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

NCT ID: NCT01117753

Last Updated: 2015-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Substance-Related Disorders Depressive Disorder Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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OPT-A

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

Group Type EXPERIMENTAL

OutPatient Treatment for Adolescents (OPT-A)

Intervention Type BEHAVIORAL

Treatment as Usual

Treatment as usual in a community based mental health center

Group Type ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type BEHAVIORAL

Interventions

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OutPatient Treatment for Adolescents (OPT-A)

Intervention Type BEHAVIORAL

Treatment As Usual

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ashli J Sheidow, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DA025616-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MUSC19301

Identifier Type: -

Identifier Source: org_study_id

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