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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01737632
Other study ID # P50DA011328
Secondary ID
Status Completed
Phase N/A
First received November 20, 2012
Last updated November 26, 2012
Start date August 2000
Est. completion date June 2010

Study information

Verified date November 2012
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The fundamental objective of this study is to compare the effectiveness of an intensive in-home family-based treatment, Multidimensional Family Therapy, with a multifaceted residential treatment, Adolescent Residential Treatment, over 4 years post-intake and to delineate the mechanisms of change for each treatment. The study targets dually- diagnosed adolescent drug abusers recommended for residential treatment.


Description:

Aim 1: To compare the effectiveness of residential treatment with outpatient, family-based treatment multiple outcomes including substance use, mental health, school functioning, family function and delinquency among dually diagnosed adolescents.

Hypothesis 1. From intake to 2 months, residential treatment will show better outcomes than the family based treatment. Between 2 months and 18 months, family based treatment will show better outcomes than residential. Between 18 months and four years post intake, outpatient family based treatment will maintain its treatment gains, while the residential treatment condition will show an increase in these same symptoms and behaviors.

Aim 2: To examine the relationship between predictors (family, peer, educational/vocational functioning and involvement in post-treatment services), and outcomes (drug use, co-morbid symptoms, and criminal behavior) during the four-year post intake period.

Hypothesis 2a. Family functioning, educational/vocational functioning, and peer relationships measured at discharge will predict drug use, co-morbid symptoms, and criminal behaviors though the four year longer term follow up period.

Hypothesis 2b. Family functioning, educational/vocational functioning, peer relationships, and involvement in post-treatment services during the post treatment period will predict drug use, co-morbid symptoms, and criminal behavior through the longer term follow up period.

Research Question 1. Is the rate of change in family functioning, educational/vocational functioning, peer relationships, and involvement in post-treatment services related to the rate of change in drug use, co-morbid symptoms, and criminal behavior?


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date June 2010
Est. primary completion date June 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria:

- Youth between the ages of 13 and 17

- Referred to ATP for residential substance abuse treatment in youth dual diagnosis program

- Dually diagnosed for substance abuse or dependence and at least one of the following co-morbid conditions: major depressive disorder, bipolar disorder, I conduct disorder, oppositional defiant disorder,

- At least one parent or parent-figure can be located at the time of referral.

- Obtain informed consent from a parent or formal guardian and assent from youth to participate in the study.

Exclusion Criteria:

- Have any of the following disorders: Mental Retardation, Eating Disorders, Schizophrenia, or Pervasive Developmental Disorders.

- Current suicidality.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Multidimensional Family Therapy (MDFT)
MDFT assesses and intervenes in five domains: 1) Interventions with the adolescent, 2) interventions with the parent, 3) interventions to improve the parent-adolescent relationship, 4) interventions with other family members, and 5) interventions with external systems.
Adolescent Residential Treatment
The Adolescent Treatment Program targets the adolescent's abuse or dependency on chemicals while simultaneously treating the comorbid symptomatology found in dual diagnosed patients. These goals are accomplished by using four primary forms of intervention: (1) Chemical Education; (2) Group, Individual and Family Counseling; (3) Twelve Step Work; and 4) Psychotropic Medication for Clinical Symptomatology Comorbid with Substance Abuse.

Locations

Country Name City State
United States The Village, Inc. Miami Florida
United States University of Miami Miller School of Medicine Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zavala SK, French MT, Henderson CE, Alberga L, Rowe C, Liddle HA. Guidelines and challenges for estimating the economic costs and benefits of adolescent substance abuse treatments. J Subst Abuse Treat. 2005 Oct;29(3):191-205. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Personal Involvement with Chemicals Scale from the Personal Experience Inventory (PEI) developed by Ken Winter. Baseline, 2, 4, 12, 18, 24, 36 and 48 months after baseline No
Primary Change in substance use consumption Measure of substance use consumption as measured by the Timeline Follow-back Method. Baseline, 2, 4, 12,18,24,36,48 months after intake No
Primary Change in externalizing symptoms Externalizing symptoms measured by the Youth Self Report Baseline, 2, 4, 12, 18, 24, 36 and 48 months No
Primary Change in delinquency Measured by youth report on the Self Report Delinquency Scale. Intake, 2, 4, 12, 18, 24, 35, 48 months after intake No
Primary Change in internalzing symptoms Measured by the Youth Self Report (YSR) Intake, 2, 4, 12, 18, 24, 36, 48 months after baseline No
Secondary Change in family conflict Parent and youth report on their family conflict as measured by the Family Environment Scale. Baseline, 2, 4, 12, 18, 24, 36, 48 months after baseline No
Secondary Change in parenting practices Measures the extent to which parents monitor, set limits, and provide affection to their teens. Baseline, 2, 4, 12, 18, 24,36, 48 months after baseline No
Secondary Change in family cohesion Youth and parent reports of family closeness measured by the Family Environment Scale (FES) Intake, 2, 4, 12, 18, 24, 26, 48 months after intake No
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