ClinicalTrials.gov
ClinicalTrials.gov Menu

Sequenced vs. Integrated Delivery of Treatment for Adolescent Depression and SUD (Sequencing)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00680966
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Adolescent Depression Substance Use Disorders Behavioral: Adolescent Coping With Depression/Functional Family Therapy Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequenced vs. Integrated Delivery of Treatment for Adolescent Depression and SUD
Study Start Date : January 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: TX1
Functional Family Therapy (FFT) followed by Adolescent Coping With Depression (ACWD)
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
Other Names:
  • FFT
  • ACWD
Experimental: TX 2
ACWD (Adolescent Coping With Depression) followed by FFT (Functional Family Therapy)
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
Other Names:
  • FFT
  • ACWD
Experimental: TX 3
Combination of an augmented FFT and ACWD - Integrated treatment
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
Other Names:
  • FFT
  • ACWD



Primary Outcome Measures :
  1. Children's Depression Rating Scale [ Time Frame: Intake, Mid-Treatment, Post, 6 months and 12 months follow-up ]

Secondary Outcome Measures :
  1. Time Life Follow Back [ Time Frame: Intake, Mid-Treatment, Post, 6 months and 12 months follow-up ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

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): NCT00680966


Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Paul D Rohde, Ph. D. Oregon Research Institute

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00680966     History of Changes
Other Study ID Numbers: DA021357
1R01DA021357 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

Keywords provided by Oregon Research Institute:
Treatment efficacy
Family therapy
Teens
Substance abuse
Substance dependence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Substance-Related Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Chemically-Induced Disorders