Community-Based Integrated Treatment for Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Brown University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anthony Spirito, Brown University
ClinicalTrials.gov Identifier:
NCT01667159
First received: August 14, 2012
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Depression
Alcohol Use
Behavioral: Integrated Cognitive Behavioral Therapy
Behavioral: Standard Care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adolescents With Major Depression and AUD: Community-Based Integrated Treatment

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Depression [ Time Frame: Measured at 18 months from baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alcohol/Substance Use [ Time Frame: Measured at 18 months from baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • Intensive Outpatient Therapy
  • Treatment As Usual (TAU)

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking adolescent and parent
  • Current alcohol use disorder
  • Current major depressive disorder

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667159

Contacts
Contact: Anthony Spirito, Ph.D. 401-444-1929 anthony_spirito@brown.edu

Locations
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02912
Contact: Anthony Spirito, Ph.D.    401-444-1929    anthony_spirito@brown.edu   
Contact: Jennifer Wolff, Ph.D.    401-444-3790    jennifer_wolff@brown.edu   
Principal Investigator: Anthony Spirito, PhD         
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Anthony Spirito, Ph.D. Brown University
  More Information

No publications provided

Responsible Party: Anthony Spirito, Professor, Brown University
ClinicalTrials.gov Identifier: NCT01667159     History of Changes
Other Study ID Numbers: 1R01AA020705-01A1, 1R01AA020705-01A1
Study First Received: August 14, 2012
Last Updated: July 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Brown University:
Depression
Alcohol Use
Outpatient Therapy

Additional relevant MeSH terms:
Alcohol Drinking
Depression
Depressive Disorder
Drinking Behavior
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014