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

Sponsor
University of Notre Dame (Other)
Overall Status
Recruiting
CT.gov ID
NCT04980794
Collaborator
(none)
1,800
3
2
58
600
10.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Parent-child intervention
  • Behavioral: Self-study Intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to one of two conditions.Participants are randomly assigned to one of two conditions.
Masking:
Single (Participant)
Masking Description:
Participants are blind to condition assignments during their involvement in the program.
Primary Purpose:
Treatment
Official Title:
Effectiveness of an Empirically Supported Family Intervention: Mental Health Outcomes, Mechanisms of Effect, and Organizational Factors
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2025
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

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.

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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Strengths and Difficulties Questionnaire (SDQ) [1 year]

    Youth Adjustment

  2. Center for Epidemiological Studies Depression Scale (CESD) [1 year]

    Youth Adjustment

  3. Revised Children's Manifest Anxiety Scale (RCMAS) [1 year]

    Youth Adjustment

  4. Child Behavior Checklist (CBCL) [1 year]

    Youth Adjustment

  5. O'Leary Porter Scale (OPS) [1 year]

    Interadult Conflict

  6. Family Interactions Coding Scale [1 year]

    Observational measures of interadult and family conflict

  7. Security in the Marital System Questionnaire (SIMS-PR) [1 year]

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

  8. Security in the Subsystem (SIS) [1 year]

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

  9. Security in the Family System (SIFS) [1 year]

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

  10. Organizational Characteristics Measure (purpose created measure of organizational characteristics) [4 years]

    Testing organizational factors associated with program effectiveness

  11. Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability) [4 years]

    Testing organizational factors associated with program effectiveness

  12. Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training) [4 years]

    Testing organizational factors associated with program effectiveness

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fort Wayne Center for Children and Families Fort Wayne Indiana United States 46814
2 Indianapolis Virtual Site Indianapolis Indiana United States 46260
3 University of Notre Dame Notre Dame Indiana United States 46556

Sponsors and Collaborators

  • University of Notre Dame

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Notre Dame
ClinicalTrials.gov Identifier:
NCT04980794
Other Study ID Numbers:
  • 20-0852
First Posted:
Jul 28, 2021
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 28, 2021