RECRUITING

Integrated Treatment for Enhancing Growth in Recovery During Adolescence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11-26
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06395467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 14-21 years old
  2. 2. SUD based on criteria from the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
  3. 3. able to read and comprehend English at a 5th-grade level
  4. 4. residence in Massachusetts or Connecticut
  5. 5. any AOD use in the past 90 days (or in the 90 days prior to being in a controlled environment)
  6. 6. meet patient placement criteria for level I (outpatient) treatment
  7. 7. participant and a family member/guardian responsible for providing collateral information (for those \<18 years) agree to sign Institutional Review Board (IRB)-approved consent
  8. 8. participant and family member responsible for providing collateral information who could be contacted in case the subject became lost to follow-up.
  1. 1. 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
  2. 2. lifetime diagnosis of schizophrenia
  3. 3. current health condition (i.e., medical, psychiatric) that compromises participant's ability to attend outpatient treatment
  4. 4. demonstrate inability or unwillingness to identify a "locator" who could be contacted in case participant becomes lost to follow-up; or
  5. 5. youth attending another SUD treatment program or receiving psychotherapy that could conflict with study treatments.

Contacts and Locations

Study Contact

Alexandra W Abry, BA
CONTACT
617-724-5259
aabry@mgh.harvard.edu
Jenny B O'Connor, BA
CONTACT
617-724-7932
jboconnor@mgh.harvard.edu

Principal Investigator

John F Kelly, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

UConn Health
Farmington, Connecticut, 06032
United States
MGH Department of Psychiatry
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • John F Kelly, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-26
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2024-11-26
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Cannabis Use Disorder