Effectiveness of an Empirically Supported Family Intervention: Mental Health Outcomes, Mechanisms of Effect, and Organizational Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 3
- 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
- 是
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
研究组 & 干预措施
Parent-Child Intervention
This is a four-dose intervention that includes psychoeducational modules and communication coaching administered through community organizations over the course of four weeks. Both participating adults and the participating child receive materials to review each week, paired with weekly contact from a family coach.
干预措施: Parent-child intervention (Behavioral)
Self-study intervention
This is a four-dose intervention that include written self-study materials to review, paired with weekly contact with a family coach. Both participating adults receive self-study materials; the participating child does not receive separate materials.
干预措施: Self-study Intervention (Behavioral)
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