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Идёт набор NCT04980794

The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families

Без фазы С лечением Mental Health Conflict

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Parent-child intervention, Self-study Intervention.
Кому может быть актуально
Состояния в реестре: Mental Health, Conflict. Базовые параметры: от 4 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Effectiveness of an Empirically Supported Family Intervention: Mental Health Outcomes, Mechanisms of Effect, and Organizational Factors

Обзор

This study is designed to test the effectiveness of a psychoeducation-based program to address communication and conflict resolution in families, thereby supporting mental health in children and their caregivers.

Подробное описание

The goal of the study is to evaluate the effectiveness of a program to improve mental health in families by reducing stress and supporting effective communication and conflict resolution.

Families will be randomly assigned to one of two conditions: in the self-study condition, families will receive information to review on their own, paired with regular (weekly) contact from a family coach; in the second condition, families will receive information to review on their own, regular contact from a coach, and will participate in video sessions with a family coach who will provide feedback on their interactions and coaching on their use of a communication technique. Data collection, management and analysis will be conducted by researchers at the University of Notre Dame, but the intervention will occur through community organizations in three cities in Indiana, allowing for tests of the effectiveness of the program when it is implemented in community settings. Families will participate in a pre-test assessment, a four-week intervention, a post-test assessment, and a one-year follow up assessment. Also evaluated will be organizational factors and factors that impact ultimate implementation and scalability of the program in community settings.

Вмешательства

  • Поведенческое Parent-child intervention
    Families (two adult caregivers, child between 4 and 17) receive four interactive, asynchronous psychoeducation modules to review on their own paired with weekly contact with a communication coach and two live sessions with a communication coach to discuss psychoeducation, receive feedback on their interactions, and practice a communication technique.
  • Поведенческое Self-study Intervention
    Families (two adult caregivers) receive information in a newsletter format to review on their own, paired with weekly contact from a communication coach to answer questions and direct their attention toward specific topics in the newsletter.

Первичные конечные точки

  • Strengths and Difficulties Questionnaire (SDQ) [Срок оценки: 1 year]
  • Center for Epidemiological Studies Depression Scale (CESD) [Срок оценки: 1 year]
  • Revised Children's Manifest Anxiety Scale (RCMAS) [Срок оценки: 1 year]
  • Child Behavior Checklist (CBCL) [Срок оценки: 1 year]
  • O'Leary Porter Scale (OPS) [Срок оценки: 1 year]
  • Family Interactions Coding Scale [Срок оценки: 1 year]
  • Security in the Marital System Questionnaire (SIMS-PR) [Срок оценки: 1 year]
  • Security in the Subsystem (SIS) [Срок оценки: 1 year]
  • Security in the Family System (SIFS) [Срок оценки: 1 year]
  • Organizational Characteristics Measure (purpose created measure of organizational characteristics) [Срок оценки: 4 years]

Критерии участия

Критерии включения

  • Two parents or primary caregivers
  • Child between 4 and 17 years old
  • English literate
  • Able/willing to participate through the 12-month follow up assessment.

Критерии исключения

  • Families who cannot communicate in English
  • Single parent families

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • Fort Wayne Center for Children and Families — Fort Wayne
  • Indianapolis Virtual Site — Indianapolis
  • University of Notre Dame — Notre Dame

Идентификаторы

NCT: NCT04980794 · 20-0852

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗