NCT00438685

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 have worse outcomes and are more than twice as costly to treat than their counterparts with no comorbidity. This project was a pilot test of a new treatment, OPTION-A, which was adapted from Multisystemic Therapist (MST) and other evidence-based interventions to specifically treat youth presenting for outpatient treatment of comorbid substance use and internalizing disorders. The project was a randomized controlled pilot trial comparing the experimental treatment to usual services in the community.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 14, 2018

Status Verified

July 1, 2010

Enrollment Period

2.8 years

First QC Date

February 21, 2007

Last Update Submit

June 13, 2018

Conditions

Keywords

Substance-Related DisordersDepressive DisorderAnxiety DisorderAdolescentBehavior TherapyCognitive TherapyOutpatientsFamily RelationsSystems Theory

Outcome Measures

Primary Outcomes (2)

  • Urine Drug Screen at 4 weeks, 8 weeks, 12 weeks, 24 weeks

  • Score on Depression/Anxiety Scale (RCADS) at 4 weeks, 8 weeks, 12 weeks, 24 weeks

Secondary Outcomes (8)

  • Measured at Intake, 3 Months, and 6 Months

  • Global assessment of symptoms

  • Parenting

  • School

  • Behavioral

  • +3 more secondary outcomes

Interventions

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Presentation for outpatient treatment
  • to 17 years of age
  • Youth residing with at least one adult caregiver who serves as a parent figure
  • Substance Abuse or Dependence Disorder
  • Axis I Internalizing Disorder (Mood Disorder or Anxiety Disorder), based on the Diagnostic Interview Schedule for Children (DISC-IV; Shaffer, Fisher, Lucas, Dulcan, \& Schwab-Stone, 2000)

You may not qualify if:

  • Pervasive Developmental Disorder
  • Psychotic Disorder
  • Severe or profound mental retardation (IQ of 45 or below)
  • Families previously receiving Multisystemic Therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DisordersDepressive DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersMood Disorders

Study Officials

  • Ashli J Sheidow, PhD

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

    PRINCIPAL INVESTIGATOR
  • Scott W Henggeler, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 22, 2007

Study Start

October 1, 2004

Primary Completion

August 1, 2007

Study Completion

September 1, 2010

Last Updated

June 14, 2018

Record last verified: 2010-07

Locations