Juvenile Detention to Community Life

Substance Use Clinical Trial

— DTC  

Official title:

Facilitating Adolescent Offenders' Reintegration From Juvenile Detention to Community Life (DTC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910324
• Other study ID #: 20043161
• Status: Completed
• Phase: N/A
• First received: July 25, 2013
• Last updated: May 21, 2014
• Start date: April 2006
• Est. completion date: December 2011

Study information

• Verified date: May 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2011
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delinquency
• Risk for HIV Infection
• Substance Use

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Pinellas Juvenile Detention Center	Clearwater	Florida
United States	Operation PAR Inc.	Largo	Florida
United States	Here's Help, Inc.	Miami	Florida
United States	Miami-Dade Juvenile Detention Center	Miami	Florida
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Delinquency	National Youth Survey Self-Report Delinquency Scale and the Juvenile/Criminal Justice records will be used to measure delinquency	Release from detention through the 42-month follow-up	No
Secondary	Sexual Risk Behaviors	Timeline Followback of Sexual Risk Behaviors, Urine Analyses for Sexually Transmitted Diseases (STDs) and HIV Testing.	Release from detention through the 42-month follow-up	No