Integrated Treatment for Enhancing Growth in Recovery During Adolescence

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-21
SponsorMassachusetts General Hospital

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

14-21 years old

SUD based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)

able to read and comprehend English at a 5th-grade level

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

Disqualifiers

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

lifetime diagnosis of schizophrenia

current health condition (i.e., medical, psychiatric) that compromises participant's ability to attend outpatient treatment

demonstrate inability or unwillingness to identify a "locator" who could be contacted in case participant becomes lost to follow-up; or

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

294 Participants
are divided into 2 treatment groups
Group A: InTEGRAExperimental treatment 1 intervention
Group B: MET/CBTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Days Abstinent (PDA)

Percent Days Abstinent (PDA) from alcohol and other drugs (cannabis, opioids, etc.). Derived from Timeline Followback (TLFB) and Form-90 measures of substance use. Abstinence reports confirmed with Breathalyzer and Toxicology Screen data.

Time frame
During treatment and up to 12 months following enrollment
2

Substance use related consequences

Substance use related consequences as measured by the Short Inventory of Problems - Revised (SIP-2R), a 15-item measure with response options from 0 to 3 (minimum = 0 and maximum = 45); higher scores correspond with more consequences.

Time frame
During treatment and up to 12 months following enrollment

Secondary outcomes

1

Psychiatric symptom severity

Measure of psychiatric symptoms as assessed by the Brief Symptom Inventory-18 (BSI-18), an 18-item measure with response options from 0 to 4 (minimum = 0 and maximum = 72 which are converted to gender normed T scores of M = 50 and SD = 10); higher scores correspond with more symptomatology.

Time frame
During treatment and up to 12 months following enrollment.

Other outcomes

1

Percent days attending 12-step meetings

Percentage of days attending one or more 12-step mutual-help meetings derived from adapted version of Timeline Followback (TLFB).

Time frame
During treatment and up to 12 months following enrollment.

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator