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Family-based and Adolescent Residential Drug Treatment (ART)

Primary Purpose

Substance Use, Delinquency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multidimensional Family Therapy (MDFT)
Adolescent Residential Treatment
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use focused on measuring Adolescents, Residential Treatment, Outpatient Treatment, Substance Abuse, Delinquency, Family Therapy, Multidimensional Family therapy

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Miami Miller School of Medicine
  • The Village, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Multidimensional Family Therapy (MDFT)

Adolescent Residential Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Personal Involvement with Chemicals
Scale from the Personal Experience Inventory (PEI) developed by Ken Winter.
Change in substance use consumption
Measure of substance use consumption as measured by the Timeline Follow-back Method.
Change in externalizing symptoms
Externalizing symptoms measured by the Youth Self Report
Change in delinquency
Measured by youth report on the Self Report Delinquency Scale.
Change in internalzing symptoms
Measured by the Youth Self Report (YSR)

Secondary Outcome Measures

Change in family conflict
Parent and youth report on their family conflict as measured by the Family Environment Scale.
Change in parenting practices
Measures the extent to which parents monitor, set limits, and provide affection to their teens.
Change in family cohesion
Youth and parent reports of family closeness measured by the Family Environment Scale (FES)

Full Information

First Posted
November 20, 2012
Last Updated
November 26, 2012
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT01737632
Brief Title
Family-based and Adolescent Residential Drug Treatment
Acronym
ART
Official Title
Family-Based Versus Adolescent Residential Drug Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Delinquency
Keywords
Adolescents, Residential Treatment, Outpatient Treatment, Substance Abuse, Delinquency, Family Therapy, Multidimensional Family therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidimensional Family Therapy (MDFT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Adolescent Residential Treatment
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multidimensional Family Therapy (MDFT)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Adolescent Residential Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Personal Involvement with Chemicals
Description
Scale from the Personal Experience Inventory (PEI) developed by Ken Winter.
Time Frame
Baseline, 2, 4, 12, 18, 24, 36 and 48 months after baseline
Title
Change in substance use consumption
Description
Measure of substance use consumption as measured by the Timeline Follow-back Method.
Time Frame
Baseline, 2, 4, 12,18,24,36,48 months after intake
Title
Change in externalizing symptoms
Description
Externalizing symptoms measured by the Youth Self Report
Time Frame
Baseline, 2, 4, 12, 18, 24, 36 and 48 months
Title
Change in delinquency
Description
Measured by youth report on the Self Report Delinquency Scale.
Time Frame
Intake, 2, 4, 12, 18, 24, 35, 48 months after intake
Title
Change in internalzing symptoms
Description
Measured by the Youth Self Report (YSR)
Time Frame
Intake, 2, 4, 12, 18, 24, 36, 48 months after baseline
Secondary Outcome Measure Information:
Title
Change in family conflict
Description
Parent and youth report on their family conflict as measured by the Family Environment Scale.
Time Frame
Baseline, 2, 4, 12, 18, 24, 36, 48 months after baseline
Title
Change in parenting practices
Description
Measures the extent to which parents monitor, set limits, and provide affection to their teens.
Time Frame
Baseline, 2, 4, 12, 18, 24,36, 48 months after baseline
Title
Change in family cohesion
Description
Youth and parent reports of family closeness measured by the Family Environment Scale (FES)
Time Frame
Intake, 2, 4, 12, 18, 24, 26, 48 months after intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard A Liddle, EdD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The Village, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16183468
Citation
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. doi: 10.1016/j.jsat.2005.06.004.
Results Reference
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Family-based and Adolescent Residential Drug Treatment

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