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| ID | Type | Description | Link |
|---|---|---|---|
| 24K09 | Other Grant/Funding Number | Florida Department of Health |
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| Name | Class |
|---|---|
| James and Esther King Biomedical Research Program | OTHER |
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Investigators will create and implement an e-cigarette intervention for Hispanic/Latino (H/L) high school youth. Focus groups with the target population (i.e., H/L high school students) and meetings with a community advisory board (CAB) will inform this intervention. The intervention will be tested with 120 H/L high school e-cigarette users to assess feasibility and promise for reducing use.
The e-cigarette cessation intervention will be grounded in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavioral Therapy, CBT; Cavallo et al., 2007; Krishnan-Sarin et al., 2013; Vinci et al., 2020) that has been found to be effective in both adults, as well as adolescents. The CBT intervention will likely include a total of 6 weekly sessions adapted for e-cigarettes that will be developed by the investigators and in consultation with a community advisory board. Based on initial feedback from focus groups, the sessions will likely take place in person, be in a group format, and be no longer than 50 minutes in duration. Some sessions will also include the adolescents' caregivers. We propose a "Preparation to Quit" session conducted approximately one week prior to quitting, which incorporates motivational strategies and assistance to aid quitting, set a quit day, and make a quit plan. This will be followed by a "pre-quit" session on the day before the quit day to review the quit plan, and then an additional session after the quit day that will focus on: 1) coping with cravings and withdrawal symptoms and identifying high risk situations, 2) becoming assertive, developing refusal skills, 3) stress/anger management skills, 4) problem-solving skills, 5) enhancing communication and family dynamics, 6) behavioral activation and community reinforcement, and 7) relapse prevention and coping with lapses. Session content and format will be adapted to be culturally relevant and integrate needs and strengths that are gleaned from focus groups. In addition to attending sessions, participants will be asked to complete an in-person baseline questionnaire session (~1hr) and a salivary cotinine assessment to objectively quantify recent nicotine exposure to verify current e-cigarette usage prior to their first cessation session. Participants will also be asked to complete a weekly 5-minute online survey on REDCap reflecting past week substance use. Participants will complete a salivary cotinine assessment to objectively quantify nicotine exposure during their last intervention session. Participants will also be asked to complete a follow-up questionnaire session (30 minutes) three months after they have completed the intervention, as well as a salivary cotinine assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Other | See Intervention Section |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette Cessation Manual | Behavioral | E-cigarette cessation manual development. Empirically supported treatment content. We anticipate grounding the intervention in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavior Therapy; CBT), which has been found to be effective with both adults and adolescents to quit cigarette smoking (Vinci, 2020). We anticipate including sessions that teach CBT skills to help adolescents quit e-cigarette use. These CBT skills and format will be adapted from prior manualized CBT smoking cessation interventions for adolescent smoking cessation and manualized CBT e-cigarette intervention for adolescents and young adults that are currently ongoing (e.g., Kong et al., 2017; Kong et al., 2021; Bold et al., 2022). The structure and content of the e-cigarette cessation manual will be further informed by themes and sub-themes from the focus group data analysis relating to both surface and deep structure cultural modifications. |
| Measure | Description | Time Frame |
|---|---|---|
| E-Cigarette Assessment for Youth-Revised checklist | This measure assesses the timing, brand, flavoring, quantity, and frequency of current and past e-cigarette use. | Baseline assessment: data will be reported on past 1-month and 1-year e-cigarette use Each weekly intervention session: data will be reported on past 1-week e-cigarette use Follow-up assessment: data will be reported on past 1-month e-cigarette use |
| Salivary cotinine samples | To biochemically verify self-reports of abstinence, saliva samples will be obtained using NicAlert cotinine test strips. | Saliva cotinine samples that can detect past-week nicotine use will be obtained at Baseline (Week 0), at the end of treatment (Week 6), and at the 3-month follow-up after treatment completion (Week 18). |
| Patient-Reported Outcomes Measurement Information System Nicotine Dependence Bank for E-Cigarettes | The Patient-Reported Outcomes Measurement Information System Nicotine Dependence Bank for E-Cigarettes (PROMIS-E) is a 4-item measure (each item scored on a 5-point Likert scale) that assesses nicotine dependence. Values range from 0 to 16 with higher scores representing worse outcomes. | Baseline assessment: data will be reported on past 1-month symptoms Each weekly intervention session: data will be reported on past 1-week symptoms Follow-up assessment: data will be reported on past 1-month symptoms |
| Questionnaire of Vaping Craving | The Questionnaire of Vaping Craving (QVC) is a 10-item measure (each item scored on a 7-point Likert scale) that assesses vaping craving. Values range from 10 to 70 with higher scores representing worse outcomes. | Baseline assessment: data will be reported on past 1-month craving Each weekly intervention session: data will be reported on past 1-week craving Follow-up assessment: data will be reported on past 1-month craving |
| Wisconsin Smoking Nicotine Withdrawal Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Timeline Followback questionnaire | Frequency and quantity of current and past use of other substances beyond e-cigarettes (e.g., other tobacco products, alcohol, cannabis) will also be queried. | Baseline assessment: data will be reported on past 1-month and past 1-year substance use Each weekly intervention session: data will be reported on past 1-week substance use Follow-up assessment: data will be reported on past 1-month substance use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FIU Center for Children and Families | Miami | Florida | 33199 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28523431 | Background | Bastiaens L, Galus J. The DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure as a Screening Tool. Psychiatr Q. 2018 Mar;89(1):111-115. doi: 10.1007/s11126-017-9518-7. | |
| 19019851 | Background | Benowitz NL, Bernert JT, Caraballo RS, Holiday DB, Wang J. Optimal serum cotinine levels for distinguishing cigarette smokers and nonsmokers within different racial/ethnic groups in the United States between 1999 and 2004. Am J Epidemiol. 2009 Jan 15;169(2):236-48. doi: 10.1093/aje/kwn301. Epub 2008 Nov 19. |
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To enhance the value and further the advancement of this research, we will consider sharing information collected from participants with other qualified individuals within the scientific community on a case-by-base basis while safeguarding the confidentiality/privacy of participants. Our underlying philosophy is to widely distribute, disseminate, and share all derived data and resources.
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As this is a pilot study, all participants (N=120) will be enrolled in the same vaping cessation program, which will be grounded in an empirically supported psychosocial smoking cessation program (i.e., Cognitive Behavioral Therapy, CBT) that has been found to be effective in both adults, as well as adolescents.
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The Wisconsin Smoking Nicotine Withdrawal Scale (WSWS) is a 28-item measure (each item scored on a 5-point Likert scale) that assesses nicotine withdrawal symptoms. Values range from 0 to 112 with higher scores representing worse outcomes. |
| Baseline assessment: data will be reported on past 1-week withdrawal symptoms Each weekly intervention session: data will be reported on past 1-week withdrawal symptoms Follow-up assessment: data will be reported on past 1-week withdrawal symptoms |
| Adolescent E-Cigarette Consequences Questionnaire | The Adolescent E-Cigarette Consequences Questionnaire (AECQ) is a 31-item measure (each item scored on a 5-point Likert scale) that assesses outcome expectancies when using an e-cigarette. Values range from 31 to 155 with higher scores representing worse outcomes. | Baseline assessment: data will be reported on past 1-week expectancies Follow-up assessment: data will be reported on past 1-week expectancies |
| PROMIS Emotional Distress Depression and Anxiety Pediatric Item Bank | This is a 5-item measure (each item scored on a 5-point Likert scale) that assesses symptoms of depression and anxiety. Values range from 0 to 20 with higher scores representing worse outcomes. | Baseline assessment: data will be reported on past 2-week symptoms experienced Follow-up assessment: data will be reported on past 2-week symptoms experienced |
| Parental Monitoring, Child Disclosure, and Relationship Quality | This 22-item measure (each item scored on a 5-point Likert scale) assesses parental monitoring, child disclosure, and relationship quality. Values range from 0 to 88 with higher scores representing better outcomes. | Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions |
| Resistance to Peer Influence | The Resistance to Peer Influence (RPI) is a 10-item measure (each item scored on a 4-point Likert scale) that assesses an adolescent's ability to resist peer influence across multiple hypothetical scenarios. Values range from 0 to 40 with higher scores representing better outcomes. | Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions |
| Multidimensional Scale of Perceived Social Support | Social support (e.g., friends, family members) will be measured by this 12-item (each item scored on a 7-point Likert scale) measure. Values range from 12 to 84 with higher scores representing better outcomes. | Baseline assessment: data will be reported on past 1-week perceptions Follow-up assessment: data will be reported on past 1-week perceptions |
| Treatment Acceptability | Participants will complete a survey encompassing multiple-choice questions and open-ended text boxes regarding their satisfaction with the vaping cessation program. | Final weekly intervention session: data will be reported on past 2-month general impressions with the treatment. |
| 34753093 | Background | Bold K, Kong G, Cavallo D, Davis D, Jackson A, Krishnan-Sarin S. School-based E-cigarette cessation programs: What do youth want? Addict Behav. 2022 Feb;125:107167. doi: 10.1016/j.addbeh.2021.107167. Epub 2021 Oct 28. |
| 18058412 | Background | Cavallo DA, Cooney JL, Duhig AM, Smith AE, Liss TB, McFetridge AK, Babuscio T, Nich C, Carroll KM, Rounsaville BJ, Krishnan-Sarin S. Combining cognitive behavioral therapy with contingency management for smoking cessation in adolescent smokers: a preliminary comparison of two different CBT formats. Am J Addict. 2007 Nov-Dec;16(6):468-74. doi: 10.1080/10550490701641173. |
| 32559666 | Background | Cristello JV, Sutherland MT, Trucco EM. A preliminary validation of the adolescent e-cigarette consequences questionnaire. Drug Alcohol Depend. 2020 Aug 1;213:108118. doi: 10.1016/j.drugalcdep.2020.108118. Epub 2020 Jun 12. |
| 29546379 | Background | Dowd AN, Motschman CA, Tiffany ST. Development and Validation of the Questionnaire of Vaping Craving. Nicotine Tob Res. 2019 Jan 1;21(1):63-70. doi: 10.1093/ntr/nty046. |
| 38679807 | Background | Hartmann SA, Cristello JV, Manresa O, Trucco EM. The e-cigarette assessment for youth-Revised (EAsY-R): Preliminary results of a pilot study of measure refinement via cognitive interviewing. J Res Adolesc. 2024 Sep;34(3):845-856. doi: 10.1111/jora.12957. Epub 2024 Apr 28. |
| 12745503 | Background | Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25. |
| 33162230 | Background | Kong G, Bold KW, Cavallo DA, Davis DR, Jackson A, Krishnan-Sarin S. Informing the development of adolescent e-cigarette cessation interventions: A qualitative study. Addict Behav. 2021 Mar;114:106720. doi: 10.1016/j.addbeh.2020.106720. Epub 2020 Oct 21. |
| 29048181 | Background | Kong G, Goldberg AL, Dallery J, Krishnan-Sarin S. An open-label pilot study of an intervention using mobile phones to deliver contingency management of tobacco abstinence to high school students. Exp Clin Psychopharmacol. 2017 Oct;25(5):333-337. doi: 10.1037/pha0000151. |
| 23523130 | Background | Krishnan-Sarin S, Cavallo DA, Cooney JL, Schepis TS, Kong G, Liss TB, Liss AK, McMahon TJ, Nich C, Babuscio T, Rounsaville BJ, Carroll KM. An exploratory randomized controlled trial of a novel high-school-based smoking cessation intervention for adolescent smokers using abstinence-contingent incentives and cognitive behavioral therapy. Drug Alcohol Depend. 2013 Sep 1;132(1-2):346-51. doi: 10.1016/j.drugalcdep.2013.03.002. Epub 2013 Mar 22. |
| 29753155 | Background | Morean ME, Krishnan-Sarin S, S O'Malley S. Assessing nicotine dependence in adolescent E-cigarette users: The 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Nicotine Dependence Item Bank for electronic cigarettes. Drug Alcohol Depend. 2018 Jul 1;188:60-63. doi: 10.1016/j.drugalcdep.2018.03.029. Epub 2018 Apr 26. |
| 8669520 | Background | Sobell LC, Cunningham JA, Sobell MB. Recovery from alcohol problems with and without treatment: prevalence in two population surveys. Am J Public Health. 1996 Jul;86(7):966-72. doi: 10.2105/ajph.86.7.966. |
| 11016567 | Background | Stattin H, Kerr M. Parental monitoring: a reinterpretation. Child Dev. 2000 Jul-Aug;71(4):1072-85. doi: 10.1111/1467-8624.00210. |
| 18020830 | Background | Steinberg L, Monahan KC. Age differences in resistance to peer influence. Dev Psychol. 2007 Nov;43(6):1531-1543. doi: 10.1037/0012-1649.43.6.1531. |
| 32415381 | Background | Vinci C. Cognitive Behavioral and Mindfulness-Based Interventions for Smoking Cessation: a Review of the Recent Literature. Curr Oncol Rep. 2020 May 16;22(6):58. doi: 10.1007/s11912-020-00915-w. |
| 10609970 | Background | Welsch SK, Smith SS, Wetter DW, Jorenby DE, Fiore MC, Baker TB. Development and validation of the Wisconsin Smoking Withdrawal Scale. Exp Clin Psychopharmacol. 1999 Nov;7(4):354-61. doi: 10.1037//1064-1297.7.4.354. |
| 2280326 | Background | Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095. |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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