NCT01910324

Brief Summary

The fundamental objective of the proposed study is to develop and test an innovative two-stage, cross-systems family-based intervention for substance abusing juvenile offenders. The first stage of the experimental treatment is provided for youths in juvenile detention settings. Stage two of the intervention occurs after the offender is released to the community. Participants are randomized to one of two study conditions: the cross-systems family-based intervention (Multidimensional Family Therapy-Cross Systems (MDFT-CS), or 2) Enhanced Services as Usual (ESAU). Both conditions incorporate HIV prevention in detention and we will also examine the effects of a family-based HIV/STD prevention module beyond the impact of a standard HIV/STD education intervention delivered in detention by including ongoing HIV/STD intervention in MDFT-CS following release from detention. There are five aims of the proposed study. These aims relate to: 1) Intervention development and implementation; 2) Clinical effectiveness; 3) Impact of HIV/AIDS/STD prevention; 4) Comparative benefit-costs; and 5) Systems-level impact

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

5 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

April 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2013

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

2.4 years

First QC Date

July 25, 2013

Last Update Submit

May 21, 2014

Conditions

Substance UseDelinquencyRisk for HIV Infection

Keywords

Juvenile OffendersHIV/STD PreventionAdolescent Substance AbuseMultidimensional Family Therapy

Outcome Measures

Primary Outcomes (1)

  • Substance use

    Timeline Follow-Back Method of Drug and Alcohol Use, Urine analyses for Drug Use, Personal Experiences Inventory and the Adolescent Diagnostic Interview-Light will be used to measure substance use.

    Release from detention through the 42-month follow-up

Secondary Outcomes (2)

  • Delinquency

    Release from detention through the 42-month follow-up

  • Sexual Risk Behaviors

    Release from detention through the 42-month follow-up

Study Arms (2)

Multidimensional Family Therapy Cross-Systems

EXPERIMENTAL

In Stage 1 (in detention) Multidimensional Family Therapy Cross-Systems (MDFT-CS) consists of two major components: standard initial/engagement work with parents in the home and with adolescents in detention, plus a state-of-the-art HIV education prevention module. In Stage 2, MDFT-CS includes the standard MDFT components: 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.

Behavioral: Multidimensional Family Therapy Cross-Systems

Enhanced Services as Usual

OTHER

In Stage 1 (in detention) ESAU includes two major components: standard drug treatment services delivered by detention staff, and state-of-the-art HIV education prevention intervention. In Stage 2, community drug treatment providers deliver high quality drug treatment on an outpatient basis.

Behavioral: Enhanced Services as Usual

Interventions

Multidimensional Family Therapy Cross-SystemsBEHAVIORAL

Standard initial/engagement work in the home and detention, plus a state-of-the-art HIV education prevention module as well as standard MDFT which 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.

Also known as: MDFT-CS
Multidimensional Family Therapy Cross-Systems
Enhanced Services as UsualBEHAVIORAL

Standard drug treatment services in detention and state-of-the-art HIV education prevention intervention, as well as outpatient drug treatment provided by community drug treatment providers

Also known as: ESAU
Enhanced Services as Usual

Eligibility Criteria

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

You may qualify if:

  • Be between the ages of 13 and 17
  • Be incarcerated in a juvenile detention facility at intake
  • Endorse substance abuse problems on the MAYSI or other intake forms
  • Have at least one parent figure willing/able to participate in the intervention and research assessments
  • Provide informed consent to participate in the study

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
  • High risk to receive long-term residential placement directly from detention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pinellas Juvenile Detention Center

Clearwater, Florida, 33760, United States

Location

Operation PAR Inc.

Largo, Florida, 33771, United States

Location

Here's Help, Inc.

Miami, Florida, 33054, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Miami-Dade Juvenile Detention Center

Miami, Florida, 33142, United States

Location

Related Publications (4)

  • Liddle HA, Dakof GA, Henderson C, Rowe C. Implementation outcomes of Multidimensional Family Therapy-Detention to Community: a reintegration program for drug-using juvenile detainees. Int J Offender Ther Comp Criminol. 2011 Jun;55(4):587-604. doi: 10.1177/0306624X10366960. Epub 2010 Apr 28.

    PMID: 20427547BACKGROUND

  • Marvel F, Rowe CL, Colon-Perez L, DiClemente RJ, Liddle HA. Multidimensional family therapy HIV/STD risk-reduction intervention: an integrative family-based model for drug-involved juvenile offenders. Fam Process. 2009 Mar;48(1):69-84. doi: 10.1111/j.1545-5300.2009.01268.x.

    PMID: 19378646BACKGROUND

  • Rowe CL, Wang W, Greenbaum P, Liddle HA. Predicting HIV/STD risk level and substance use disorders among incarcerated adolescents. J Psychoactive Drugs. 2008 Dec;40(4):503-12. doi: 10.1080/02791072.2008.10400656.

    PMID: 19283954BACKGROUND

  • Rowe CL, Alberga L, Dakof GA, Henderson CE, Ungaro R, Liddle HA. Family-Based HIV and Sexually Transmitted Infection Risk Reduction for Drug-Involved Young Offenders: 42-Month Outcomes. Fam Process. 2016 Jun;55(2):305-20. doi: 10.1111/famp.12206. Epub 2016 Feb 16.

    PMID: 26879671DERIVED

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
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2013

First Posted

July 29, 2013

Study Start

April 1, 2006

Primary Completion

September 1, 2008

Study Completion

December 1, 2011

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations

US(5)