A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol.
Randi M Schuster, Corinne Cather, Gladys N Pachas...
https://pubmed.ncbi.nlm.nih.gov/37009114/Actively Recruiting
Led by Massachusetts General Hospital · Updated on 2025-10-30
300
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the iDECIDE curriculum, a new drug education and diversion program, in about 300 middle and high school students who have recently broken school substance use rules. This randomized controlled trial aims to see if iDECIDE improves knowledge about drugs, attitudes toward substance use, and actual substance use behavior compared to a waitlist control group. The study focuses on adolescents understanding of drug effects, brain development, and readiness to reduce or quit substance use. Participants will be randomly assigned to one of two groups the iDECIDE group or a waitlist control group. The iDECIDE group will complete four weekly sessions of a drug education curriculum, delivered via videoconference or in-person, each lasting 60 to 75 minutes. This curriculum covers topics such as addiction neurobiology, brain development, industry tactics, and healthy alternatives. The control group will undergo symptom and substance use monitoring during the weekly visits and may choose to join the iDECIDE program after one month. The study involves nine visits over about one year, including baseline assessment, four weekly intervention or monitoring visits, and four follow-up visits at one week, one month, six months, and one year after the intervention. Participants will complete questionnaires, assessments, and urine tests at various visits, with raters blinded to group assignment. The study will measure knowledge of drug effects and brain development, frequency of substance use, readiness to quit, and perceptions of harm. Participants will receive compensation for attending sessions and providing urine samples.
CONDITIONS
A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
R
Randi M Schuster, PhD
K
Kendall Roberts
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Massachusetts General Hospital
Lead Sponsor
Massachusetts Department of Health
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | iDECIDE intervention | No intervention control |
|---|---|---|
| What it is | A four‑session drug education and diversion program taught weekly via videoconference or in person | Participants remain on a waitlist and receive no intervention during the study period |
| Role in the trial | Investigational behavioral intervention arm | Control arm receiving no study intervention during the trial |
| Primary use | To reduce substance use and increase knowledge, perceived harm and readiness to change among students who violated school substance use policy | Serves as control to assess change in outcomes over time without intervention |
| How it is given or performed | Delivered through four 60‑ to 75‑minute sessions weekly by study‑trained facilitators using videoconference or in‑person formats | No sessions or educational content are delivered during the trial period |
| Evidence status | Effectiveness under investigation; no published results yet | No intervention—effectiveness not applicable |
| Important risks | null | null |
| Important limitations | Results not yet available; long‑term impact unknown | As a no‑intervention control, does not inform comparative effectiveness versus existing programs |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 4 weeks
Participants receive either 4 weekly sessions of the iDECIDE drug education curriculum via videoconference or in-person visits, or undergo symptom and substance use monitoring if assigned to the waitlist control group.
4 weekly visits
Duration - Approximately 1 year
Participants complete assessments at approximately 1 week, 1 month, 6 months, and 1 year after the end of the intervention to monitor knowledge, substance use, and readiness to change.
4 follow-up visits
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/37318411/Massachusetts General Hospital
Lead Sponsor
Massachusetts Department of Health
Collaborating Sponsor