Community-Based Integrated Treatment for Adolescents
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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 |
- Depression [ Time Frame: Measured at 18 months from baseline ] [ Designated as safety issue: No ]
- 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:
|
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 |
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| Contact: Anthony Spirito, Ph.D. | 401-444-1929 | anthony_spirito@brown.edu |
| 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 | |
| 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: | August 15, 2012 |
| 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 May 23, 2013