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

Depressive Disorder Clinical Trial

Official title:

Stage II Research on Outpatient Treatment for Adolescents With Comorbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117753
• Other study ID #: MUSC19301
• Secondary ID: 1R01DA025616-01A
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2010
• Last updated: April 10, 2015
• Start date: July 2009
• Est. completion date: June 2014

Study information

• Verified date: May 2013
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depression
• Depressive Disorder
• Disease
• Substance-Related Disorders

Intervention

Behavioral:
• OutPatient Treatment for Adolescents (OPT-A)

• Treatment As Usual

Locations

Country	Name	City	State
United States	Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance use		baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up	No
Primary	Mental Health		baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up	No

External Links

•   Family Services Research Center Webpage