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

NCT01117753 | Completed Phase 2 DMC

• 2 other identifiers: MUSC193011R01DA025616-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders; Depressive Disorder; Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• Substance use

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

• Mental Health

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

Study Arms (2)

OPT-A

EXPERIMENTAL

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

Behavioral: OutPatient Treatment for Adolescents (OPT-A)

Treatment as Usual

ACTIVE COMPARATOR

Treatment as usual in a community based mental health center

Behavioral: Treatment As Usual

Interventions

OutPatient Treatment for Adolescents (OPT-A) BEHAVIORAL

OPT-A

Treatment As Usual BEHAVIORAL

Treatment as Usual

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

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

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Depressive Disorder; Anxiety Disorders

Interventions

Ambulatory Care; Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ashli J Sheidow, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 5, 2010
• Study Start: July 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 13, 2015

Record last verified: 2013-05

Locations

US (1)