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

Primary Purpose

Adolescent, Depression, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adolescent Coping With Depression/Functional Family Therapy
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent focused on measuring Treatment efficacy, Family therapy, Teens, Substance abuse, Substance dependence

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

TX1

TX 2

TX 3

Arm Description

Functional Family Therapy (FFT) followed by Adolescent Coping With Depression (ACWD)

ACWD (Adolescent Coping With Depression) followed by FFT (Functional Family Therapy)

Combination of an augmented FFT and ACWD - Integrated treatment

Outcomes

Primary Outcome Measures

Children's Depression Rating Scale

Secondary Outcome Measures

Time Life Follow Back

Full Information

First Posted
May 16, 2008
Last Updated
March 10, 2014
Sponsor
Oregon Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00680966
Brief Title
Sequenced vs. Integrated Delivery of Treatment for Adolescent Depression and SUD
Acronym
Sequencing
Official Title
Sequenced vs. Integrated Delivery of Treatment for Adolescent Depression and SUD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent, Depression, Substance Use Disorders
Keywords
Treatment efficacy, Family therapy, Teens, Substance abuse, Substance dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TX1
Arm Type
Experimental
Arm Description
Functional Family Therapy (FFT) followed by Adolescent Coping With Depression (ACWD)
Arm Title
TX 2
Arm Type
Experimental
Arm Description
ACWD (Adolescent Coping With Depression) followed by FFT (Functional Family Therapy)
Arm Title
TX 3
Arm Type
Experimental
Arm Description
Combination of an augmented FFT and ACWD - Integrated treatment
Intervention Type
Behavioral
Intervention Name(s)
Adolescent Coping With Depression/Functional Family Therapy
Other Intervention Name(s)
FFT, ACWD
Intervention Description
ACWD- Cognitive behavioral group therapy for depressed adolescents FFT - Family therapy to address substance use disorders in adolescents
Primary Outcome Measure Information:
Title
Children's Depression Rating Scale
Time Frame
Intake, Mid-Treatment, Post, 6 months and 12 months follow-up
Secondary Outcome Measure Information:
Title
Time Life Follow Back
Time Frame
Intake, Mid-Treatment, Post, 6 months and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul D Rohde, Ph. D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

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

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