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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04980794
• Other study ID #: 20-0852
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2023
• Source: University of Notre Dame
• Contact: Katie N Bergman, PhD
• Phone: 574-631-0956
• Email: kbergman[@]nd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Families who cannot communicate in English

• Single parent families

Related Conditions & MeSH terms

• Conflict
• Mental Health

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Fort Wayne Center for Children and Families	Fort Wayne	Indiana
United States	Indianapolis Virtual Site	Indianapolis	Indiana
United States	University of Notre Dame	Notre Dame	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Notre Dame

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strengths and Difficulties Questionnaire (SDQ)	Youth Adjustment	1 year
Primary	Center for Epidemiological Studies Depression Scale (CESD)	Youth Adjustment	1 year
Primary	Revised Children's Manifest Anxiety Scale (RCMAS)	Youth Adjustment	1 year
Primary	Child Behavior Checklist (CBCL)	Youth Adjustment	1 year
Primary	O'Leary Porter Scale (OPS)	Interadult Conflict	1 year
Primary	Family Interactions Coding Scale	Observational measures of interadult and family conflict	1 year
Primary	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	1 year
Primary	Security in the Subsystem (SIS)	Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness	1 year
Primary	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	1 year
Primary	Organizational Characteristics Measure (purpose created measure of organizational characteristics)	Testing organizational factors associated with program effectiveness	4 years
Primary	Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)	Testing organizational factors associated with program effectiveness	4 years
Primary	Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)	Testing organizational factors associated with program effectiveness	4 years