2004-2010. MMWR Supplements, 63(2), 71-79. Koyun, A., & Eroglu, K. (2016). The effect of transtheoretical model-based individual counseling, training, and a 6-month follow-up on smoking cessation in adult women: A randomized controlled trial. Turkey Journal Medicine Sciences, 46(1), 105-111. Lippi, G., Favaloro, E. J., Meschi, T., Mattiuzzi, C., Borghi, L., & Cervellin, G. (2014). Ecigarettes and cardiovascular risk: Beyond science and mysticism. Semin Thromb Hemost, 40(1), 60-65. doi:10.1055/s-0033-1363468 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 28 National Center for Mental Health and Juvenile Justice. (n.d.). Providing effective treatment for youth with co-occurring disorders. Retrieved from https://www.ncmhjj.com/wpcontent/uploads/2013/10/Treatment-Brief-FINAL-web1.pdf National Institute on Drug Abuse. (2014). Principles of adolescent substance use disorder treatment: A research-based guide. Retrieved from https://www.drugabuse.gov/ publications/principles-adolescent-substance-use-disorder-treatment-research-basedguide Office of the Law Revision Counsel. (2010). Public Health and Welfare, Title 42 USCS § 5603 Retrieved from http://uscode.house.gov/view.xhtml?path=/prelim@title42/chapter72&edition=prelim Patnode, C. D., O'Connor, E., Whitlock, E. P., Perdue, L. A., Soh, C., & Hollis, J. (2013). Primary care-relevant interventions for tobacco use prevention and cessation in children and adolescents: A systematic evidence review for the U.S. Preventive Services Task Force. Annals of Internal Medicine, 158(4), 253-260. doi:10.7326/0003-4819-158-4201302190-00580 Public Health and Welfare, Title 42 USCS § 5603 (2010). Retrieved from http://uscode.house.gov/view.xhtml?path=/prelim@title42/chapter72&edition=prelim Public Health Law Center. (2012a). Tobacco and juvenile offenders: Breaking the cycle. St. Paul, MN: Cork, K. Public Health Law Center. (2012b). Tobacco in juvenile justice facilities: A policy overview. Retrieved from http://www.publichealthlawcenter.org/sites/default/files/resources/tclc-fsjuvenile-facilities-2012.pdf A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 29 Puljević, C., Kinner, S. A., & de Andrade, D. (2017). Extending smoking abstinence after release from smoke-free prisons: Protocol for a randomized controlled trial. Health & Justice, 5, 1. Ramaswamy, M., Faseru, B., Cropsey, K. L., Jones, M., Deculus, K., & Freudenberg, N. (2013). Factors associated with smoking among adolescent males prior to incarceration and after release from jail: A longitudinal study. Substance Abuse Treatment Prevention Policy, 8, 37. Robinson, L. M., & Vail, S. R. (2012). An integrative review of adolescent smoking cessation using the Transtheoretical Model of Change. Journal of Pediatric Healthcare, 26(5), 336-345. doi: 10.1016/j.pedhc.2010.12.001 Shackleton, N., Jamal, F., Viner, R. M., Dickson, K., Patton, G., & Bonell, C. (2016). Schoolbased interventions going beyond health education to promote adolescent health: Systematic review of reviews. Journal of Adolescent Health, 58(4), 382-396. doi: 10.1016/j.jadohealth.2015.12.017 Singh, T., Arrazola, R. A., Corey, C. G., Husten, C. G., Neff, L. J., Homa, D. M., & King, B. A. (2016). Tobacco use among middle and high school students - United States, 2011-2015. MMWR, 65(14), 361-367. Sorensen, G., Barbeau, E., Hunt, M. K., & Emmons, K. (2004). Reducing Social Disparities in Tobacco Use: A Social-Contextual Model for Reducing Tobacco Use Among BlueCollar Workers. American Journal of Public Health, 94(2), 230-239. Stanton, A., & Grimshaw, G. (2013). Tobacco cessation interventions for young people. Cochrane Database System Review, (8). A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 30 UNICEF. (n.d.). Module 1: What are the social, ecological model (SEM), communication for development (C4D)? Retrieved from https://www.unicef.org/cbsc/files/Module_1_SEMC4D.docx U.S. Department of Health and Human Services. (1994). Preventing tobacco use among young people: A report of the surgeon general. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Office on Smoking and Health. U.S. Department of Health and Human Services. (2012). Preventing tobacco use among youth and young adults: A report of the surgeon general. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. U.S. Department of Health and Human Services. (2014). The health consequences of smoking- 50 years of progress: A report of the surgeon general. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. U.S. Food and Drug Administration. (2017). Tobacco products: Family smoking prevention and tobacco control act. Retrieved from https://www.fda.gov/tobaccoproducts/labeling/ rulesregulationsguidance/ucm237092.htm U.S. Government Publishing Office. (2009). Family Smoking Prevention and Tobacco Control Act. Retrieved from http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/html/PLAW111publ31.htm Utah Department of Health. (2004). Tobacco prevention and control program: Ending nicotine dependence: Program evaluation. Retrieved from http://www.tobaccofreeutah.org /pdfs/ENDevaluation2004.pdf A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 31 Utah Department of Health. (2013). Tobacco Prevention and Control in Utah Thirteenth Annual Report. Retrieved from http://www.tobaccofreeutah.org/pdfs/tpcpfy13report.pdf Utah Department of Health. (2016). Electronic cigarette use among adults: United States. Retrieved from http://www.cdc.gov/nchs/data/databriefs/db217.pdf A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix A Phone Questionnaire of JJS Table A1 Nicotine Cessation Programs in Utah Juvenile Incarceration Secure Care Facilities Name of Facility Southwest Decker Lake Slate Canyon Farmington Bay Mill Creek Wasatch Total n 1 1 1 1 1 1 6 Presence of Nicotine Cessation Program Yes No X X X X X X Note. None of the six incarceration secure care facilities in Utah provide a nicotine cessation program to juveniles. 32 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 33 Appendix B Study Outline Module 1 Complete the pre-questionnaires. Talk about health effects. Help boys understand the cons of the behavior and the pros of changing. Pass out Nicotine Use Logs for the boys to track their tobacco and ENDS use to find personal patterns of use. Module 2 Talk about the Nicotine Use log at the beginning of the next session. Explain the cycle of nicotine addiction. Talk about the pros of quitting tobacco and nicotine. Talk about the various quitting strategies. Talk about the symptoms of recovery, and have boys determine how they can prepare for and overcome recovery symptoms. Have boys determine why they want to quit. Give information on waytoquit.org, the quit-line, and texting services. Module 3 Talk about the short and long-term effects of using tobacco and ENDS. With the use of Transtheoretical model (thinking about quitting) have the goal to help the group boys grasp that the pros of quitting outweigh the cons of quitting. Talk about dealing with stress. Talk about negative and positive coping methods and a routine that can help them deal with their stress instead. Module 4 Talk about the importance of effective communication in helping the boys to quit using tobacco and nicotine. Give examples of positive communication and have boys practice positive communication. Help the boys understand and use refusal skills. Have the boys identify people or sources they can turn to for help and support. Talk about self-esteem. Module 5 Talk about decision-making and problem-solving. Define what triggers are. Have the boys write down their ideas about what makes it difficult to quit and how they can overcome those difficulties. Talk goal setting. Module 6 Talk about the impact and influence of mass media on the lives of boys and how e-cigarette marketing influences them. Talk about the 8 Tools of Persuasion. Discuss what media background and how it is important for boys to be aware of the media traps. Module 7 Talk about the importance of healthy eating and physical activity, and how they can be used as tools to help boys during and after quitting. Review the dietary guidelines from Choose My Plate. Talk about how to avoid weight gain after quitting. Module 8 Have the boys complete the post-class questionnaire. Pick out what you are doing that is stopping you from being tobacco-free and nicotine-free. Talk about tips to avoid relapse. A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix C Pre-Questionnaire 34 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 35 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 36 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 37 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 38 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix D Post-Questionnaire 39 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 40 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 41 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 42 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix E Feasibility and Adoptability Questionnaire 43 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix F Providers and Stakeholders PPT 44 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 45 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 46 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 47 Appendix G Utah DHS IRB DEPARTMENT OF HUMAN SERVICES ANN SILVERBERG WILLIAMSON Executive Director State of Utah GARY R. HERBERT Governor SPENCER J. COX Lieutenant Governor LANA STOHL Deputy Director MARK BRASHER Deputy Director Date: 1/24/2018 Primary Investigator: Dallas Bowles DHS IRB Number: 0617 Please include this number on all subsequent correspondence Subject: A pilot study to promote abstinence from Nicotine: The effects of Ending Nicotine Dependence Program DHS IRB Review finding: Final Approval Thank you for your response to our previous letter and the modifications to your protocol. The Department of Human Services' Institutional Review Board (DHS IRB) has reviewed the modifications and approved the subject protocol. Expiration date: 1/23/2019 You may not conduct any research after this expiration date unless you submit a continuing review resubmission form that is approved by the DHS IRB or one of its representatives. If you suspect that your research will continue beyond the expiration date you must complete a new ongoing/amendment form along with a status report and resubmit for subsequent review and approval at least one month prior to expiration. If we have not received your resubmission prior to the expiration date, and if the research is ongoing, you will need to resubmit a full protocol application and request IRB approval. Additionally, data collected and/or analyzed during any period of time in which the IRB approval is not in effect, will have to be destroyed or discarded. Approved documents: Document Type Research Proposal Informed Consent/Assent Documents Recruitment Surveys Document Name As per final proposal. As per final proposal. As per final proposal. As per final proposal. A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 48 Appendix H Utah DHS IRB Continued Amendments: In the event that any further changes are made to the research following this approval (e.g., changes in target population, materials to which subjects are to be exposed, procedures to be employed, etc.), please document these changes on the included amendment form and send it to the DHS IRB. IRB Reviews: During the course of research, the protocol is subject to review by the DHS IRB and/or the DHS Bureau of Internal Review and Audit (BIRA) to ensure consistency and compliance with the IRB approval. This may include observing the assent and consent process and reviewing other elements of the research as approved by the IRB. DHS IRB contact information: If you need further assistance, please contact Dr. John DeWitt, Division of Juvenile Justice Services IRB Representative, at 801-538-4333 or [e-mail]. Final Report: Once your research is completed, please send a copy of your final report to the DHS IRB to allow its members and the Department to benefit from your research findings. Thank you for your cooperation during this review process and good luck in your endeavors. Sincerely, Frank M. Rees, Ph.D., Chair Bruce N. Larsen, Co-Chair DHS Institutional Review Board c John DeWitt Robbi Poulson 195 North 1950 West, Salt Lake City, UT 84116 Telephone: [phone] Fax: [phone] www.hs.utah.gov A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix I University of Utah IRB 49 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix J Demographics Table J1 Demographic Results Age Category Older than 18 Younger than 18 n=9 1 8 (12.5%) (87.5%) Race American Indian or Alaska Native African American Asian Hispanic or Latino Native Hawaiian or Pacific Islander White Other (specify) n=8 1 (12.5%) 1 (12.5%) 5 (62.5%) 1 (12.5%) Education Level Grade school Middle school High school College I do not attend school n=9 8 (87.5%) 1 (12.5%) 50 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix K Tobacco Use Table K1 Tobacco Use Have you ever tried Cigarette Cigars, cigarillos, o little cigars Tobacco in hookah or waterpipe Chewing tobacco, snuff or dip Electronic cigarettes, vape, or e-hookahs n=9 Onset of use Age 7-10 Age 10-13 Age 14-15 n=8 3 3 2 Quit Attempts Within 12 months have you attempt to quit n=8 9 8 100% 87.5% 9 100% 6 50% 9 100% 1 37.5% 37.5% 25% 12.5% 51 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix L Change of Intent Table L1 Change of Intent Pre-questionnaire Intent Not at all A little Somewhat A lot Post-questionnaire Intent Not at all A little Somewhat A lot n=7 6 1 86% 14% 4 2 1 57% 29% 14% 52 A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 53 Appendix M Staff and Provider Questionnaire Staff and Provider Questionnare 25% 50% RESPONDED TO GROUP'S NEEDS AND CONCERNS? 25% UNDERSTOOD THE NEEDS OF A DIVERSE GROUP? 25% 50% 25% 25% 50% 25% COMMUNICATED EFFECTIVELY? WAS SENSITIVE TO DIFFERENT CULTURES? 50% HOW WELL EXPLAINED WERE NEW CONCEPTS? Agree 25% 75% GAINED PARTICIPATION FROM EVERYONE? Strongly Agree 25% 75% Neutral 50% Disagree Strongly Disagree Figure M1. Staff and provider questionnaire Staff and Providers Questionnaire IS NICOTINE USE A BIG PROBLEM AMONG JUVENILES? 75% 25% 100% IS END PROGRAM NEEDED AT JJS? IS END PROGRAM AN APPROPRIATE FIT FOR JJS? DO YOU HAVE TIME TO IMPLEMENT THE END PROGRAM? WOULD YOU BE WILLING TO LEARN 1:1 COACHING TECHNIQUES OR LEAD A CLASS Strongly Agree Agree 25% 75% 50% 25% Neutral 50% Disagree Figure M2. Staff and provider questionnaire (continued) 25% 25% 25% Strongly Disagree A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE 54 Staff and Provider Questionnaire DO YOU FEEL LIKE END PROGRAM IS HELPFUL? DO YOU FEEL THE END PROGRAM, IS A REASONBLE FIT FOR JJS? 25% 75% 25% 75% 100% DO YOU FEEL THE END PROGRAM, IS NEEDED AT JJS? DO YOU FEEL THE END PROGRAM HAS REDUCED OR PREVENTED THE ONSET OF NICONTINE USE? Strongly Agree Agree Neutral 75% Disagree Figure M3. Staff and provider questionnaire (continued) 25% Strongly Disagree A PILOT STUDY TO PROMOTE ABSTINENCE FROM NICOTINE Appendix N Desire to Quit Smoking Figure N1. Desire to quit smoking 55