- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01737632
Family-based and Adolescent Residential Drug Treatment (ART)
Family-Based Versus Adolescent Residential Drug Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Miami, Florida, United States, 33136
- University of Miami Miller School of Medicine
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Miami, Florida, United States, 33137
- The Village, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Multidimensional Family Therapy (MDFT)
MDFT is an intensive, in-home family-based drug abuse treatment for adolescent substance abusers.
MDFT views family factors in their context -in terms of the network (individual, familial, peer, community) or multiplicity of influences on drug use and change.
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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.
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Other: Adolescent Residential Treatment
The Adolescent Treatment Program (ATP) is a residential dual diagnosed substance abuse treatment program that is staff secure.
It is based on a social learning approach which emphasizes positive reinforcement for appropriate coping behavior and social skills, and incorporates a "levels" system which allocates privileges and responsibilities according to the individual's behavioral capacities.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Personal Involvement with Chemicals
Time Frame: Baseline, 2, 4, 12, 18, 24, 36 and 48 months after baseline
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Scale from the Personal Experience Inventory (PEI) developed by Ken Winter.
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Baseline, 2, 4, 12, 18, 24, 36 and 48 months after baseline
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Change in substance use consumption
Time Frame: Baseline, 2, 4, 12,18,24,36,48 months after intake
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Measure of substance use consumption as measured by the Timeline Follow-back Method.
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Baseline, 2, 4, 12,18,24,36,48 months after intake
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Change in externalizing symptoms
Time Frame: Baseline, 2, 4, 12, 18, 24, 36 and 48 months
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Externalizing symptoms measured by the Youth Self Report
|
Baseline, 2, 4, 12, 18, 24, 36 and 48 months
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Change in delinquency
Time Frame: Intake, 2, 4, 12, 18, 24, 35, 48 months after intake
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Measured by youth report on the Self Report Delinquency Scale.
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Intake, 2, 4, 12, 18, 24, 35, 48 months after intake
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Change in internalzing symptoms
Time Frame: Intake, 2, 4, 12, 18, 24, 36, 48 months after baseline
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Measured by the Youth Self Report (YSR)
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Intake, 2, 4, 12, 18, 24, 36, 48 months after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in family conflict
Time Frame: Baseline, 2, 4, 12, 18, 24, 36, 48 months after baseline
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Parent and youth report on their family conflict as measured by the Family Environment Scale.
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Baseline, 2, 4, 12, 18, 24, 36, 48 months after baseline
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Change in parenting practices
Time Frame: Baseline, 2, 4, 12, 18, 24,36, 48 months after baseline
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Measures the extent to which parents monitor, set limits, and provide affection to their teens.
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Baseline, 2, 4, 12, 18, 24,36, 48 months after baseline
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Change in family cohesion
Time Frame: Intake, 2, 4, 12, 18, 24, 26, 48 months after intake
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Youth and parent reports of family closeness measured by the Family Environment Scale (FES)
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Intake, 2, 4, 12, 18, 24, 26, 48 months after intake
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Howard A Liddle, EdD, University of Miami
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P50DA011328 (U.S. NIH Grant/Contract)
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