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Community-Based Integrated Treatment for Adolescents

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ClinicalTrials.gov Identifier: NCT01667159
Recruitment Status : Active, not recruiting
First Posted : August 17, 2012
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Depression Alcohol Use Behavioral: Integrated Cognitive Behavioral Therapy Behavioral: Standard Care Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adolescents With Major Depression and AUD: Community-Based Integrated Treatment
Study Start Date : July 2012
Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017
Arms and Interventions

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 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)


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 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