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Research on Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders

Primary Purpose

Substance-Related Disorders, Depressive Disorder, Anxiety Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
OutPatient Treatment for Adolescents (OPT-A)
Treatment As Usual
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders

Eligibility Criteria

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

Inclusion Criteria:

  • 10 to 17 years of age
  • Residing with at least one adult caregiver who serves as a parent figure
  • In need of treatment for a Substance Abuse or Dependence Disorder
  • In need of treatment for an Axis I Mood Disorder and/or Anxiety Disorder

Exclusion Criteria:

  • Pervasive Developmental Disorder
  • Active Psychotic Disorder
  • Severe or profound mental retardation

Sites / Locations

  • Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OPT-A

Treatment as Usual

Arm Description

OPT-A is an outpatient family-based treatment for co-occurring substance use and internalizing disorders

Treatment as usual in a community based mental health center

Outcomes

Primary Outcome Measures

Substance use
Mental Health

Secondary Outcome Measures

Full Information

First Posted
May 4, 2010
Last Updated
April 10, 2015
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01117753
Brief Title
Research on Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders
Official Title
Stage II Research on Outpatient Treatment for Adolescents With Comorbidity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

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 are more than twice as costly to treat compared to those with no comorbidity. The applicant principal investigator recently completed a pilot project funded by the National Institute on Drug Abuse focused on developing and piloting a psychosocial treatment specifically for youth presenting for outpatient treatment with co-occurring substance use and internalizing (i.e., mood and/or anxiety) problems. Results were promising with the experimental group exhibiting significantly less substance use and more rapid reductions in anxiety and depressive symptoms compared to the control group. The proposed research is a randomized clinical trial (RCT) to compare the experimental treatment (OutPatient Treatment for Adolescents; OPT-A) to an "active placebo" on key clinical indices from pre-treatment through 18 months. The proposed RCT (n = 160) employs the treatment manual, quality assurance protocol, and therapist training protocol developed and successfully tested in the pilot study, to evaluate the efficacy of OPT-A for youth referred to outpatient treatment of co-occurring substance use and internalizing problems. The following outcomes will be evaluated: drug use; mental health; behavioral, school, peer, and family functioning; and consumer satisfaction. The intervention addresses one of the more prevalent and most challenging, costly, and understudied presenting problems among adolescent outpatients. If successful, this research could provide a considerable contribution in the treatment field for youth with co-occurring substance use and internalizing disorders.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPT-A
Arm Type
Experimental
Arm Description
OPT-A is an outpatient family-based treatment for co-occurring substance use and internalizing disorders
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment as usual in a community based mental health center
Intervention Type
Behavioral
Intervention Name(s)
OutPatient Treatment for Adolescents (OPT-A)
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual
Primary Outcome Measure Information:
Title
Substance use
Time Frame
baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up
Title
Mental Health
Time Frame
baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 10 to 17 years of age Residing with at least one adult caregiver who serves as a parent figure In need of treatment for a Substance Abuse or Dependence Disorder In need of treatment for an Axis I Mood Disorder and/or Anxiety Disorder Exclusion Criteria: Pervasive Developmental Disorder Active Psychotic Disorder Severe or profound mental retardation
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
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

Learn more about this trial

Research on Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders

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