Community-Based Integrated Treatment for Adolescents

Depression Clinical Trial

Official title:

Adolescents With Major Depression and AUD: Community-Based Integrated Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667159
• Other study ID #: 1R01AA020705-01A1
• Secondary ID: 1R01AA020705-01A
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2012
• Last updated: January 21, 2018
• Start date: July 2012
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use
• Depression
• Depressive Disorder

Intervention

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.
• Standard Care
Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression		Measured at 18 months from baseline
Secondary	Alcohol/Substance Use		Measured at 18 months from baseline