Community-Based Integrated Treatment for Adolescents

January 21, 2018 updated by: Anthony Spirito, Brown University

Adolescents With Major Depression and AUD: Community-Based Integrated Treatment

This study will examine the effectiveness of an integrated treatment for adolescents who are depressed and use alcohol in an intensive outpatient setting in the community.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies have consistently shown that alcohol use disorders (AUDs) and mental health disorders are related in adolescence. For example, in a community sample, teens who reported a history of AUD were almost four times as likely to have a history of Major Depressive Disorder (MDD) than teens with no history of AUD. The scientific community has only recently begun to examine how to treat adolescents with both AUD and MDD. Reviews have concluded that depression negatively affects treatment for substance abuse. At the same time, substance use issues are often not assessed or addressed in outpatient psychotherapy. Thus, we believe that protocols are needed to specifically address substance abusing, depressed adolescents. This study is designed to determine if an integrated (CBT-I) protocol designed to treat both substance use and depression in adolescents aged 12 to 18 years with AUD/MDD will produce better treatment outcomes compared to standard care (CBT-SC). Both the integrated CBT-I and CBT-SC conditions will be delivered by licensed mental health workers at a community mental health clinic - Gateway - that uses an Intensive Outpatient Program (IOP) model to treat adolescents with AUD and mental health disorders. Two hundred adolescents (50 per year for 4 years) will be recruited from Gateway's Dual Diagnosis IOP. If an adolescent screens in by reporting both depressed mood and substance abuse, these eligible families will complete a thorough baseline assessment and will then be assigned to either CBT-I or CBT-SC. The baseline battery will be repeated at the end of treatment, and 6 and 12 months after treatment completion to determine how families in the study do over time.

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

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.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English speaking adolescent and parent
  • Current substance use disorder
  • Co-occurring psychiatric symptomatology

Exclusion Criteria:

  • IQ < 80
  • Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
  • Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated Cognitive Behavioral Therapy
Adolescents and their parent(s) will receive integrated cognitive behavioral therapy.
Behavioral: Integrated Cognitive Behavioral Therapy
Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months.
Other Names:
  • CBT for adolescents and parents
Active Comparator: Standard Care
Adolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program.
Behavioral: Standard Care
Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.
Other Names:
  • Treatment As Usual (TAU)
  • Intensive Outpatient Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression
Time Frame: Measured at 18 months from baseline
Measured at 18 months from baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Alcohol/Substance Use
Time Frame: Measured at 18 months from baseline
Measured at 18 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Anthony Spirito, Ph.D., Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 21, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01AA020705-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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