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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01117753
First received: May 4, 2010
Last updated: May 21, 2013
Last verified: May 2013
  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 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.


Condition Intervention Phase
Substance-Related Disorders
Depressive Disorder
Anxiety Disorder
Behavioral: OutPatient Treatment for Adolescents (OPT-A)
Behavioral: Treatment As Usual
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stage II Research on Outpatient Treatment for Adolescents With Comorbidity

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Substance use [ Time Frame: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up ] [ Designated as safety issue: No ]
  • Mental Health [ Time Frame: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPT-A
OPT-A is an outpatient family-based treatment for co-occurring substance use and internalizing disorders
Behavioral: OutPatient Treatment for Adolescents (OPT-A)
Active Comparator: Treatment as Usual
Treatment as usual in a community based mental health center
Behavioral: Treatment As Usual

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01117753

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
  More Information

Additional Information:
No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01117753     History of Changes
Other Study ID Numbers: MUSC19301, 1R01DA025616-01A1
Study First Received: May 4, 2010
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

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 22, 2014