NCT01737632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

Enrollment Period

7.8 years

First QC Date

November 20, 2012

Last Update Submit

November 26, 2012

Conditions

Keywords

AdolescentsResidential TreatmentOutpatient TreatmentSubstance AbuseDelinquencyFamily TherapyMultidimensional Family therapy

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • Change in externalizing symptoms

    Externalizing symptoms measured by the Youth Self Report

    Baseline, 2, 4, 12, 18, 24, 36 and 48 months

  • Change in delinquency

    Measured by youth report on the Self Report Delinquency Scale.

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

  • Change in internalzing symptoms

    Measured by the Youth Self Report (YSR)

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

Secondary Outcomes (3)

  • Change in family conflict

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

  • Change in parenting practices

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

  • Change in family cohesion

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

Study Arms (2)

Multidimensional Family Therapy (MDFT)

EXPERIMENTAL

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)

Adolescent Residential Treatment

OTHER

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

Interventions

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.

Multidimensional Family Therapy (MDFT)

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.

Adolescent Residential Treatment

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

The Village, Inc.

Miami, Florida, 33137, United States

Location

Related 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. doi: 10.1016/j.jsat.2005.06.004.

    PMID: 16183468BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Howard A Liddle, EdD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 29, 2012

Study Start

August 1, 2000

Primary Completion

June 1, 2008

Study Completion

June 1, 2010

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations