NCT06395467

Integrated Treatment for Enhancing Growth in Recovery During Adolescence

Integrated Treatment for Enhancing Growth in Recovery During Adolescence (InTEGRA)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II parallel group randomized controlled trial with 294 adolescents (age: 14-21 years) with alcohol and other drug \[AOD\] use disorder (hereafter substance use disorder), that compares two different active psychosocial interventions designed to address adolescent substance use disorder. Participants are recruited from our clinical settings and the community at two sites: one in the metro Boston, Massachusetts (MA) area and the other in the metro Farmington, Connecticut (CT), area. Study aims and hypotheses are as follows: 1. To extend the evidence for the initial efficacy of Integrated Treatment for Enhancing Growth in Recovery During Adolescence (InTEGRA), which integrates 12-Step Facilitation (TSF) with Motivational Enhancement Therapy/Cognitive Behavioral Therapy (MET/CBT) relative to gold standard MET/CBT alone (N = 294). It is hypothesized that youth assigned to InTEGRA will have greater 12-step participation during and following treatment, higher abstinence rates, and fewer substance-related negative consequences. 2. Investigate the personal recovery capital (PRC) and social recovery capital (SRC) mechanisms of behavior change through which InTEGRA may confer benefits dynamically over time (e.g., PRC: motivation, self-efficacy, coping; SRC: 12-step involvement; social network changes). 3. Investigate moderators of InTEGRA's effects on outcomes across one-year follow-up (e.g., effect of age, network support for AOD use; psychiatric severity; age composition of 12-step meetings on substance use and substance-related consequences). It is hypothesized that higher network support for AOD use, abstinence motivation, and greater AOD severity, will have a better response to InTEGRA. 4. Explore barriers and facilitators to InTEGRA adoption and implementation across providers and system administrators within the context of a type I hybrid effectiveness-implementation research design.

Detailed description

Interested individuals will be screened by phone, followed by a more rigorous screening completed at intake. With the anticipated sample size of 294, expected enrollment is between 6-7 participants per month across the two sites during the enrollment period (about 3-4 per site). Participants are randomized to treatment conditions in a 1:1 ratio using a computerized urn randomization program (stratified by age and gender) The study data analyst will share this information with the treatment providers once a given group is ready to begin. The research assistants conducting assessments will be blinded to condition assignment. Beginning at treatment conclusion (approximately 3 months after enrollment), participants are followed up every 3 months for one year following their baseline enrollment date. The treatment conditions are InTEGRA, which integrates key elements of TSF with MET/CBT, and MET/CBT alone.

Conditions

• Alcohol Use Disorder
• Cannabis Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	InTEGRA	Session topics are as follows: Parent Info Session - Informational and Q\&A format; Motivation Building- Addressing AA/NA Expectancies and Experiences; AA/NA Expectancies and Treatment Goal Setting Session; Alcohol and Drug Refusal Skills; Coping with Urges and Other Thoughts about Drinking; Problem Solving; Anger Management (AA/NA and Hungry, Angry, Lonely, Tired "HALT"; Effective Communication (Sharing at AA/NA meetings; getting a sponsor); Depression Management; Using AA/NA for enhancing Social Support and Increasing Pleasant Activities; Planning for Emergencies and Coping with Relapse
BEHAVIORAL	MET/CBT	Session topics are as follows: Motivation Building Session; Goal Setting Session; Alcohol and Drug Refusal Skills; Coping with Urges and Other Thoughts about Drinking; Problem Solving; Anger Management; Effective Communication; Depression Management; Enhancing the Social Support Network and Increasing Pleasant Activities; Planning for Emergencies and Coping with Relapse

Timeline

• Start date: 2024-11-26
• Primary completion: 2028-05-01
• Completion: 2028-05-31
• First posted: 2024-05-02
• Last updated: 2026-03-06

Locations

2 sites across 1 country: United States