- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06803043
Un ensayo controlado aleatorio para evaluar un programa de intervención de violencia de socios informados por el trauma
The goal of this study is to conduct a randomized controlled trial (RCT) comparing outcomes between two programs to reduce intimate partner violence (IPV)- the Strength at Home (SAH) program and a standard, state-approved IPV intervention program, Treatment as Usual (TAU). Primary outcomes will include self- and partner-reported physical and psychological IPV. Secondary outcomes will include self-reported PTSD symptoms, alexithymia, alcohol use problems, and treatment satisfaction, assessed across five time points.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A mixed-methods approach will be used for this single site, parallel group RCT. All participants will be randomized at the individual level to Strength at Home (SAH) or Treatment as Usual (TAU), with a 1:1 allocation ratio. Assessments will occur pre-treatment and post-treatment with follow-up assessments scheduled every three months post-treatment through month 12. Assessments have been designed to examine reductions in IPV and other outcomes including posttraumatic stress disorder (PTSD) symptoms and alcohol use.
The primary hypotheses are that those receiving SAH will evidence greater reductions in physical and psychological IPV, symptoms of PTSD, alexithymia, and alcohol use problems, and higher treatment satisfaction relative to those receiving TAU across the time points.
The specific aims and sub aims are:
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Test the comparative effectiveness of SAH and TAU by conducting an RCT comparing 200 justice-involved men randomly assigned to each program.
- Compare the frequency of physical and psychological IPV, the primary outcomes of interest, across conditions as reported by the male participants and their intimate partners across Time 1 (baseline) and four 3-month follow ups (Times 2-5). Additionally, at Time 5, the study may make use of available arrest record data from the state of Rhode Island.
- Compare symptoms of PTSD, alexithymia, and alcohol use problems across conditions and assessment time points as reported by the male participants.
- Compare treatment satisfaction across conditions as reported by the male participants across the four 3-month follow ups (Times 2-5).
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Facilitate future use of SAH by working closely with the Stakeholder Advisory Board to identify potential barriers and facilitators to successful implementation in civilian community settings.
- Identify barriers and facilitators to implementation.
- Assess the acceptability of SAH among stakeholders in the community setting and areas in need of refinement.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- BU Chobanian & Avedisian School of Medicine, Psychiatry
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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:
- Men court-mandated to IPV intervention from the Rhode Island Department of Parole and Probation and their partners
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Strength at Home (SAH)
SAH isa trauma-informed 12-week intimate partner violence (IPV) intervention program. |
SAH is a group trauma informed intervention that uses motivational strategies and self-monitoring of one's thoughts and responses. It provides a unique fusion of interventions for trauma and IPV and consists of 12 two-hour weekly sessions. Throughout the program, group members complete in-session practice exercises and are provided "practice assignments" to consolidate and apply information learned in group. |
|
Comparador activo: Treatment as Usual (TAU)
TAU is a 20-week state-approved IPV intervention program. |
TAU is a court mandated 20 week, psychoeducational/directed program that emphasizes the sharing of power and control in relationships and personal accountability. Topics also focus on equality wheels, substance abuse impacts, culture and socialization impact on gender roles, defense mechanisms versus coping skills, triggers for stress and anger, and healthy versus unhealthy communication. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
IPV Assessment
Periodo de tiempo: Baseline, 3 months, 6 months, 9 months, 12 months
|
The Revised Conflict Tactics Scale (CTS2) is a 39-item measure of individual engagement in or experience of physical or psychological violence with an intimate partner. Each item is asked about both the respondent and the respondent's partner, for a total of 78 questions.The response options include 8 choices (Categories 1-7 and 0). An answer of Category 1 or 2 is coded as the corresponding number of times the specified incident occurred (once or twice in the past year). For Categories 3-5, the midpoint of the category is coded. For example: Category 3 (3-5 times) is coded as 4, Category 4 (6-10 times) is coded as 8, and Category 5 (11-20 times) is coded as 15. Category 6 (More than 20 times) should be coded as 25. Category 7 is given a score of 0 if scores for the previous year do not reflect abuse or conflict. Total scores can range from 0 to 975 and lower scores suggest less conflict. |
Baseline, 3 months, 6 months, 9 months, 12 months
|
|
Psychological IPV Assessment
Periodo de tiempo: Baseline, 3 months, 6 months, 9 months, 12 months
|
The 7-item Restrictive Engulfment subscale of the Multidimensional Measure of Emotional Abuse (MMEA) will be used as an additional measure of psychological IPV. Each item has 7 potential responses from 0=never to 6= more than 20 times. Scores can range from 0 to 42, with higher scores being associated with more psychological IPV. |
Baseline, 3 months, 6 months, 9 months, 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Post traumatic stress disorder (PTSD)
Periodo de tiempo: Baseline, 3 months, 6 months, 9 months, 12 months
|
The 20-item PTSD Checklist for DSM 5 (PCL-5) will be used to assess PTSD symptoms. It is a self-report measure. Items are rated on a 5-point Likert scale [0 to 4] and summed. Scores range from 0 to 80 with higher scores associated with more PTSD symptoms. A total score of 33 or higher may indicate severe PTSD. |
Baseline, 3 months, 6 months, 9 months, 12 months
|
|
Alexithymia
Periodo de tiempo: Baseline, 3 months, 6 months, 9 months, 12 months
|
The 20-itemToronto Alexithymia Scale (TAS-20) will be used to assess alexithymia. The TAS-20 uses cutoff scoring, with scores of 52-60 indicating possible alexithymia, and scores above 60 indicating alexithymia. |
Baseline, 3 months, 6 months, 9 months, 12 months
|
|
Alcohol Use
Periodo de tiempo: Baseline, 3 months, 6 months, 9 months, 12 months
|
Alcohol use will be assessed by the Alcohol Use Disorders Identification Test (AUDIT). AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. |
Baseline, 3 months, 6 months, 9 months, 12 months
|
|
Treatment satisfaction
Periodo de tiempo: 3 months, 6 months, 9 months, 12 months
|
Participants' satisfaction will be assessed with a 4-item measure used in a study conducted by the Treatment of Depression Collaborative Research Program. |
3 months, 6 months, 9 months, 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Casey T Taft, PhD, BU Chobanian & Avedisian School of Medicine, Psychiatry
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- H-45014
- BPS-2023C1-31039 (Otro número de subvención/financiamiento: PCORI)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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