- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Sharlene A Wolchik, PhD
- Электронная почта: wolchik@asu.edu
Учебное резервное копирование контактов
- Имя: Karey L O'Hara, PhD
- Номер телефона: 480-727-6136
- Электронная почта: klohara@asu.edu
Места учебы
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Arizona
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Tempe, Arizona, Соединенные Штаты, 85287
- Рекрутинг
- Arizona State University
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Контакт:
- Karey L O'Hara, PhD
- Номер телефона: 480-727-3623
- Электронная почта: klohara@asu.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age 18 years or older
- Fluent in English
- Court ordered to attend an intervention to reduce interparental conflict
Exclusion Criteria: None
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Child Anxiety Symptoms
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Emotion Regulation Difficulties
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- STUDY00015304
- R34MH126052 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .