Testing a School-Based E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention Curriculum for Guam Youths

NCT05037656 | Completed

• 2 other identifiers: 2U54CA143728-11U54CA143728
• Study Type: interventional
• Target: 538
• Locations: 1 country
• Sites: 1

Brief Summary

The people of the U.S. Affiliated Pacific Islands (USAPI) face higher cancer incidence, especially lung/bronchia and head-and-neck cancer, and poorer cancer outcomes, compared with the U.S. nationally. This may partly be driven by the high rates of cigarette smoking and betel (areca) nut use in the USAPI. Previous data suggest that that adolescents on Guam, as young as middle school students report markedly higher e-cigarette and tobacco product use prevalence in the USAPI compared with the USAPI nationally. Guam youths are also at risk for the use of betel nuts. Yet, currently there are no tobacco product/areca nut use prevention programs that have been developed for and tested specifically USAPI adolescents. The proposed study will develop a school-based substance use prevention curriculum for e-cigarette, tobacco product, and areca nut use prevention among Guam youths. The curriculum will use lessons incorporating innovative videos and culturally grounded activities. The study's specific aims are:

1. 1.To develop a school-based curriculum for e-cigarette, tobacco product (i.e., cigarette, smokeless tobacco), and betel nut use prevention among middle school students in Guam.
2. 2.Test the efficacy of the school-based curriculum in a randomized controlled trial.

Conditions

Tobacco Smoking; Vaping; Tobacco Chewing

Keywords

tobacco; e-cigarette; Areca nut; Prevention; Adolescents

Outcome Measures

Primary Outcomes (2)

• Changes in Youth Risk Behavior Surveillance (YRBS) Survey-based self-reported past-30-day tobacco, e-cigarette, and areca nut use

  Tobacco, e-cigarette, and areca nut use behavior will be assessed using a standardized self-report measure of recent use that is use in the national YRBS survey. The questionnaire item will ask: "In the past 30 days, on how many days did you smoke a cigarette?" This question will be adapted for e-cigarette and areca nut. Response options include: "0 days," "1-2 days," "3-5 days," "6-9 days," "10-19 days," "20-29 days," "all 30 days."

  Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up)

• Changes in Pierce's Smoking Susceptibility Scale (also adapted for e-cigarette and areca nut use)

  This is a standardized self-report measure containing 4 items originally designed to assess smoking susceptibility among adolescents. In addition to the original measure, the current study will also adapt the measure to assess e-cigarette and areca nut use susceptibility. The 4 items are: "Do you think you will smoke a cigarette soon?", "Do you think you will smoke a cigarette in the next year?", "Do you think in the future you might experiment with cigarettes?", "If one of you friends were to offer you a cigarette, would you smoke it?"

  Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up)

Secondary Outcomes (4)

• Kendall Wilcox Self-control Scale

  Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up)

• Jackson et al.'s Social Competence Scale

  Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up)

• Sherer et al.'s General Self-Efficacy Scale

  Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up)

• Flay et al.'s Refusal Self-Efficacy

  Outcomes will be assessed at baseline (pre-test), 5 weeks after baseline, immediately following curriculum/standard of care delivery (i.e., post-test), and 6 months after baseline (follow-up)

Study Arms (2)

Control

NO INTERVENTION

Students in the control group will receive the standard health education curriculum.

Experimental

EXPERIMENTAL

Students in the treatment group will receive the school-based classroom curriculum.

Behavioral: School-based curriculum

Interventions

School-based curriculum BEHAVIORAL

Participants will be randomized, at the school level, to receive either the e-cigarette/tobacco/areca nut use prevention curriculum or the standard of care (i.e., control). The curriculum will be implemented using 5 intensive in-class lessons over the span of 6 weeks. All sessions of the curriculum follow the same basic format: a) an introduction and/or review of the past lesson, b) a cultural wall activity, c) a video, d) 1-2 interactive activities, and e) a wrap-up activity. Lessons are designed such as to help improve knowledge about drugs and correct cognitive misperceptions and to train on skills to resist normative social influence. Participants will complete identical survey questionnaires for assessments at 3 time-points: pretest (baseline, before implementing the intervention), immediate posttest (following the end of the intervention), and six-month follow-up. The surveys will be administered in the classroom, during regular school hours.

Experimental

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All students enrolled in public middle schools in Guam (age: 11-15 years old)
• Provide signed parental informed consent and student assent

You may not qualify if:

• Participants whose parents decline participation or students who decline participation.

Sponsors & Collaborators

• University of Guam: lead
• National Cancer Institute (NCI): collaborator
• University of Hawaii Cancer Research Center: collaborator

Study Sites (1)

Guam Department of Education

Tiyan, Guam, Guam

Location

Related Publications (21)

• Okamoto SK, Helm S, Ostrowski LK, Flood L. The Validation of a School-Based, Culturally Grounded Drug Prevention Curriculum for Rural Hawaiian Youth. Health Promot Pract. 2018 May;19(3):369-376. doi: 10.1177/1524839917704210. Epub 2017 Apr 26.

  PMID: 28443350 BACKGROUND

• Okamoto SK, Helm S, Chin SK, Hata J, Hata E, Okamura KH. The implementation of a culturally grounded, school-based, drug prevention curriculum in rural Hawai'i. J Community Psychol. 2020 May;48(4):1085-1099. doi: 10.1002/jcop.22222. Epub 2019 Jul 23.

  PMID: 31332808 BACKGROUND

• Okamoto SK, Helm S, McClain LL, Dinson AL. The development of videos in culturally grounded drug prevention for rural native Hawaiian youth. J Prim Prev. 2012 Dec;33(5-6):259-69. doi: 10.1007/s10935-012-0281-0.

  PMID: 23143071 BACKGROUND

• Flay BR. The promise of long-term effectiveness of school-based smoking prevention programs: a critical review of reviews. Tob Induc Dis. 2009 Mar 26;5(1):7. doi: 10.1186/1617-9625-5-7.

  PMID: 19323827 BACKGROUND

• Pokhrel P, Sussman S, Stacy A. Relative effects of social self-control, sensation seeking, and impulsivity on future cigarette use in a sample of high-risk adolescents. Subst Use Misuse. 2014 Mar;49(4):343-51. doi: 10.3109/10826084.2013.841241. Epub 2013 Oct 4.

  PMID: 24093522 BACKGROUND

• Okamoto SK, Helm S, Pel S, McClain LL, Hill AP, Hayashida JK. Developing empirically based, culturally grounded drug prevention interventions for indigenous youth populations. J Behav Health Serv Res. 2014 Jan;41(1):8-19. doi: 10.1007/s11414-012-9304-0.

  PMID: 23188485 BACKGROUND

• Herzog TA, Murphy KL, Little MA, Suguitan GS, Pokhrel P, Kawamoto CT. The Betel Quid Dependence Scale: replication and extension in a Guamanian sample. Drug Alcohol Depend. 2014 May 1;138:154-60. doi: 10.1016/j.drugalcdep.2014.02.022. Epub 2014 Feb 26.

  PMID: 24629627 BACKGROUND

• Moss J, Kawamoto C, Pokhrel P, Paulino Y, Herzog T. Developing a Betel Quid Cessation Program on the Island of Guam. Pac Asia Inq. 2015 Fall;6(1):144-150.

  PMID: 27057560 BACKGROUND

• Dalisay F, Buente W, Benitez C, Herzog TA, Pokhrel P. Adolescent betel nut use in Guam: beliefs, attitudes and social norms. Addict Res Theory. 2019;27(5):394-404. doi: 10.1080/16066359.2018.1538410. Epub 2019 Jan 11.

  PMID: 31231175 BACKGROUND

• Gentzke AS, Creamer M, Cullen KA, Ambrose BK, Willis G, Jamal A, King BA. Vital Signs: Tobacco Product Use Among Middle and High School Students - United States, 2011-2018. MMWR Morb Mortal Wkly Rep. 2019 Feb 15;68(6):157-164. doi: 10.15585/mmwr.mm6806e1.

  PMID: 30763302 BACKGROUND

• Oakley E, Demaine L, Warnakulasuriya S. Areca (betel) nut chewing habit among high-school children in the Commonwealth of the Northern Mariana Islands (Micronesia). Bull World Health Organ. 2005 Sep;83(9):656-60. Epub 2005 Sep 30.

  PMID: 16211156 BACKGROUND

• Milgrom P, Tut OK, Gilmatam J, Gallen M, Chi DL. Areca use among adolescents in Yap and Pohnpei, the Federated States of Micronesia. Harm Reduct J. 2013 Oct 17;10:26. doi: 10.1186/1477-7517-10-26.

  PMID: 24134714 BACKGROUND

• Paulino YC, Novotny R, Miller MJ, Murphy SP. Areca (Betel) Nut Chewing Practices in Micronesian Populations. Hawaii J Public Health. 2011 Mar;3(1):19-29.

  PMID: 25678943 BACKGROUND

• Soneji S, Barrington-Trimis JL, Wills TA, Leventhal AM, Unger JB, Gibson LA, Yang J, Primack BA, Andrews JA, Miech RA, Spindle TR, Dick DM, Eissenberg T, Hornik RC, Dang R, Sargent JD. Association Between Initial Use of e-Cigarettes and Subsequent Cigarette Smoking Among Adolescents and Young Adults: A Systematic Review and Meta-analysis. JAMA Pediatr. 2017 Aug 1;171(8):788-797. doi: 10.1001/jamapediatrics.2017.1488.

  PMID: 28654986 BACKGROUND

• Buente W, Dalisay F, Pokhrel P, Kramer HK, Pagano I. An Instagram-Based Study to Understand Betel Nut Use Culture in Micronesia: Exploratory Content Analysis. J Med Internet Res. 2020 Jul 9;22(7):e13954. doi: 10.2196/13954.

  PMID: 32673220 BACKGROUND

• Pierce JP, Choi WS, Gilpin EA, Farkas AJ, Berry CC. Tobacco industry promotion of cigarettes and adolescent smoking. JAMA. 1998 Feb 18;279(7):511-5. doi: 10.1001/jama.279.7.511.

  PMID: 9480360 BACKGROUND

• Wills TA, Bantum EO, Pokhrel P, Maddock JE, Ainette MG, Morehouse E, Fenster B. A dual-process model of early substance use: tests in two diverse populations of adolescents. Health Psychol. 2013 May;32(5):533-42. doi: 10.1037/a0027634.

  PMID: 23646836 BACKGROUND

• Jackson C, Henriksen L, Dickinson D, Levine DW. The early use of alcohol and tobacco: its relation to children's competence and parents' behavior. Am J Public Health. 1997 Mar;87(3):359-64. doi: 10.2105/ajph.87.3.359.

  PMID: 9096534 BACKGROUND

• Sherer M, Mercandante JEMB, Prentice-Dunn S, Jacobs B, Rogers RW. The self-efficacy scale: construction and validation. Psychological Reports. 1982;51(2):663-71.

  BACKGROUND

• Flay BR, Hu FB, Siddiqui O, Day LE, Hedeker D, Petraitis J, Richardson J, Sussman S. Differential influence of parental smoking and friends' smoking on adolescent initiation and escalation of smoking. J Health Soc Behav. 1994 Sep;35(3):248-65.

  PMID: 7983337 BACKGROUND

• Dalisay F, Okamoto SK, Kawabata Y, Herzog TA, Pokhrel P. A pilot stratified cluster randomized trial of school-based e-cigarette and other tobacco product use prevention for Pacific Island youths: An evaluation of the Fuetsan Manhoben curriculum. Tob Induc Dis. 2026 Mar 24;24. doi: 10.18332/tid/218296. eCollection 2026.

  PMID: 41884082 DERIVED

MeSH Terms

Conditions

Tobacco Smoking; Vaping; Tobacco Use

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Officials

• Francis Dalisay, PhD

  University of Guam

  PRINCIPAL INVESTIGATOR

• Pallav Pohkrel, PhD

  University of Hawaii Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: September 8, 2021
• Study Start: September 14, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)