- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00602732
Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse
Intervention for Low-income Pregnant Women With Partner Abuse
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Each year, approximately 324,000 pregnant women experience partner abuse (PA). With the emotional highs and lows that accompany new motherhood, pregnancy is often a challenging process for many women. Experiencing PA, while already going through a vulnerable time during pregnancy, may have harmful effects on the well-being of the woman and her infant. Women affected by PA are at an increased risk for certain physical and psychological problems, including depression and post-traumatic stress disorder (PTSD). Furthermore, the emotional distress from PA may impair a woman's ability to seek out the necessary support to ensure the safety of herself and her children. There have been few research efforts to develop an effective treatment to reduce the psychological impact of PA on pregnant women and even fewer efforts that target low-income women, who make up a large portion of affected women. The Reach Out for a Safe Environment (ROSE) program is an interpersonally oriented treatment developed to address factors that may contribute to postpartum mental health difficulties associated with PA. This study will evaluate the effectiveness of the ROSE program in preventing depression and PTSD in low-income pregnant women who have experienced recent PA.
Participation in this single-blind study will last approximately 29 weeks. All potential participants will answer an initial questionnaire concerning their history of physical, sexual, or emotional abuse in the past year. Selected participants will then undergo an interview about symptoms of depression, reactions to trauma, emotional difficulties, and alcohol and drug use. Participants invited to continue in the study will then be randomly assigned to the ROSE program or enhanced care as usual (ECU). Participants assigned to the ROSE program will attend four weekly 90-minute group sessions prior to delivery and one individual 50-minute booster session within 4 weeks of delivery. During these sessions, participants will learn ways to manage stress and negative feelings and how to access helpful resources. Participants will also complete two questionnaires about emotional difficulties per week for the duration of the program. Participants assigned to ECU will receive the usual medical care provided for pregnant women and will receive educational material on depression.
All participants will complete questionnaires and interviews about their emotional difficulties, relationships with others, and use of services for these difficulties prior to treatment assignment, 4 weeks after treatment assignment, 4 weeks after delivery, and 3 months after delivery. Participants in the ROSE program will additionally complete a questionnaire about their perceptions of the program after the fourth treatment session and after the booster session.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02905
- Memorial Hospital
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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:
- Able to speak and read English sufficiently to complete the study procedures
- Willing and able to receive public assistance
- Identified as having experienced physical assault based on responses to CTS2 within 1 year prior to study entry
- 35 weeks or less gestation
Exclusion Criteria:
- Meets current criteria for major depressive disorder or post-traumatic stress disorder
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 1
Participants assigned to the ROSE program
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Participants in the ROSE program will receive a course on managing stress and negative feelings and will learn how to access resources for help.
The ROSE program involves four 90-minute group sessions over a 4-week period prior to delivery.
Participants will also attend one 50-minute booster session within 4 weeks prior to delivery of their babies.
Otros nombres:
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Comparador activo: 2
Participants assigned to enhanced care as usual
|
Participants in ECU will receive the usual medical care provided for pregnant women at their prenatal clinic.
Participants will also receive educational material and a list of treatment resources for depression.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Longitudinal Interval Follow-up Examination (LIFE)
Periodo de tiempo: Measured at Year 1
|
Measured at Year 1
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Revised Conflict Tactic Scale (CTS2)
Periodo de tiempo: Measured at Year 1
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Measured at Year 1
|
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Edinburgh Postnatal Depression Scale
Periodo de tiempo: Measured at Year 1
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Measured at Year 1
|
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The Davidson Trauma Scale
Periodo de tiempo: Measured at Year 1
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Measured at Year 1
|
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The Arizona Social Support Interview Schedule
Periodo de tiempo: Measured at Year 1
|
Measured at Year 1
|
|
Parenting Stress Index
Periodo de tiempo: Measured at Year 1
|
Measured at Year 1
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Caron Zlotnick, PhD, Butler Hospital
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
- R34MH075013 (Subvención/contrato del NIH de EE. UU.)
- DSIR 83-ATP (NCT00719979)
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