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Juvenile Offender HIV Prevention and Drug Abuse Services (Day Treatment)

Primary Purpose

Risk Behavior, Substance Abuse, Delinquency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Day Treatment MDFT-HIV
Day Treatment SAU
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Risk Behavior focused on measuring Delinquency, HIV Associated Risk Behavior, Juveniles, Family based treatment, Multidimensional Family Therapy

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University of Miami Miller School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Day Treatment MDFT-HIV

Day Treatment SAU

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HIV Associated Sexual Risk Behaviors
Timeline Followback for Sexual Risk Behavior, Urinalysis for STD testing and HIV/STD Risk Assessment Measure
Delinquency
Juvenile Justice records and the Service Utilization Interview

Full Information

First Posted
August 10, 2013
Last Updated
August 21, 2015
Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01922297
Brief Title
Juvenile Offender HIV Prevention and Drug Abuse Services
Acronym
Day Treatment
Official Title
Juvenile Offender HIV Prevention and Drug Abuse Services
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Adolescents committed to three school-based day treatment programs located in Miami-Dade County will be randomized to either Day Treatment MDFT-HIV (DT-MDFT-HIV) or Day Treatment Program Services as Usual (DT-SAU). Youth in both conditions will be enrolled in day treatment, and receive the same type of juvenile justice supervision, participate in the same educational, life skills, vocational and recreational programs. They will only differ in the type of substance abuse treatment and HIV prevention services received, DT-MDFT-HIV versus substance abuse and HIV prevention services currently being provided by the day treatment programs. If participants are eligible, they will then be assessed on multiple measures at 5 time points: intake, 3, 6, 12, and 24 months following commitment to the day treatment facility. Data will be analyzed using an intent-to-treat design - adolescents and one parent are assessed at all time points and included in data analyses, regardless of the amount of treatment received. The study has three aims: Aim 1: Intervention Effectiveness - To experimentally compare, in a day treatment setting, the short and long-term clinical outcomes of the Experimental Intervention - MDFT-HIV Integrated intervention (DT-MDFT-HIV) for sexually active drug abusing juvenile offenders with Day Treatment Services as Usual (DT-SAU). Hypothesis 1a. Youths assigned to DT-MDFT-HIV will show a greater decrease in HIV-associated sexual risk behaviors, laboratory-confirmed STD incidence, drug use, arrests and out of home placements, and mental health symptoms from baseline assessment through 6 months post-baseline than youths in SAU. Hypothesis 1b. Youths assigned to DT-MDFT-HIV will show a greater decrease in HIV-associated sexual risk behaviors, laboratory-confirmed STD incidence, drug use, arrests and out of home placements, and mental health symptoms from 6 months post baseline to 24 months post-baseline than youths in SAU. Hypothesis 1c. Youths assigned to DT-MDFT-HIV will be more likely to successfully transition out of the juvenile justice day treatment program--and return to regular school placement--than those assigned to services as usual. Aim 2: Moderating Effects - To identify baseline client characteristics that moderate intervention outcomes. Hypothesis 2. For youths with high baseline levels of co-morbidity, HIV-associated sexual risk behaviors, drug use and delinquency, the DT-MDFT-HIV intervention will reduce HIV-associated sexual risk behaviors and laboratory-confirmed STD incidence, drug use, and arrests and out of home placements more significantly than the DT-SAU condition. For youths with low baseline levels of HIV-associated sexual risk behaviors, drug use and delinquency, the two interventions will be comparably effective. Aim 3: Mechanisms of Action - To identify the mechanisms through which the experimental intervention achieves its effects. Hypothesis 3a. For youths assigned to DT-MDFT-HIV, reductions in HIV-associated sexual risk behaviors and laboratory-confirmed STD incidence will be achieved through (a) increases in HIV/STD knowledge and risk-reduction skills, (b) enhanced self-efficacy regarding condom use, (c) improved communication and refusal skills with partners, (d) greater perceived peer norms supportive of safer sex, (e) open communication with parents about HIV and sexual risk behaviors, and (f) more effective parenting and improved family functioning. Hypothesis 3b. For youths assigned to DT-MDFT-HIV, reductions in drug use and delinquency will be achieved through (a) increases in adolescents' bonding to prosocial peers and activities (e.g. school), (b) increases in parents' emotional bonding to their adolescent, and improvements in parenting practices, and (c) more positive family environment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk Behavior, Substance Abuse, Delinquency
Keywords
Delinquency, HIV Associated Risk Behavior, Juveniles, Family based treatment, Multidimensional Family Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Day Treatment MDFT-HIV
Arm Type
Experimental
Arm Description
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.
Arm Title
Day Treatment SAU
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Day Treatment MDFT-HIV
Other Intervention Name(s)
DT-MDFT-HIV
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Day Treatment SAU
Other Intervention Name(s)
DT-SAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Substance Use
Description
The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use
Time Frame
Changes in substance use from intake through the 24-month follow-up
Secondary Outcome Measure Information:
Title
HIV Associated Sexual Risk Behaviors
Description
Timeline Followback for Sexual Risk Behavior, Urinalysis for STD testing and HIV/STD Risk Assessment Measure
Time Frame
Changes in HIV Associated Sexual Risk Behaviors from intake to the 24-month follow-up
Title
Delinquency
Description
Juvenile Justice records and the Service Utilization Interview
Time Frame
Changes in delinquency from intake through the 24-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Mental retardation or pervasive developmental disorders Psychotic features Current suicidality defined as Ideation + Plan + High intention to carry out plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard A Liddle, EdD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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Juvenile Offender HIV Prevention and Drug Abuse Services

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