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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

August 14, 2012
July 28, 2014
July 2012
March 2017   (final data collection date for primary outcome measure)
Depression [ Time Frame: Measured at 18 months from baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01667159 on ClinicalTrials.gov Archive Site
Alcohol/Substance Use [ Time Frame: Measured at 18 months from baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Community-Based Integrated Treatment for Adolescents
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Alcohol Use
  • 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
  • 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)
  • Experimental: Integrated Cognitive Behavioral Therapy
    Adolescents and their parent(s) will receive integrated cognitive behavioral therapy.
    Intervention: Behavioral: Integrated Cognitive Behavioral Therapy
  • Active Comparator: Standard Care
    Adolescents and their parent(s) will receive treatment as usual through a community intensive outpatient program.
    Intervention: Behavioral: Standard Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2017
March 2017   (final data collection date for primary outcome measure)

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
Both
12 Years to 18 Years
No
Contact: Anthony Spirito, Ph.D. 401-444-1929 anthony_spirito@brown.edu
United States
 
NCT01667159
1R01AA020705-01A1, 1R01AA020705-01A1
Yes
Anthony Spirito, Brown University
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Anthony Spirito, Ph.D. Brown University
Brown University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP