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

NCT ID: NCT06115746

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-17
• Study Completion Date: 2028-07-31

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.

Conditions

Substance Use; Harm Reduction; Adolescent Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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 visits.

3. Be video recorded for quality control.

Group Type: EXPERIMENTAL

iDECIDE

Intervention Type: 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.

Waitlist Control Group

Participants will…

1. 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.

2. Undergo symptom monitoring during the weekly visits.

3. Complete assessments and questionnaires, including self-reports of substance use and 4 urinalysis visits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

iDECIDE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Drug Education Curriculum: Intervention, Diversion, and Empowerment

Eligibility Criteria

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. Ever engaged in intravenous (IV) drug use;

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Department of Health

OTHER_GOV

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Randi Melissa Schuster

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Randi M Schuster, PhD

Role: CONTACT

rschuster@mgh.harvard.edu

6176436673

Kendall Roberts

Role: CONTACT

kroberts20@mgh.harvard.edu

617-643-3574

Facility Contacts

Randi M Schuster, PhD

Role: primary

Rschuster@mgh.harvard.edu

617-643-6673

References

Liu J, Butler R, Turncliff A, Gray C, Lynch S, Whittaker J, Iroegbulem V, Howell D, Schuster RM. An Urgent Need for School-Based Diversion Programs for Adolescent Substance Use: A Statewide Survey of School Personnel. J Adolesc Health. 2023 Sep;73(3):428-436. doi: 10.1016/j.jadohealth.2023.04.006. Epub 2023 Jun 15.

Reference Type: BACKGROUND

PMID: 37318411 (View on PubMed)

Schuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023.

Reference Type: BACKGROUND

PMID: 37009114 (View on PubMed)

Other Identifiers

INTF2400H78500224455

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023P000808

Identifier Type: -

Identifier Source: org_study_id