Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Medical University of South Carolina.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00438685
First received: February 21, 2007
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Substance-Related Disorders
Depressive Disorder
Anxiety Disorder
Behavioral: Outpatient MST/OPTION-A
Behavioral: Usual Services
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of Outpatient MST for Dually Diagnosed Youth

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

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

Estimated Enrollment: 40
Study Start Date: October 2004
Estimated Study Completion Date: September 2010
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438685

Locations
United States, South Carolina
Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Ashli J Sheidow, PhD Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
Study Chair: Scott W Henggeler, PhD Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ashli J. Sheidow, MUSC
ClinicalTrials.gov Identifier: NCT00438685     History of Changes
Other Study ID Numbers: 1R21DA017118 01, R21DA017118
Study First Received: February 21, 2007
Last Updated: July 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Substance-Related Disorders
Depressive Disorder
Anxiety Disorder
Adolescent
Behavior Therapy
Cognitive Therapy
Outpatients
Family Relations
Systems Theory

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

ClinicalTrials.gov processed this record on July 29, 2014