- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07816445
Pilot Study of an Interparental Conflict Intervention for Separating or Divorcing Parents
Pilot Study to Test Effects of a New Interparental Conflict Intervention for Separating or Divorcing Parents
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a randomized pilot trial of a new, scalable intervention for separating or divorcing parents experiencing interparental conflict. The intervention was developed by adapting components of existing evidence-based interventions using human-centered design methods. The intervention is designed to teach parents skills for reducing children's exposure to interparental conflict and protecting children's mental health and well-being.
Approximately 94 parents who are court ordered to participate in an intervention addressing interparental conflict will be randomly assigned to either the new intervention or an existing court-based program. The new intervention is expected to include an orientation session followed by three or four digital sessions. The pilot study will evaluate implementation outcomes, including feasibility, acceptability, appropriateness, and usability, as well as preliminary effects on interparental conflict and children's internalizing and externalizing problems. The study will also examine parents' use of skills intended to protect children from interparental conflict and interpersonal violence and parents' emotion-regulation skills.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sharlene A Wolchik, PhD
- Correo electrónico: wolchik@asu.edu
Copia de seguridad de contactos de estudio
- Nombre: Karey L O'Hara, PhD
- Número de teléfono: 480-727-6136
- Correo electrónico: klohara@asu.edu
Ubicaciones de estudio
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Arizona
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Tempe, Arizona, Estados Unidos, 85287
- Reclutamiento
- Arizona State University
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Contacto:
- Karey L O'Hara, PhD
- Número de teléfono: 480-727-3623
- Correo electrónico: klohara@asu.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- Fluent in English
- Court ordered to attend an intervention to reduce interparental conflict
Exclusion Criteria: None
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: Family COMPASS
Participants receive Family COMPASS, a four-session parenting intervention for parents experiencing high levels of interparental conflict following separation or divorce.
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Family COMPASS (Conflict Management through Purposeful Awareness, Strategies, and Support) is a manualized, trauma-informed parenting intervention designed to reduce children's exposure to interparental conflict following parental separation or divorce.
The intervention consists of four highly structured, approximately 30-minute sessions delivered virtually or in person by trained personnel.
It focuses on strengthening parents' emotion regulation, communication, co-parenting, conflict management, and safety planning skills.
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Comparador activo: Families in Transition (FIT)
Participants receive FIT, an existing 90-minute online parent education program designed to help separating or divorcing parents reduce interparental conflict and children's exposure to conflict.
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FIT is a 90-minute online parent education program developed by the Superior Court of Maricopa County in collaboration with the National Center for State Courts.
The program includes four modules, a film, and interactive activities.
It validates parents' difficult feelings toward their co-parent while emphasizing behavior change to protect children from interparental conflict.
Content addresses the effects of interparental conflict on children, prioritizing children's needs, developing a child-focused vision for the future, and using practical strategies to reduce conflict behaviors.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Child Anxiety Symptoms
Periodo de tiempo: Baseline and 30 days after program completion
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Parent-reported child anxiety symptoms assessed using the Anxiety subscale of the Revised Child Anxiety and Depression Scale-25 Parent Version (RCADS-25-P).
The Anxiety subscale contains 15 items rated from 0 (Never) to 3 (Always).
Raw scores range from 0 to 45, with higher scores indicating greater anxiety symptoms.
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Baseline and 30 days after program completion
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Child Depressive Symptoms
Periodo de tiempo: Baseline and 30 days after program completion
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Parent-reported child depressive symptoms assessed using the Depression subscale of the Revised Child Anxiety and Depression Scale-25 Parent Version (RCADS-25-P).
The Depression subscale contains 10 items rated from 0 (Never) to 3 (Always).
Raw scores range from 0 to 30, with higher scores indicating greater depressive symptoms.
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Baseline and 30 days after program completion
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Child Irritability/Anger
Periodo de tiempo: Baseline and 30 days after program completion
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Parent-reported child irritability and anger assessed using the irritability/anger item of the DSM-5 Level 1 Cross-Cutting Symptom Measure-Parent/Guardian-Rated Measure for Children Ages 6-17.
The item is rated from 0 (Not at all) to 4 (Nearly every day).
Scores range from 0 to 4, with higher scores indicating greater irritability/anger.
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Baseline and 30 days after program completion
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Child Attention Problems
Periodo de tiempo: Baseline and 30 days after program completion
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Parent-reported child attention problems assessed using the attention item of the DSM-5 Level 1 Cross-Cutting Symptom Measure-Parent/Guardian-Rated Measure for Children Ages 6-17.
The item is rated from 0 (Not at all) to 4 (Nearly every day).
Scores range from 0 to 4, with higher scores indicating greater attention problems.
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Baseline and 30 days after program completion
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Interparental Conflict
Periodo de tiempo: Baseline and 30 days after program completion
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Parent-reported interparental conflict assessed using the 13-item intensity and frequency subscales of the Children's Perception of Interparental Conflict Scale, adapted for parent report.
Items are rated on a 3-point scale and appropriately reverse-scored.
Using summed item scores coded from 0 to 2, total scores range from 0 to 26, with higher scores indicating greater interparental conflict.
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Baseline and 30 days after program completion
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Intervention Feasibility
Periodo de tiempo: Approximately 30 days after program completion
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Parent-reported feasibility assessed using the 4-item Feasibility of Intervention Measure (FIM).
Items are rated from 1 (Completely disagree) to 5 (Completely agree), with scores ranging from 4 to 20.
Higher scores indicate greater perceived feasibility.
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Approximately 30 days after program completion
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Intervention Acceptability
Periodo de tiempo: Approximately 30 days after program completion
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Parent-reported acceptability assessed using the 4-item Acceptability of Intervention Measure (AIM).
Items are rated from 1 (Completely disagree) to 5 (Completely agree), with scores ranging from 4 to 20.
Higher scores indicate greater acceptability.
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Approximately 30 days after program completion
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Intervention Appropriateness
Periodo de tiempo: Approximately 30 days after program completion
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Parent-reported appropriateness assessed using the 4-item Intervention Appropriateness Measure (IAM).
Items are rated from 1 (Completely disagree) to 5 (Completely agree), with scores ranging from 4 to 20.
Higher scores indicate greater perceived appropriateness.
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Approximately 30 days after program completion
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Intervention Usability
Periodo de tiempo: Approximately 30 days after program completion
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Parent-reported intervention usability assessed using the 10-item Intervention Usability Scale (IUS).
Items are rated on a 5-point agreement scale.
Positively and negatively worded items are scored according to standard IUS scoring procedures, and the summed score is multiplied by 2.5.
Total scores range from 0 to 100, with higher scores indicating greater perceived intervention usability.
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Approximately 30 days after program completion
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Emotion Regulation Difficulties
Periodo de tiempo: Baseline and 30 days after program completion
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Parent-reported difficulties in emotion regulation assessed using the 16-item Difficulties in Emotion Regulation Scale-Short Form (DERS-SF).
Items are rated from 1 (Almost Never) to 5 (Almost Always), with total scores ranging from 16 to 80. Higher scores indicate greater difficulties with emotion regulation.
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Baseline and 30 days after program completion
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Confidence in Making a Safety Plan for Self
Periodo de tiempo: Baseline and 30 days after program completion
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Parent-reported confidence in the ability to make a safety plan for oneself, assessed using a single-item rating scale ranging from 0 (Not at all confident) to 100 (Completely confident).
Higher scores indicate greater confidence in safety planning.
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Baseline and 30 days after program completion
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Confidence in Making a Safety Plan for Children
Periodo de tiempo: Baseline and 30 days after program completion
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Parent-reported confidence in the ability to make a safety plan for one's child or children, assessed using a single-item rating scale ranging from 0 (Not at all confident) to 100 (Completely confident).
Higher scores indicate greater confidence in safety planning.
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Baseline and 30 days after program completion
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
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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
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Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00015304
- R34MH126052 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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