Clinical trial NCT01922297: Juvenile Offender HIV Prevention and Drug Abuse Services
Official title: Juvenile Offender HIV Prevention and Drug Abuse Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Risk Behavior
Substance Abuse
Delinquency
Keywords: Delinquency
HIV Associated Risk Behavior
Juveniles
Family based treatment
Multidimensional Family Therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-08-14
Enrollment: 121
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Substance Use
timeFrame: Changes in substance use from intake through the 24-month follow-up
Secondary outcomes:
measure: HIV Associated Sexual Risk Behaviors
timeFrame: Changes in HIV Associated Sexual Risk Behaviors from intake to the 24-month follow-up
measure: Delinquency
timeFrame: Changes in delinquency from intake through the 24-month follow-up
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Howard A Liddle, EdD
role: PRINCIPAL_INVESTIGATOR
References: