Integrative Risk Reduction and Treatment for Teen Substance Use Problems and PTSD (RRFT)
2 de agosto de 2018 actualizado por: Medical University of South Carolina
Adolescents receiving RRFT and their caregivers will report significantly fewer substance use problems (quantity of use, frequency of use, and abuse symptoms) during treatment and follow-up than control adolescents who receive Treatment as Usual (TAU).
Adolescents receiving RRFT and their caregivers will report improvement in empirically-demonstrated risk and protective factors for substance use and abuse at the individual level (e.g., coping) and at each level of an adolescent's ecology (e.g., increased number of positive family activities, reduced family conflict, reduced number of peers who use drugs, improved school attendance, increased involvement in pro-social community activities) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will experience less PTSD symptoms (per youth and caregiver reports) during treatment and follow-up than control adolescents who receive TAU. Adolescents receiving RRFT will report engaging in fewer risky sexual behaviors (e.g., increased condom use, fewer partners) during treatment and follow-up than control adolescents who receive TAU. Changes during treatment in family relations (familial cohesiveness and conflict, satisfaction with caregiver-youth relationship) and parenting practices (monitoring) will mediate changes in substance use.
Changes during treatment in emotional reactivity will mediate changes in PTSD symptoms.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
See above.
Tipo de estudio
Intervencionista
Inscripción (Actual)
135
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
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina
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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
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 1) 13-18 years old;
- 2) Presenting to LCC/HH for evaluation or treatment;
- 3) Report having experienced IPV in their lifetime, including: CSA, defined as forced or unwanted: (a) vaginal or anal penetration by an object, finger, or penis; (b) oral sex; (c) touching of the respondent's breasts or genitalia; or (d) respondents' touching of another person's genitalia; CPA, defined as having been (a) attacked or threatened with a gun, knife, or some other weapon; (b) attacked by another person with perceived intent to kill or seriously injure; (c) beaten and injured (i.e., "hurt pretty badly") by another person; (d) spanked so forcefully that it resulted in sustained welts or bruises or required medical care; or (e) cut, burned, or tied up by a caregiver as a punitive consequence; Exposure to Domestic Violence; and being victim of or bearing witness to Community Violence.
- 4) Have a memory of the incident(s);
- 5) Five or more DSM-IV PTSD symptoms;
- 6) Substance use, defined as alcohol or illicit drug use in the past 90 days per self-report and/or urine drug screen or breathalyzer.
Exclusion Criteria:
- 1) Previously identified as having a Pervasive Developmental Disability or Moderate to Severe Mental Retardation;
- 2) Actively suicidal or homicidal;
- 3) Reports active psychotic disorder
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 paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Treatment as Usual (TAU)
Treatment as Usual (TAU) will be defined as it already exists within the community child advocacy centers.
This could include individual and/or group therapy using a variety of treatment models.
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Participants assigned to the TAU condition will receive the standard treatment that a CSA victim would typically receive at community advocacy centers.
In addition to treatment that is typically offered at the CACs, this will include a referral for substance abuse evaluation and may include referrals to other agencies in the community.
TAU has been utilized as a comparison condition for several behavioral treatment evaluations involving adolescent substance abuse.
Otros nombres:
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Experimental: RRFT
RRFT is an acronym for an experimental intervention named Risk Reduction through Family Therapy.
Please see intervention description for more detail about the model.
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RRFT is an integrative, ecologically-based approach to risk reduction and treatment.
A Stage 1a feasibility trial and a Stage 1b pilot randomized controlled trial (RCT) evaluating RRFT have been completed.
This Stage 1 work has resulted in a treatment manual, a clinician training protocol, and a quality assurance system.
Preliminary findings from these studies are promising, indicating that RRFT can be readily learned and implemented with fidelity, and that it can lead to improvements in drug use and drug use-related risk and protective factors, PTSD symptoms, and risky sexual behaviors.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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change in substance use problems (initiation/continuation, quantity, and abuse symptoms)
Periodo de tiempo: 18 months
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18 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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change in PTSD severity and symptoms
Periodo de tiempo: 18 months
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18 months
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change in risky sexual behaviors
Periodo de tiempo: 18 months
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18 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carla K Danielson, PhD, Medical University of South Carolina
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 (Actual)
1 de noviembre de 2012
Finalización primaria (Actual)
12 de julio de 2018
Finalización del estudio (Actual)
12 de julio de 2018
Fechas de registro del estudio
Enviado por primera vez
15 de noviembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
13 de diciembre de 2012
Publicado por primera vez (Estimar)
17 de diciembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
2 de agosto de 2018
Última verificación
1 de agosto de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Pro00009042
- R01DA031285-01 (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. .