Clinical trial NCT01117753: Research on Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders
Official title: Stage II Research on Outpatient Treatment for Adolescents With Comorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance-Related Disorders
Depressive Disorder
Anxiety Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-05-05
Enrollment: 140
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Substance use
timeFrame: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up
measure: Mental Health
timeFrame: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina, Department of Psychiatry & Behavioral Sciences, Family Services Research Center
name: Ashli J Sheidow, PhD
role: PRINCIPAL_INVESTIGATOR
References: