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

21 de agosto de 2015 actualizado por: Howard Liddle, University of Miami
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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

121

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Florida
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami Miller School of Medicine

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

13 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Day Treatment MDFT-HIV
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.
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.
Otros nombres:
  • DT-MDFT-HIV
Otro: Day Treatment SAU
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).
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.
Otros nombres:
  • DT-SAU

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Substance Use
Periodo de tiempo: Changes in substance use from intake through the 24-month follow-up
The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use
Changes in substance use from intake through the 24-month follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
HIV Associated Sexual Risk Behaviors
Periodo de tiempo: Changes in HIV Associated Sexual Risk Behaviors from intake to the 24-month follow-up
Timeline Followback for Sexual Risk Behavior, Urinalysis for STD testing and HIV/STD Risk Assessment Measure
Changes in HIV Associated Sexual Risk Behaviors from intake to the 24-month follow-up
Delinquency
Periodo de tiempo: Changes in delinquency from intake through the 24-month follow-up
Juvenile Justice records and the Service Utilization Interview
Changes in delinquency from intake through the 24-month follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Howard A Liddle, EdD, University of Miami

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2010

Finalización primaria (Actual)

1 de abril de 2015

Finalización del estudio (Actual)

1 de abril de 2015

Fechas de registro del estudio

Enviado por primera vez

10 de agosto de 2013

Primero enviado que cumplió con los criterios de control de calidad

13 de agosto de 2013

Publicado por primera vez (Estimar)

14 de agosto de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

25 de agosto de 2015

Última actualización enviada que cumplió con los criterios de control de calidad

21 de agosto de 2015

Última verificación

1 de agosto de 2015

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 20090438
  • R01DA027216 (Subvención/contrato del NIH de EE. UU.)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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