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Completed

NCT Number: NCT01737632

Family-based and Adolescent Residential Drug Treatment

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.

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Key information

Conditions

Substance Use Chemically-Induced Disorders Delinquency Mental Disorders Substance-Related Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Village, Inc., Miami, Florida, United States

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About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multidimensional Family Therapy (MDFT)

Behavioral

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

Behavioral

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 outcomes

  1. Change in Personal Involvement with Chemicals

    Time frame: Baseline, 2, 4, 12, 18, 24, 36 and 48 months after baseline

    Scale from the Personal Experience Inventory (PEI) developed by Ken Winter.

  2. Change in substance use consumption

    Time frame: Baseline, 2, 4, 12,18,24,36,48 months after intake

    Measure of substance use consumption as measured by the Timeline Follow-back Method.

  3. Change in externalizing symptoms

    Time frame: Baseline, 2, 4, 12, 18, 24, 36 and 48 months

    Externalizing symptoms measured by the Youth Self Report

  4. Change in delinquency

    Time frame: Intake, 2, 4, 12, 18, 24, 35, 48 months after intake

    Measured by youth report on the Self Report Delinquency Scale.

  5. Change in internalzing symptoms

    Time frame: Intake, 2, 4, 12, 18, 24, 36, 48 months after baseline

    Measured by the Youth Self Report (YSR)

Secondary outcomes

  1. Change in family conflict

    Time frame: Baseline, 2, 4, 12, 18, 24, 36, 48 months after baseline

    Parent and youth report on their family conflict as measured by the Family Environment Scale.

  2. Change in parenting practices

    Time frame: Baseline, 2, 4, 12, 18, 24,36, 48 months after baseline

    Measures the extent to which parents monitor, set limits, and provide affection to their teens.

  3. Change in family cohesion

    Time frame: Intake, 2, 4, 12, 18, 24, 26, 48 months after intake

    Youth and parent reports of family closeness measured by the Family Environment Scale (FES)

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Family-Based Versus Adolescent Residential Drug Treatment

Acronym: ART

Important dates

Study start
2000
Primary completion
2008
Study completion
2010
First posted
Nov 29, 2012
Registry last updated
Nov 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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