- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680966
Sequenced vs. Integrated Delivery of Treatment for Adolescent Depression and SUD (Sequencing)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97403
- Oregon Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- DSM-IV-TR diagnosis of depression, defined as MDD, dysthymia, or substance-induced mood disorder meeting MDD or dysthymia symptom criteria
- DSM-IV-TR diagnosis of one or more non-nicotine SUD
- Some reported illicit drug use in the last 90 days
- 13-17 years of age
- parent or guardian willing to participate in study
- basic English competency (ability to converse in English)
Exclusion Criteria:
- Current and acute suicidal ideation at the level warranting inpatient treatment
- current psychotic symptoms
- the adolescent's sibling is already participating in the study
- if on psychiatric medications, a significant change in dosage levels in the prior 4 weeks -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TX1
Functional Family Therapy (FFT) followed by Adolescent Coping With Depression (ACWD)
|
ACWD- Cognitive behavioral group therapy for depressed adolescents FFT - Family therapy to address substance use disorders in adolescents
Other Names:
|
|
Experimental: TX 2
ACWD (Adolescent Coping With Depression) followed by FFT (Functional Family Therapy)
|
ACWD- Cognitive behavioral group therapy for depressed adolescents FFT - Family therapy to address substance use disorders in adolescents
Other Names:
|
|
Experimental: TX 3
Combination of an augmented FFT and ACWD - Integrated treatment
|
ACWD- Cognitive behavioral group therapy for depressed adolescents FFT - Family therapy to address substance use disorders in adolescents
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Children's Depression Rating Scale
Time Frame: Intake, Mid-Treatment, Post, 6 months and 12 months follow-up
|
Intake, Mid-Treatment, Post, 6 months and 12 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time Life Follow Back
Time Frame: Intake, Mid-Treatment, Post, 6 months and 12 months follow-up
|
Intake, Mid-Treatment, Post, 6 months and 12 months follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul D Rohde, Ph. D., Oregon Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA021357
- 1R01DA021357 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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