InTEGRA vs. MET/CBT for Youth with Alcoholism and Drug Use Disorder

(InTEGRA Trial)

Recruiting at 1 trial location

Overseen By Jenny B O'Connor, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Suicidal ideation, Schizophrenia, Health condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 10 weeks

294 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are attending another substance use disorder treatment program or receiving psychotherapy that could conflict with the study treatments, you may not be eligible to participate.

What data supports the effectiveness of the InTEGRA treatment for youth with alcoholism and drug use disorder?

Research on Integrated Family and Cognitive-Behavioral Therapy (IFCBT), which shares similarities with InTEGRA, shows it significantly reduces alcohol and marijuana use among adolescents with substance use disorders. This suggests that integrated approaches combining family involvement and cognitive-behavioral strategies can be effective for treating youth with substance use issues. ^{1 2 3 4 5}

Is InTEGRA (Integrated Family and Cognitive-Behavioral Therapy) safe for adolescents with substance use disorders?

In a study evaluating Integrated Family and Cognitive-Behavioral Therapy (IFCBT) for adolescents with substance use disorders, no harmful effects were observed among the participants, suggesting that this therapy is generally safe for use in this population. ^{1 2 5 6 7}

How does the InTEGRA treatment differ from other treatments for youth with alcohol and drug use disorder?

InTEGRA is unique because it combines Motivational Enhancement Therapy (MET) and Cognitive Behavioral Therapy (CBT), which are both designed to help youth change their substance use behaviors by enhancing motivation and teaching coping skills. This integrated approach is different from standard treatments that may focus on just one method, offering a more comprehensive strategy to address both the psychological and behavioral aspects of substance use disorders. ^{2 8 9 10 11}

Research Team

John F Kelly, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adolescents aged 14-21 with substance use disorder, specifically alcohol and cannabis use issues. They must be able to attend sessions in Boston, MA or Farmington, CT. Details on who can't join are not provided.

Inclusion Criteria

DSM 5 alcohol and other drug (AOD) use disorder to maximize generalizability to youth with broad range of AOD involvement

Residence within 60-minute drive from the Boston MGH/Harvard and Farmington UConn treatment sites

Have used AOD in the past 90 days (or in the 90 days prior to being in a controlled environment)

Exclusion Criteria

Lifetime diagnosis of schizophrenia

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

Youth attending another AOD treatment program or receiving psychotherapy that could conflict with study treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phone screening followed by in-person intake

Treatment

Participants receive 10 weekly treatment sessions, either InTEGRA or MET/CBT, with a mix of individual and group sessions

10 weeks

10 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-ups every 3 months for one year

12 months

4 visits (in-person or virtual)

Treatment Details

Interventions

• InTEGRA
• MET/CBT

Trial Overview The study compares two treatments for young people with drug problems: InTEGRA combined with MET/CBT versus just MET/CBT. The goal is to see if InTEGRA leads to more involvement in recovery programs, higher sobriety rates, and fewer negative consequences from substance use.

Participant Groups

Group I: InTEGRA Experimental Treatment 1 Intervention

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.

Group II: MET/CBT Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

Integrated Family and Cognitive-Behavioral Therapy (IFCBT) significantly reduced substance use in adolescents compared to the Drugs Harm Psychoeducation curriculum (DHPE), with IFCBT participants using alcohol an average of 2.03 days per month versus 6.06 days for DHPE participants, and marijuana 5.67 days versus 13.83 days, respectively.

IFCBT not only decreased substance use but also improved psychosocial skills in youth and adaptive communication and involvement in parents, indicating its effectiveness in addressing both individual and family dynamics in treating adolescent drug abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated family and cognitive-behavioral therapy for adolescent substance abusers: a stage I efficacy study. Latimer, WW., Winters, KC., D'Zurilla, T., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Twelve-Step attendance trajectories over 7 years among adolescents entering substance use treatment in an integrated health plan. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Integrated family and cognitive-behavioral therapy for adolescent substance abusers: a stage I efficacy study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The effectiveness of the Minnesota Model approach in the treatment of adolescent drug abusers. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Listening to youth: Adolescents' reasons for substance use as a unique predictor of treatment response and outcome. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Multidimensional Family Therapy as a community-based alternative to residential treatment for adolescents with substance use and co-occurring mental health disorders. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Alcohol use disorders in adolescents: epidemiology, diagnosis, psychosocial interventions, and pharmacological treatment. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Evidence-based treatments for alcohol use disorders in adolescents. [2008]

8. United States pubmed.ncbi.nlm.nih.gov

Internalizing and externalizing behaviors and their association with the treatment of adolescents with substance use disorder. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Integrated cognitive behaviour therapy for co-occurring substance misuse and major depression: lessons from a youth mental health service. [2018]

10. England pubmed.ncbi.nlm.nih.gov

A case-matched comparison of readmission patterns between primary methamphetamine-using and primary cocaine-using adolescents engaged in inpatient substance-abuse treatment. [2007]

11. England pubmed.ncbi.nlm.nih.gov

On the learning curve: the emerging evidence supporting cognitive-behavioral therapies for adolescent substance abuse. [2022]