Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders
Primary Purpose
Substance-Related Disorders, Depressive Disorder, Anxiety Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Outpatient MST/OPTION-A
Usual Services
Sponsored by
About this trial
This is an interventional treatment trial for Substance-Related Disorders focused on measuring Substance-Related Disorders, Depressive Disorder, Anxiety Disorder, Adolescent, Behavior Therapy, Cognitive Therapy, Outpatients, Family Relations, Systems Theory
Eligibility Criteria
Inclusion Criteria:
- Presentation for outpatient treatment
- 12 to 17 years of age
- Youth residing with at least one adult caregiver who serves as a parent figure
- Substance Abuse or Dependence Disorder
- Axis I Internalizing Disorder (Mood Disorder or Anxiety Disorder), based on the Diagnostic Interview Schedule for Children (DISC-IV; Shaffer, Fisher, Lucas, Dulcan, & Schwab-Stone, 2000)
Exclusion Criteria:
- Pervasive Developmental Disorder
- Psychotic Disorder
- Severe or profound mental retardation (IQ of 45 or below)
- Families previously receiving Multisystemic Therapy
Sites / Locations
- Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
Outcomes
Primary Outcome Measures
Urine Drug Screen at 4 weeks, 8 weeks, 12 weeks, 24 weeks
Score on Depression/Anxiety Scale (RCADS) at 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary Outcome Measures
Measured at Intake, 3 Months, and 6 Months
Global assessment of symptoms
Parenting
School
Behavioral
Family relationship/communication/problem solving
Consumer satisfaction
Daily Drug/Alcohol use
Full Information
NCT ID
NCT00438685
First Posted
February 21, 2007
Last Updated
June 13, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00438685
Brief Title
Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders
Official Title
Development of Outpatient MST for Dually Diagnosed Youth
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
Adolescent substance abuse results in significant negative outcomes and extraordinary costs for youths, their families, communities, and society. Moreover, rates of psychiatric comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual diagnosis have worse outcomes and are more than twice as costly to treat than their counterparts with no comorbidity. This project was a pilot test of a new treatment, OPTION-A, which was adapted from Multisystemic Therapist (MST) and other evidence-based interventions to specifically treat youth presenting for outpatient treatment of comorbid substance use and internalizing disorders. The project was a randomized controlled pilot trial comparing the experimental treatment to usual services in the community.
Detailed Description
Adolescent substance abuse results in significant negative outcomes and extraordinary costs for youths, their families, communities, and society. Moreover, rates of psychiatric comorbidity among substance abusing youth are high and youths with a dual diagnosis are more costly to treat. At the time of this study, however, no outpatient treatments had been tested specifically for treating youth with co-occurring substance use disorders and mental health diagnoses. The current project aimed to adapt and evaluate Multisystemic Therapy (MST), a well validated treatment for chronic behavioral problems or serious emotional disturbance in adolescents, to treat dually diagnosed youth using an outpatient model of service delivery.
A pilot trial was conducted with 40 dually diagnosed youth randomly assigned to treatment conditions, with 20 receiving the experimental treatment (OPTION-A) and 20 receiving usual outpatient services. Specific aims were:
Specific Aim 1: The primary aim of the present research was to adapt and test OPTION-A for use in outpatient settings to treat youth diagnosed with a substance use disorder and comorbid internalizing disorder. We hypothesized that youth receiving OPTION-A would exhibit significantly less drug use (e.g., youth self-reports and urine screens) than control youth who received usual services, and that youth receiving OPTION-A would exhibit significant improvement on indices of mental health (e.g., combined youth and caregiver reports on diagnostic interviews and youth, caregiver, and teacher reports of internalizing symptoms) compared to control youth Specific Aim 2: In addition to improved symptomatology, the current research aimed to test the effectiveness of OPTION-A to improve youth functioning in other domains pertinent to successful adolescent development. We hypothesized that youth receiving OPTION-A would evidence improved behavioral (e.g., youth, caregiver, and teacher reports of externalizing), school (e.g., school attendance), and family functioning (e.g., youth and caregiver reports of family adaptability and cohesion) compared to control youth who received usual services.
Specific Aim 3: The final aim of the proposed research was to provide services that are more acceptable to consumers than are usual services provided in the community. We hypothesized that youth and families receiving OPTION-A would experience significantly greater consumer satisfaction than control youth and families who received usual services.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Depressive Disorder, Anxiety Disorder
Keywords
Substance-Related Disorders, Depressive Disorder, Anxiety Disorder, Adolescent, Behavior Therapy, Cognitive Therapy, Outpatients, Family Relations, Systems Theory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Outpatient MST/OPTION-A
Intervention Type
Behavioral
Intervention Name(s)
Usual Services
Primary Outcome Measure Information:
Title
Urine Drug Screen at 4 weeks, 8 weeks, 12 weeks, 24 weeks
Title
Score on Depression/Anxiety Scale (RCADS) at 4 weeks, 8 weeks, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Measured at Intake, 3 Months, and 6 Months
Title
Global assessment of symptoms
Title
Parenting
Title
School
Title
Behavioral
Title
Family relationship/communication/problem solving
Title
Consumer satisfaction
Title
Daily Drug/Alcohol use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presentation for outpatient treatment
12 to 17 years of age
Youth residing with at least one adult caregiver who serves as a parent figure
Substance Abuse or Dependence Disorder
Axis I Internalizing Disorder (Mood Disorder or Anxiety Disorder), based on the Diagnostic Interview Schedule for Children (DISC-IV; Shaffer, Fisher, Lucas, Dulcan, & Schwab-Stone, 2000)
Exclusion Criteria:
Pervasive Developmental Disorder
Psychotic Disorder
Severe or profound mental retardation (IQ of 45 or below)
Families previously receiving Multisystemic Therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashli J Sheidow, PhD
Organizational Affiliation
Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott W Henggeler, PhD
Organizational Affiliation
Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
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Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders
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