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OpenTrials
Completed

NCT Number: NCT01117753

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

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.

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OutPatient Treatment for Adolescents (OPT-A)

Behavioral

Treatment as Usual

Behavioral

Primary outcomes

  1. Substance use

    Time frame: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up

  2. Mental Health

    Time frame: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Stage II Research on Outpatient Treatment for Adolescents With Comorbidity

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
May 5, 2010
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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