Integrated treatment to help adolescents recover from substance use disorders
Integrated Treatment for Enhancing Growth in Recovery During Adolescence (InTEGRA)
This study is testing a new combined therapy approach to help teenagers aged 14-21 recover from alcohol and cannabis use disorders and see if it works better than the standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Ages | 14 Years to 21 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Farmington, Connecticut and 1 other locations) |
| Trial ID | NCT06395467 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 294 adolescents aged 14-21 with substance use disorders, specifically alcohol and cannabis use disorders. It compares two psychosocial interventions: Integrated Treatment for Enhancing Growth in Recovery During Adolescence (InTEGRA), which combines 12-Step Facilitation with Motivational Enhancement Therapy/Cognitive Behavioral Therapy, against the standard MET/CBT alone. Participants are recruited from clinical settings and the community in Massachusetts and Connecticut, and are randomized to treatment conditions. Follow-up assessments occur every three months for one year after treatment completion to evaluate outcomes.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 14-21 who have a diagnosed substance use disorder and reside in Massachusetts or Connecticut.
Not a fit: Patients with severe mental health issues, such as suicidal ideation or schizophrenia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery rates and better long-term outcomes for adolescents struggling with substance use disorders.
How similar studies have performed: Previous studies have shown promise in using integrated psychosocial interventions for substance use disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. 14-21 years old 2. SUD based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) 3. able to read and comprehend English at a 5th-grade level 4. residence in Eastern time zone states (Connecticut, Delaware, Florida, Georgia, Indiana, Kentucky, Maine, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, and West Virginia 5. any AOD use in the past 90 days (or in the 90 days prior to being in a controlled environment) 6. meet patient placement criteria for level I (outpatient) treatment 7. participant and a family member/guardian responsible for providing collateral information (for those \<18 years) agree to sign Institutional Review Board (IRB)-approved consent 8. participant and family member responsible for providing collateral information who could be contacted in case the subject became lost to follow-up. Exclusion criteria: 1. suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or others, or a history of self-injurious behavior occurring in past 30 days 2. lifetime diagnosis of schizophrenia 3. current health condition (i.e., medical, psychiatric) that compromises participant's ability to attend outpatient treatment 4. demonstrate inability or unwillingness to identify a "locator" who could be contacted in case participant becomes lost to follow-up; or 5. youth attending another SUD treatment program or receiving psychotherapy that could conflict with study treatments.
Where this trial is running
Farmington, Connecticut and 1 other locations
- UConn Health — Farmington, Connecticut, United States (Recruiting)
- MGH Department of Psychiatry — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: John F Kelly, PhD — Massachusetts General Hospital
- Study coordinator: Alexandra W Abry, BA
- Email: aabry@mgh.harvard.edu
- Phone: 617-724-5259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.