An interventional study of Parent-child intervention and Self-study Intervention in Mental Health and Conflict, sponsored by University of Notre Dame. Recruiting at 3 sites in United States. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by University of Notre Dame · Not applicable, Interventional, and Treatment
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.
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.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's planned enrollment of 1,800 is above the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Notre Dame is the lead sponsor of 29 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Parent-child 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.
Behavioral: Self-study 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.
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.
Strengths and Difficulties Questionnaire (SDQ)
Youth Adjustment
Time frame: 1 year
Center for Epidemiological Studies Depression Scale (CESD)
Youth Adjustment
Time frame: 1 year
Revised Children's Manifest Anxiety Scale (RCMAS)
Youth Adjustment
Time frame: 1 year
Child Behavior Checklist (CBCL)
Youth Adjustment
Time frame: 1 year
O'Leary Porter Scale (OPS)
Interadult Conflict
Time frame: 1 year
Family Interactions Coding Scale
Observational measures of interadult and family conflict
Time frame: 1 year
Security in the Marital System Questionnaire (SIMS-PR)
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Time frame: 1 year
Security in the Subsystem (SIS)
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Time frame: 1 year
Security in the Family System (SIFS)
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
Time frame: 1 year
Organizational Characteristics Measure (purpose created measure of organizational characteristics)
Testing organizational factors associated with program effectiveness
Time frame: 4 years
Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)
Testing organizational factors associated with program effectiveness
Time frame: 4 years
Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)
Testing organizational factors associated with program effectiveness
Time frame: 4 years
Plan to share: Undecided
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