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Community-Based Integrated Treatment for Adolescents

Primary Purpose

Depression, Alcohol Use

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Integrated Cognitive Behavioral Therapy
Standard Care
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Alcohol Use, Outpatient Therapy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated Cognitive Behavioral Therapy

Standard Care

Arm Description

Adolescents and their parent(s) will receive integrated cognitive behavioral therapy.

Adolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program.

Outcomes

Primary Outcome Measures

Depression

Secondary Outcome Measures

Alcohol/Substance Use

Full Information

First Posted
August 14, 2012
Last Updated
January 21, 2018
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01667159
Brief Title
Community-Based Integrated Treatment for Adolescents
Official Title
Adolescents With Major Depression and AUD: Community-Based Integrated Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Alcohol Use
Keywords
Depression, Alcohol Use, Outpatient Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Adolescents and their parent(s) will receive integrated cognitive behavioral therapy.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Adolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT for adolescents and parents
Intervention Description
Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Other Intervention Name(s)
Intensive Outpatient Therapy, Treatment As Usual (TAU)
Intervention Description
Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.
Primary Outcome Measure Information:
Title
Depression
Time Frame
Measured at 18 months from baseline
Secondary Outcome Measure Information:
Title
Alcohol/Substance Use
Time Frame
Measured at 18 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Spirito, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34238628
Citation
Spirito A, Nestor B, Massing-Schaffer M, Esposito-Smythers C, Stout R, Frazier E, Gomez J, Graves H, Yen S, Hunt J, Wolff J. Predictors and moderators of marijuana and heavy alcohol use outcomes in adolescents treated for co-occurring substance use and psychiatric disorders in a randomized controlled trial. J Subst Abuse Treat. 2021 Dec;131:108536. doi: 10.1016/j.jsat.2021.108536. Epub 2021 Jun 15.
Results Reference
derived
PubMed Identifier
33607509
Citation
MacPherson HA, Wolff J, Nestor B, Frazier E, Massing-Schaffer M, Graves H, Esposito-Smythers C, Spirito A. Parental Monitoring Predicts Depressive Symptom and Suicidal Ideation Outcomes in Adolescents Being Treated for Co-Occurring Substance Use and Psychiatric Disorders. J Affect Disord. 2021 Apr 1;284:190-198. doi: 10.1016/j.jad.2021.02.021. Epub 2021 Feb 9.
Results Reference
derived

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Community-Based Integrated Treatment for Adolescents

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