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NCT Number: NCT06395467

Integrated Treatment for Enhancing Growth in Recovery During Adolescence

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Cannabis Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

14 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Health, Farmington, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • any AOD use in the past 90 days (or in the 90 days prior to being in a controlled environment)
  • meet patient placement criteria for level I (outpatient) treatment
  • participant and a family member/guardian responsible for providing collateral information (for those <18 years) agree to sign Institutional Review Board (IRB)-approved consent
  • participant and family member responsible for providing collateral information who could be contacted in case the subject became lost to follow-up.

Exclusion criteria

  • 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
  • youth attending another SUD treatment program or receiving psychotherapy that could conflict with study treatments.

Treatment and study plan

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

Primary outcomes

  1. Percent Days Abstinent (PDA)

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

    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.

  2. Substance use related consequences

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

    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.

Secondary outcomes

  1. Psychiatric symptom severity

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

    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.

Other outcomes

  1. Percent days attending 12-step meetings

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra W Abry, BA

CONTACT

[email protected]

617-724-5259

Jenny B O'Connor, BA

CONTACT

[email protected]

617-724-7932

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: InTEGRA

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 2, 2024
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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