- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02188797
Substance Use and Sexual Risk Reduction Intervention for Homeless Youth
Brief AOD Use and Sexual Risk Reduction Group MI Intervention for Homeless
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study addresses an important gap in prevention services for homeless youth by conducting a pilot test of an innovative 4-session integrated substance use and sexual risk reduction program for this population that is feasible to deliver in settings where these youth seek services. The study has 2 specific aims:
Aim 1: Investigate whether homeless youth who participate in the program show reductions in substance use and intentions, behavior and consequences, as well as sexual activity intentions and risk behavior, over a 3-month period compared to a usual care control sample of youth who do not receive the program.
Aim 2: Gain a better understanding of intervention effects by exploring whether improvements in self-efficacy, readiness to change, outcome expectancies, and exposure to peer substance use and offers serve as explanatory mechanisms for reductions in substance use- and sexual activity- related intentions and risk behaviors among youth who participate in the program.
The program will be evaluated using a form of group-randomized design, although with crossover of conditions and groups to avoid the problems of power reduction associated with conventional group randomization. The unit of analysis will be the individual, but individuals will be assigned to groups based on the agency where they are seeking services. Youth at two drop-in centers serving homeless youth will either be in the intervention condition or a "usual care" control condition. The field period will be divided into four phases. The two agencies will alternate across phases in serving as the "intervention site" or "control site," with each agency having a total of two intervention phases and two control phases.
Intervention Condition: This condition involves a four-session voluntary intervention that is delivered within a drop-in center setting and is based on the investigator's previous intervention work with adolescents and young adults. Each session lasts approximately 1 hour. The intervention focuses on both sexual risk behavior and substance use. Although some sessions focus more heavily on sexual risk and others on substance use, each session includes content that emphasizes the interrelated nature of these two risk behaviors. In all sessions, participants will receive a personalized feedback sheet that specifically addresses a topic being discussed during that particular session. An motivational interviewing approach will be used to present material during the group sessions.
"Usual Care" Condition: The "usual care" condition reflects the resources typically available in settings that serve homeless youth: an HIV informational brochure that discusses the connection between substance use and HIV risk, and a Community Resource Guide that lists free or low-cost substance use and HIV-related services.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Hollywood, California, Estados Unidos
- My Friend's Place
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Venice Beach, California, Estados Unidos, 90291
- Safe Place for Youth
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- between 18-24 years, receiving services at one of the participating drop-in centers, planning to be in the study area for the next month
Exclusion Criteria:
- obvious cognitive impairment observed during screening process; non-English speaking
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Group MI risk reduction program
Participants receive four 1-hour group motivational interviewing sessions focused on reducing substance use and sexual risk behavior.
They also receive an HIV information brochure and Community Resource Guide.
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Sin intervención: Usual care control
Participant receive HIV information brochure and Community Resource Guide.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in substance use
Periodo de tiempo: baseline, 3 months
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past month quantity-frequency of alcohol and marijuana; past 3 months frequency of alcohol, binge drinking, marijuana, crack, cocaine, heroin, methamphetamine, ecstasy, hallucinogens, inhalants, prescription drug misuse
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baseline, 3 months
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Change in substance use intentions
Periodo de tiempo: baseline, 3 months
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Intentions to use the following in the next 3 months: alcohol; marijuana; other drugs
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baseline, 3 months
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Change in negative consequences from drinking
Periodo de tiempo: baseline, 3 months
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baseline, 3 months
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Change in use of drinking protective strategies
Periodo de tiempo: baseline, 3 months
|
baseline, 3 months
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Change in number of different sex partners
Periodo de tiempo: baseline, 3 months
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baseline, 3 months
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|
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Change in condom use
Periodo de tiempo: baseline, 3 months
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baseline, 3 months
|
|
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Change in substance use before or during sex
Periodo de tiempo: baseline, 3 months
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baseline, 3 months
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Change in HIV knowledge
Periodo de tiempo: baseline, 3 months
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baseline, 3 months
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Change in sex-related protective strategies
Periodo de tiempo: baseline, 3 months
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baseline, 3 months
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Change in sexual intentions
Periodo de tiempo: baseline, 3 months
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Separate items for intentions for buying/getting condoms, carrying condoms, talking to partner about condoms, using condoms, using condoms when drinking or using drugs, getting tested
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baseline, 3 months
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Change in HIV testing
Periodo de tiempo: baseline, 3 months
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Self-report of being tested in lifetime, past 3 months
|
baseline, 3 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R34DA034813 (Subvención/contrato del NIH de EE. UU.)
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