NCT01922297

Brief Summary

This study will determine the clinical effectiveness, moderators and mechanisms of change, and economic impact of an integrative, family-based intervention that concurrently targets change in HIV/Sexually Transmitted Disease (STD)-associated risk behaviors, drug abuse, delinquency, arrest and mental health outcomes for juvenile offenders committed to a juvenile justice day treatment program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

5.2 years

First QC Date

August 10, 2013

Last Update Submit

August 21, 2015

Conditions

Keywords

DelinquencyHIV Associated Risk BehaviorJuvenilesFamily based treatmentMultidimensional Family Therapy

Outcome Measures

Primary Outcomes (1)

  • Substance Use

    The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use

    Changes in substance use from intake through the 24-month follow-up

Secondary Outcomes (2)

  • HIV Associated Sexual Risk Behaviors

    Changes in HIV Associated Sexual Risk Behaviors from intake to the 24-month follow-up

  • Delinquency

    Changes in delinquency from intake through the 24-month follow-up

Study Arms (2)

Day Treatment MDFT-HIV

EXPERIMENTAL

Multidimensional Family Therapy (MDFT)is an integrative treatment approach that has blended family therapy, individual therapy, drug counseling, and multiple systems oriented intervention approaches (Liddle 1999). DT-MDFT-HIV includes a state-of-the-art family-based HIV prevention component into the core MDFT intervention specifically targeting high-risk sexual behavior in clinical sample teens.

Other: Day Treatment MDFT-HIV

Day Treatment SAU

OTHER

The DT-Services as Usual (SAU) condition is primarily a peer group-based and individual approach that uses cognitive-behavioral principles and interventions. It is an adolescent substance abuse treatment and services consistent with those recommended for juvenile justice-involved drug abusing youth (Cooper \& Bartlett 1998; National Institute of Justice, 2001).

Other: Day Treatment SAU

Interventions

MDFT-HIV is a specialized intervention aimed at reducing risk factors for HIV-associated sexual behaviors. It builds protective behaviors in the adolescent's intrapersonal and interpersonal functioning, as well as those aspects of family functioning to reduce youths' high-risk sexual behavior. For instance, interventions target inadequate monitoring, parent-adolescent conflict, and parental disengagement - behaviors consistently associated with elevated HIV/STD risk. It facilitates positive and supportive family relationships, processes that can significantly reduce HIV/STD risk. Additionally, it aims to promote effective family communication about sexuality and safer sexual behaviors, among the most important protective factors against sexual risk taking behavior.

Also known as: DT-MDFT-HIV
Day Treatment MDFT-HIV

Substance abuse treatment and HIV prevention services are routinely provided to youth in the day treatment programs. The day treatment programs contract to local substance abuse and mental health providers for these services that are provided both within and outside of the day treatment setting. The intervention's specific features are similar to those found in the literature on outpatient peer-based group treatment for adolescent alcohol abusers (CSAT 1998). Specifically, it is based on a cognitive-behavioral group treatment model (Kaminer et al 1998; Marshall \& Marshall 1993), with a comprehensive treatment package including individual counseling and treatment planning.

Also known as: DT-SAU
Day Treatment SAU

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Between the ages of 13 and 18
  • Committed to a juvenile justice day treatment program
  • Meet criteria for substance use disorder on the DISC Predictive Scales
  • Any self-reported sexual activity within the past 6 months
  • At least one parent figure willing to participate in intervention and assessments

You may not qualify if:

  • Mental retardation or pervasive developmental disorders
  • Psychotic features
  • Current suicidality defined as Ideation + Plan + High intention to carry out plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Risk-TakingSubstance-Related Disorders

Condition Hierarchy (Ancestors)

BehaviorChemically-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

August 10, 2013

First Posted

August 14, 2013

Study Start

January 1, 2010

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations