Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School Students

Not Applicable

Terminated

• Conditions: Health Risk Behaviors; Substance Use; Adolescent Behavior; Youth

• Registration Number: NCT05321563
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The primary goal of this study is to evaluate the effectiveness of the iDECIDE curriculum as an alternative to punitive responses for school-based substance use infractions.

Detailed Description

The primary goal of this study is to evaluate the effectiveness of the iDECIDE curriculum as an alternative to punitive responses for school-based substance use infractions. To accomplish this aim, investigators will conduct a Type 1, hybrid effectiveness-implementation trial. Using a stepped wedge design, investigators will randomly allocate the timing of implementation of the iDECIDE curriculum compared to standard disciplinary response, over approximately 24 months. Investigators are testing the overarching hypothesis that student-level outcomes improve when schools transition from a standard disciplinary response to having access to a more educational and therapeutic alternative. Participants for this aim will include students referred by schools with substance use infractions who are assessed by the study team at baseline (proximal to the time of infraction), 45, and 90 days later.

Exploratory aims of this study include:

1. Change in school environment -- Evaluating the impact of transition from punitive responses for substance use to iDECIDE on overall prevalence of substance use and perceptions of school culture. Participants for this exploratory aim include all students within participating schools (not just those with substance use infractions), assessed annually beginning Fall 2022.

2. Single arm pre/post change -- Evaluating change from session 1 to session 4 of iDECIDE in perceptions of harm from substance use, knowledge of drug effects, perceptions of a supportive school culture, plans to change substance use, and frequency of past 7-day substance use in all students who complete the iDECIDE curriculum. Investigators will also explore whether any change in these outcomes differ among historically underserved populations, including racial and gender minority students. Participants for this exploratory aim incIude all students who participate in the iDECIDE curriculum, regardless of the reason for referral into the program and the provision of parental consent for collection of data for primary aims.

3. Identification of implementation barriers -- Evaluating the feasibility and acceptability of the iDECIDE curriculum by identifying multi-level barriers and facilitators to implementation using mixed methods. Participants for this exploratory aim include school stakeholders, interviewed right before and 6 months following iDECIDE implementation.

Study Timeline

• Study Start: 2022-02-04
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-11
• Primary Completion: 2023-09-14
• Study Completion: 2023-09-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Enrolled in a participating middle or high school;
• Received a substance use-related infraction at school or school-sanctioned event;
• 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 consent (if age 18+) or assent (if under 18);
• Able to read and write comfortably in English;
• In the opinion of the investigator, able to safely participate in the protocol.

Exclusion Criteria

• Passive consent for referral to MGH evaluation team declined by parent or legal guardian;
• Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease;
• Ward of the state.

Eligibility criteria for participants for exploratory aims:

In addition to the students with school-based substance use infractions enrolled for the primary aims, three additional cohorts of participants will be recruited for exploratory aims. The eligibility criteria for these cohorts are listed below.

Exploratory Aim 1: evaluating the impact of transition from punitive responses for substance use to iDECIDE on overall prevalence of substance use and perceptions of school culture (Annual School-Wide Assessment)

Inclusion Criteria:

• Currently enrolled in a participating middle or high school;
• Provide informed assent/consent for participation in this research by voluntarily completing the survey.

Exclusion Criteria:

• Passive consent for school-wide assessment declined by parent or legal guardian;
• Not able to adequately read and respond to survey items in one of the languages available.

Exploratory Aim 2: Evaluating change from session 1 to session 4 of iDECIDE in perceptions of harm from substance use, knowledge of drug effects, perceptions of a supportive school culture, plans to change substance use, and frequency of past 7-day substance use in all students who complete the iDECIDE curriculum.

Inclusion Criteria:

• Enrolled in the iDECIDE curriculum by a trained iDECIDE facilitator.

Exclusion Criteria:

• Unable to adequately read and respond to survey items in one of the languages available.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knowledge of drug effects from baseline to 90 day follow-up	Baseline - 90 days	Knowledge of drug effects will be measured by number of items correct on a survey examining a student's understanding of adolescent brain development, neurobiology of addiction, and the impact of alcohol, cannabis, nicotine and other substance use on the brain and body.
Frequency of substance use from baseline to 90 day follow-up	Baseline - 90 days	Frequency of substance use will be operationalized as the number of days spent using student's preferred substance assessed via 14-day timeline followback.

Secondary Outcome Measures

Name	Time	Method
Emotional support from baseline to 90 day follow-up	Baseline - 90 days	Quality of relationships with teachers/administrators, school connectedness, and social and emotional satisfaction at school will be measured using summed scores from the NIH Toolbox Emotional Support Fixed Form Ages 8-17 v2.0, modified to specifically query about emotional support from adults in school. Raw scores range from 7 to 33 (age- and gender- corrected T-scores also available), with higher scores indicative of more social support.

Trial Locations

Locations (1)

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