- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04980794
The Happy Families Project: Testing the Effectiveness of a Conflict Resolution Program for Families
Effectiveness of an Empirically Supported Family Intervention: Mental Health Outcomes, Mechanisms of Effect, and Organizational Factors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Katie N Bergman, PhD
- Phone Number: 574-631-0956
- Email: kbergman@nd.edu
Study Contact Backup
- Name: E. Mark Cummings, PhD
- Phone Number: 574-631-4947
- Email: ecumming@nd.edu
Study Locations
-
-
Indiana
-
Fort Wayne, Indiana, United States, 46814
- Recruiting
- Fort Wayne Center for Children and Families
-
Contact:
- Katie Bergman, PhD
- Phone Number: 574-631-0956
- Email: kbergman@nd.edu
-
Indianapolis, Indiana, United States, 46260
- Recruiting
- Indianapolis Virtual Site
-
Contact:
- Katie Bergman, PhD
- Phone Number: 574-631-0956
- Email: kbergman@nd.edu
-
Contact:
- John G Borkowski, PhD
- Email: jborkows@nd.edu
-
Notre Dame, Indiana, United States, 46556
- Recruiting
- University of Notre Dame
-
Contact:
- Katie Bergman, PhD
- Phone Number: 574-631-0956
- Email: kbergman@nd.edu
-
Contact:
- E. Mark Cummings, PhD
- Phone Number: 574-631-0956
- Email: ecumming@nd.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: 1 year
|
Youth Adjustment
|
1 year
|
|
Center for Epidemiological Studies Depression Scale (CESD)
Time Frame: 1 year
|
Youth Adjustment
|
1 year
|
|
Revised Children's Manifest Anxiety Scale (RCMAS)
Time Frame: 1 year
|
Youth Adjustment
|
1 year
|
|
Child Behavior Checklist (CBCL)
Time Frame: 1 year
|
Youth Adjustment
|
1 year
|
|
O'Leary Porter Scale (OPS)
Time Frame: 1 year
|
Interadult Conflict
|
1 year
|
|
Family Interactions Coding Scale
Time Frame: 1 year
|
Observational measures of interadult and family conflict
|
1 year
|
|
Security in the Marital System Questionnaire (SIMS-PR)
Time Frame: 1 year
|
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
|
1 year
|
|
Security in the Subsystem (SIS)
Time Frame: 1 year
|
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
|
1 year
|
|
Security in the Family System (SIFS)
Time Frame: 1 year
|
Youth Emotional Security: Testing process models associated with youth emotional security as the mechanism of effect for program effectiveness
|
1 year
|
|
Organizational Characteristics Measure (purpose created measure of organizational characteristics)
Time Frame: 4 years
|
Testing organizational factors associated with program effectiveness
|
4 years
|
|
Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)
Time Frame: 4 years
|
Testing organizational factors associated with program effectiveness
|
4 years
|
|
Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)
Time Frame: 4 years
|
Testing organizational factors associated with program effectiveness
|
4 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20-0852
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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