A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-22
SponsorMassachusetts General Hospital

About this trial

The primary goal of this study is to test the effectiveness of the iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment) curriculum, a novel drug education and diversion program, in approximately 300 middle and high school students, who have violated their school substance use policies in the past month, as an alternative to punitive school responses for school-based substance use infractions. This randomized controlled trial will test the hypothesis that adolescents randomized to the iDECIDE curriculum will have improved substance use outcomes (i.e., knowledge, attitudes, and behavior) compared to adolescents in a waitlist control group. The outcomes of this study will measure knowledge of drug effects and brain development, perceptions of harm from substance use, willingness to quit or reduce use, and substance use behavior.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Currently enrolled in middle or high school;

Violated school substance use policy within approximately the past month at the time of screening;

Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);

Competent and willing to provide written informed assent (if under the age of 18) or written informed consent (if age 18 or older);

Disqualifiers

Ever received substance use treatment in an inpatient or specialty care setting;

Ever engaged in intravenous (IV) drug use;

Current daily use of alcohol, non-medical benzodiazepines, and/or opioid use.

Trial design

Design model

Parallel

Treatments tested in this trial

  • iDECIDE

    Behavioral

    iDECIDE is a 4-session drug education and diversion program that addresses topics such as the neurobiology and addiction, adolescent brain development, industry tactics, motives for using substances, risk and protective factors, identifying triggers, healthy alternatives, core values, and long-term goal setting. These topics are taught via facilitated discussions, videos, worksheets, and handouts. The iDECIDE drug curriculum will be delivered weekly for 4 weeks via videoconference or in-person visits. Each session typically takes 60-75 minutes. For this study, facilitators are members of study staff.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: iDECIDEExperimental treatment 1 intervention
Group B: Waitlist Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Knowledge of Drug Effects and Brain Development

Knowledge of drug effects and brain development will be measured with a multiple choice questionnaire that assesses knowledge taught in the iDECIDE curriculum, including neurobiology of addiction, side effects of substance, and industry tactics to market substances to young audiences.

Time frame
Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
2

Frequency of Substance Use

The Timeline Follow-Back (TLFB) will be used to measure number of days the participant used a substance, which substances were used, and the frequency of which substances were used. The initial TLFB at the baseline visit will measure substances used in the past 90 days, while the interim TLFB will measure substances used since each subsequent visit. Participants will also provide a urine sample at study visits 1, 5, 6, 7 to qualitatively screen for substances including amphetamines, cocaine, barbiturates, methamphetamines, benzodiazepines, opiates, marijuana, phencyclidine, propoxyphene, and methaqualone using a urine 10-panel. There will also be an assay to quantitate levels of cotinine and creatinine-adjusted carboxy THC at baseline, end-of-intervention, one-week follow-up, and one-month follow-up. The primary outcome will be change in frequency of past week use (number of days) for the substance used most frequently at baseline.

Time frame
Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
3

Readiness to Quit or Reduce Substance Use

Participants will complete a Readiness Ruler to determine how ready they are to reduce their substance use on a scale from 1 (not at all ready) to 10 (very ready).

Time frame
Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
4

Perceived Harm of Substance Use

The Perceived Harm of Substance Use measure was modified from the 2010 National Survey on Drug Use and Health. Participants will assess their perceived harm of various forms of substance use using four response categories that range from no risk to great risk.

Time frame
Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)

Secondary outcomes

Other outcomes

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

Massachusetts Department of Health

Collaborator