跳至主要内容
临床试验/NCT04980794
NCT04980794招募中不适用

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

University of Notre Dame6 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,800
试验地点
6
主要终点
Revised Children's Manifest Anxiety Scale (RCMAS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants are blind to condition assignments during their involvement in the program.

入排标准

年龄范围
4 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Families who cannot communicate in English
  • Single parent families

结局指标

主要结局

Revised Children's Manifest Anxiety Scale (RCMAS)

时间窗: 1 year

Youth Adjustment

Center for Epidemiological Studies Depression Scale (CESD)

时间窗: 1 year

Youth Adjustment

Strengths and Difficulties Questionnaire (SDQ)

时间窗: 1 year

Youth Adjustment

Security in the Marital System Questionnaire (SIMS-PR)

时间窗: 1 year

Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness

Child Behavior Checklist (CBCL)

时间窗: 1 year

Youth Adjustment

O'Leary Porter Scale (OPS)

时间窗: 1 year

Interadult Conflict

Family Interactions Coding Scale

时间窗: 1 year

Observational measures of interadult and family conflict

Security in the Subsystem (SIS)

时间窗: 1 year

Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness

Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)

时间窗: 4 years

Testing organizational factors associated with program effectiveness

Organizational Characteristics Measure (purpose created measure of organizational characteristics)

时间窗: 4 years

Testing organizational factors associated with program effectiveness

Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)

时间窗: 4 years

Testing organizational factors associated with program effectiveness

Security in the Family System (SIFS)

时间窗: 1 year

Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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