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

Not Applicable

Recruiting

• Conditions: Substance Use; Harm Reduction; Adolescent Behavior
• Interventions: Behavioral: iDECIDE

• Registration Number: NCT06115746
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Detailed Description

This study will be a two-arm, assessor-blind, randomized controlled trial enrolling approximately 300 middle and high school students who have recently violated a school substance use policy. Participants will be followed over a one-year period. Participants will be randomly assigned to either four-weeks of iDECIDE or a waitlist control group. Participants assigned to receive iDECIDE will receive a drug education curriculum developed to provide behavioral support and psychoeducation via videoconference or in-person visits. The purpose of iDECIDE is to provide students with the knowledge and skills they need to make healthy decisions regarding substance use. Participants in the waitlist control group will undergo symptom and substance use monitoring only, until completion of the one-month follow-up visit at which point they will be offered the opportunity to enroll in the iDECIDE curriculum, if desired. Data collection will occur during nine visits over the span of approximately one year, including one randomization baseline visit, four weekly visits during the intervention phase of the study during which time participants will participate in either iDECIDE or monitoring, and then four follow-up visits. The follow-up visits will occur at approximately one week, one month, six months, and one year following the end-of-intervention. Participants in both arms will complete questionnaires and assessments conducted by raters blinded to study arm assignment. Primary outcomes (knowledge of drug effects, knowledge of brain development and neurobiology of addiction, readiness to quit, perceptions of harm, and frequency of substance use) will be assessed at visit 1 (baseline), visit 5 (end-of-intervention), visit 6 (one week follow-up), and visit 7 (one month follow-up). Participants will be compensated for session attendance and provision of urine samples.

Study Timeline

• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Study Start: 2023-11-17
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-09-30
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Currently enrolled in middle or high school;
2. Violated school substance use policy within approximately the past month at the time of screening;
3. Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
4. Competent and willing to provide written informed assent (if under the age of 18) or written informed consent (if age 18 or older);
5. Able to commit to 9 study visits over approximately one year;
6. Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator;
7. Has access to a reliable internet connection and a device that can run Zoom;
8. Able to read and write comfortably in one of the languages spoken by study staff.

Exclusion Criteria

1. Ever received substance use treatment in an inpatient or specialty care setting;
2. Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease;
3. Ever engaged in intravenous (IV) drug use;
4. Current daily use of alcohol, non-medical benzodiazepines, and/or opioid use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iDECIDE	iDECIDE	Participants will... 1. Receive 4 weekly sessions of the iDECIDE drug curriculum. 2. Complete assessments and questionnaires, including self-reports of substance use and 4 urinalysis virtual visits. 3. Be video recorded for quality control.

Primary Outcome Measures

Name	Time	Method
Knowledge of Drug Effects and Brain Development	Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory)	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.
Readiness to Quit or Reduce Substance Use	Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory)	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).
Frequency of Substance Use	Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory)	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.
Perceived Harm of Substance Use	Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory)	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States