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Community-Based Integrated Treatment for Adolescents

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Anthony Spirito, Brown University
ClinicalTrials.gov Identifier:
NCT01667159
First received: August 14, 2012
Last updated: July 31, 2017
Last verified: July 2017
  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
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Adolescents With Major Depression and AUD: Community-Based Integrated Treatment

Further study details as provided by Anthony Spirito, Brown University:

Primary Outcome Measures:
  • Depression [ Time Frame: Measured at 18 months from baseline ]

Secondary Outcome Measures:
  • Alcohol/Substance Use [ Time Frame: Measured at 18 months from baseline ]

Estimated Enrollment: 114
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
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   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Anthony Spirito, Ph.D. Brown University
  More Information

Responsible Party: Anthony Spirito, Professor, Brown University
ClinicalTrials.gov Identifier: NCT01667159     History of Changes
Other Study ID Numbers: 1R01AA020705-01A1 ( U.S. NIH Grant/Contract )
Study First Received: August 14, 2012
Last Updated: July 31, 2017

Keywords provided by Anthony Spirito, Brown University:
Depression
Alcohol Use
Outpatient Therapy

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

ClinicalTrials.gov processed this record on August 16, 2017