Juvenile Detention to Community Life (DTC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Howard Liddle, University of Miami
ClinicalTrials.gov Identifier:
NCT01910324
First received: July 25, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Substance Use
Delinquency
Risk for HIV Infection
Behavioral: Multidimensional Family Therapy Cross-Systems
Behavioral: Enhanced Services as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Facilitating Adolescent Offenders' Reintegration From Juvenile Detention to Community Life (DTC)

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Substance use [ Time Frame: Release from detention through the 42-month follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Delinquency [ Time Frame: Release from detention through the 42-month follow-up ] [ Designated as safety issue: No ]
    National Youth Survey Self-Report Delinquency Scale and the Juvenile/Criminal Justice records will be used to measure delinquency

  • Sexual Risk Behaviors [ Time Frame: Release from detention through the 42-month follow-up ] [ Designated as safety issue: No ]
    Timeline Followback of Sexual Risk Behaviors, Urine Analyses for Sexually Transmitted Diseases (STDs) and HIV Testing.


Enrollment: 154
Study Start Date: April 2006
Study Completion Date: December 2011
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multidimensional Family Therapy Cross-Systems
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
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.
Other Name: MDFT-CS
Enhanced Services as Usual
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
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
Other Name: ESAU

Detailed Description:

This study will employ a fully randomized (2 conditions) by 9 assessment points (baseline, discharge from detention, and 3, 6, 9, 18, 24, 36 and 42 months following detention discharge), repeated measures intent-to-treat design with multiple dependent variables. 154 males and females (85 participants from Miami Dade Regional Juvenile Detention Center and 85 from Pinellas Juvenile Detention Center) who meet the study eligibility criteria will be randomized to one of the two treatment conditions.

The study will also include a 6-month pilot phase. During this phase, the MDFT detention intervention and cross-systems collaboration protocols will be developed; the existing treatment manual will be revised; the MDFT-CS with family-based HIV prevention module and standard HIV education intervention will be developed; family therapists will be trained in the MDFT intervention (including HIV/STD module); the MDFT-CS intervention will be piloted; the assessment battery will be piloted; the protocols, manual, and training package will be revised and finalized; research staff will be trained on all procedures and protocols; and data management procedures will be developed.

During Stage 1, adolescents in all intervention conditions will receive standard detention services, which include education and health care. In addition, youth assigned to the ESAU condition will receive the standard mental health and substance abuse services offered in the detention (mainly psychoeducational in nature). Youth assigned to the MDFT-CS intervention will not receive standard mental health/substance abuse services provided by the detention center, as these youth will be assigned a MDFT therapist who will address their mental health and substance abuse issues needs.

Experimental Treatment: Multidimensional Family Therapy-Cross Systems (MDFT-CS). In Stage 1 (in detention) MDFT-CS, the experimental treatment, consists of two major components: standard initial/engagement work with parents in the home and with adolescents in detention (both conducted weekly for the duration of the adolescents stay in detention), plus a state-of-the-art HIV education prevention module based on CDC-endorsed strategies. The in-detention MDFT will be delivered by therapists employed by the University of Miami/ Center for Treatment Research on Adolescent Drug Abuse (CTRADA) who will continue to treat the youth and family after release from detention. In Stage 2, the experimental treatment includes the standard MDFT components (4 overall change units/targets: adolescent, parent, family interaction, and functioning of the family members vis a vis relevant extrafamilial social systems such as school and juvenile justice).

Enhanced Services as Usual (ESAU). In Stage 1 (in detention), ESAU includes two major components - standard drug treatment services that are delivered by detention staff, and state-of-the-art HIV education prevention intervention delivered to all participating youth.

In Stage 2, community drug treatment providers deliver high quality drug treatment on an outpatient basis. To minimize heterogeneity within the comparison condition, and in order to provide better service and treatment tracking opportunities, the study will only use one community based treatment agency to deliver ESAU per locale at each Research Center.

All measures selected are psychometrically strong, sensitive to change, and have been used widely in adolescent substance abuse treatment studies.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  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: NCT01910324

Locations
United States, Florida
Pinellas Juvenile Detention Center
Clearwater, Florida, United States, 33760
Operation PAR Inc.
Largo, Florida, United States, 33771
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Miami-Dade Juvenile Detention Center
Miami, Florida, United States, 33142
Here's Help, Inc.
Miami, Florida, United States, 33054
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: NCT01910324     History of Changes
Other Study ID Numbers: 20043161
Study First Received: July 25, 2013
Last Updated: May 21, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Miami:
Juvenile Offenders
HIV/STD Prevention
Adolescent Substance Abuse
Multidimensional Family Therapy

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014