RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-17
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06115746

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years to 22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Currently enrolled in middle or high school;
  2. 2. Violated school substance use policy within approximately the past month at the time of screening;
  3. 3. Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
  4. 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. 5. Able to commit to 9 study visits over approximately one year;
  6. 6. Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator;
  7. 7. Has access to a reliable internet connection and a device that can run Zoom;
  8. 8. Able to read and write comfortably in one of the languages spoken by study staff.
  1. 1. Ever received substance use treatment in an inpatient or specialty care setting;
  2. 2. Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease;
  3. 3. Ever engaged in intravenous (IV) drug use;
  4. 4. Current daily use of alcohol, non-medical benzodiazepines, and/or opioid use.

Contacts and Locations

Study Contact

Randi M Schuster, PhD
CONTACT
6176436673
rschuster@mgh.harvard.edu
Caroline Gray, MSW
CONTACT
617-643-1771
CGRAY16@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-17
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2023-11-17
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Adolescent
  • Diversion program
  • iDECIDE
  • Tier 2
  • School
  • Substance use prevention
  • Addiction
  • Early intervention
  • Targeted prevention

Additional Relevant MeSH Terms

  • Substance Use
  • Harm Reduction
  • Adolescent Behavior