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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00680966
Other study ID # DA021357
Secondary ID 1RO1-DA021357
Status Completed
Phase N/A
First received May 16, 2008
Last updated March 10, 2014
Start date January 2008
Est. completion date June 2013

Study information

Verified date March 2014
Source Oregon Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether it is more effective to treat adolescents, with diagnoses of both depression and substance use disorder, with a treatment addressing the substance use first and then treating the depression or to first treat the depression and then treat the substance use or whether treating both disorders simultaneously is most effective.

It is expected that treatment of both disorders at the same time will be the most effective.


Description:

Comorbidity is a well established aspect of adolescent psychopathology. The majority of adolescents entering treatment have more than one condition. This study will evaluate service delivery methods of integrating empirically supported interventions for depression and non-nicotine substance use disorders (SUD)in an effort to improve treatment engagement, response, and maintenance of gains. The two examined interventions are the Adolescent Coping With Depression course (ACWD) and Functional Family Therapy (FFT).

This study will expand upon previous research by systematically treating both depression and SUD. Over a 5 year period, 180 adolescents with depression/SUD and their parents/guardians will be recruited in Oregon and New Mexico and randomly assigned to 1 of 3 conditions: (a) FFT followed by ACWD, (b) ACWD followed by FFT, or (c) an intervention combining and augmenting FFT and ACWD (Integrated Treatment). Each treatment arm will consist of 24 sessions provided over 20 weeks. Participants will be assessed at intake, after the provision of 6, 12 (Mid-treatment), 18 and 24 (Post-treatment)treatment sessions, and at 6 and 12 month follow-ups.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date June 2013
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria:

1. DSM-IV-TR diagnosis of depression, defined as MDD, dysthymia, or substance-induced mood disorder meeting MDD or dysthymia symptom criteria

2. DSM-IV-TR diagnosis of one or more non-nicotine SUD

3. Some reported illicit drug use in the last 90 days

4. 13-17 years of age

5. parent or guardian willing to participate in study

6. basic English competency (ability to converse in English)

Exclusion Criteria:

1. Current and acute suicidal ideation at the level warranting inpatient treatment

2. current psychotic symptoms

3. the adolescent's sibling is already participating in the study

4. if on psychiatric medications, a significant change in dosage levels in the prior 4 weeks -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Adolescent Coping With Depression/Functional Family Therapy
ACWD- Cognitive behavioral group therapy for depressed adolescents FFT - Family therapy to address substance use disorders in adolescents

Locations

Country Name City State
United States Oregon Research Institute Eugene Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Children's Depression Rating Scale Intake, Mid-Treatment, Post, 6 months and 12 months follow-up No
Secondary Time Life Follow Back Intake, Mid-Treatment, Post, 6 months and 12 months follow-up No
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