Integrated Treatment for Enhancing Growth in Recovery During Adolescence

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
Massachusetts General Hospital
Study ID
NCT06395467
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • InTEGRA — BEHAVIORAL
    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
  • MET/CBT — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
Nov 26, 2024
Status verified
Nov 2025
Primary completion
May 1, 2028
Completion
May 31, 2028

Study Design

Enrollment
294 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: InTEGRA
    10 weekly, in-person or virtual treatment sessions (2 individually-delivered and 8 group sessions). InTEGRA contains many primary treatment elements of MET/CBT, but comparatively less time is spent on these elements to allow for the integration of the TSF content (about 50%). As part of this TSF, for example speakers from 12-step fellowships such as Marijuana Anonymous (MA), Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) are invited to share their experiences and discuss myths and facts related to attendance at 12-step meetings as well as answer any questions participants have about these fellowships. During an orientation session, parents of youth in the InTEGRA condition only (not MET/CBT alone) are given information about the potential benefits of 12-step meeting participation and a list of Young Person's 12-step meetings and encouraged to facilitate their child's participation during and after treatment.
  • Active Comparator: MET/CBT
    10 weekly, in-person or virtual treatment sessions (2 individually-delivered and 8 group sessions) modified from MET/CBT approaches (Webb, Scudder, Kaminer, \& Kadden, 2002; Sampl \& Kadden 2001) tested in the Cannabis Youth Treatment Study (Dennis et al. 2004).

Primary Outcome Measure

Percent Days Abstinent (PDA) [ Time Frame: During treatment and up to 12 months following enrollment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UConn HealthFarmingtonConnecticut06032
Marla Genova, MA
860.679.8165
Yifrah Kaminer, MD (PRINCIPAL_INVESTIGATOR)
MGH Department of PsychiatryBostonMassachusetts02114
Alexandra W Abry, BA
617-724-5259
Jenny B O'Connor, BA
617-724-7932
John F Kelly, PhD (PRINCIPAL_INVESTIGATOR)

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