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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Substance Use, Harm Reduction, Adolescent Behavior

Intervention / Treatment
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* Behavioral: iDECIDE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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); Able to commit to 9 study visits over approximately one year; Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator; Has access to a reliable internet connection and a device that can run Zoom; Able to read and write comfortably in one of the languages spoken by study staff. Exclusion Criteria: Ever received substance use treatment in an inpatient or specialty care setting; Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease; Ever engaged in intravenous (IV) drug use; Current daily use of alcohol, non-medical benzodiazepines, and/or opioid use.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Approximately 300 participants will be enrolled into a two-arm, assessor-blind, randomized controlled trial to compare substance use outcomes (i.e., knowledge, behavior, and attitudes) across a one-year follow-up period in adolescents randomly assigned to the iDECIDE drug curriculum or the waitlist control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iDECIDE<br>Participants will… Receive 4 weekly sessions of the iDECIDE drug curriculum. Complete assessments and questionnaires, including self-reports of substance use and 4 urinalysis virtual visits. Be video recorded for quality control. | Behavioral: iDECIDE<br>* 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.<br>* Other names: Drug Education Curriculum: Intervention, Diversion, and Empowerment;|
| No Intervention: Waitlist Control Group<br>Participants will… Not receive the iDECIDE curriculum during the weekly visits. They can choose to self-enroll in the iDECIDE curriculum at their one-month follow up visit. Undergo symptom monitoring during the weekly visits. Complete assessments and questionnaires, including self-reports of substance use and 4 urinalysis virtual visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory) | 
| 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. | Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory) | 
| 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). | Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory) | 
| 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. | Baseline to 1-month follow-up (primary) and 1-year follow-up (exploratory) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Diversion program, iDECIDE, Tier 2, School, Substance use prevention, Addiction, Early intervention, Targeted prevention