Family-based and Adolescent Residential Drug Treatment (ART)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Howard Liddle, University of Miami
ClinicalTrials.gov Identifier:
NCT01737632
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Substance Use
Delinquency
Behavioral: Multidimensional Family Therapy (MDFT)
Behavioral: Adolescent Residential Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family-Based Versus Adolescent Residential Drug Treatment

Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Change in Personal Involvement with Chemicals [ Time Frame: Baseline, 2, 4, 12, 18, 24, 36 and 48 months after baseline ] [ Designated as safety issue: No ]
    Scale from the Personal Experience Inventory (PEI) developed by Ken Winter.

  • Change in substance use consumption [ Time Frame: Baseline, 2, 4, 12,18,24,36,48 months after intake ] [ Designated as safety issue: No ]
    Measure of substance use consumption as measured by the Timeline Follow-back Method.

  • Change in externalizing symptoms [ Time Frame: Baseline, 2, 4, 12, 18, 24, 36 and 48 months ] [ Designated as safety issue: No ]
    Externalizing symptoms measured by the Youth Self Report

  • Change in delinquency [ Time Frame: Intake, 2, 4, 12, 18, 24, 35, 48 months after intake ] [ Designated as safety issue: No ]
    Measured by youth report on the Self Report Delinquency Scale.

  • Change in internalzing symptoms [ Time Frame: Intake, 2, 4, 12, 18, 24, 36, 48 months after baseline ] [ Designated as safety issue: No ]
    Measured by the Youth Self Report (YSR)


Secondary Outcome Measures:
  • Change in family conflict [ Time Frame: Baseline, 2, 4, 12, 18, 24, 36, 48 months after baseline ] [ Designated as safety issue: No ]
    Parent and youth report on their family conflict as measured by the Family Environment Scale.

  • Change in parenting practices [ Time Frame: Baseline, 2, 4, 12, 18, 24,36, 48 months after baseline ] [ Designated as safety issue: No ]
    Measures the extent to which parents monitor, set limits, and provide affection to their teens.

  • Change in family cohesion [ Time Frame: Intake, 2, 4, 12, 18, 24, 26, 48 months after intake ] [ Designated as safety issue: No ]
    Youth and parent reports of family closeness measured by the Family Environment Scale (FES)


Enrollment: 113
Study Start Date: August 2000
Study Completion Date: June 2010
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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 (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.
Behavioral: 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.

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?

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01737632

Locations
United States, Florida
The Village, Inc.
Miami, Florida, United States, 33137
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Howard A Liddle, EdD University of Miami
  More Information

Publications:
Responsible Party: Howard Liddle, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT01737632     History of Changes
Other Study ID Numbers: P50 DA11328
Study First Received: November 20, 2012
Last Updated: November 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Adolescents
Residential Treatment
Outpatient Treatment
Substance Abuse
Delinquency
Family Therapy
Multidimensional Family therapy

ClinicalTrials.gov processed this record on October 23, 2014