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Clinical Trials/NCT04980794
NCT04980794
Recruiting
N/A

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

University of Notre Dame3 sites in 1 country1,800 target enrollmentMarch 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health
Sponsor
University of Notre Dame
Enrollment
1800
Locations
3
Primary Endpoint
Revised Children's Manifest Anxiety Scale (RCMAS)
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
December 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Revised Children's Manifest Anxiety Scale (RCMAS)

Time Frame: 1 year

Youth Adjustment

Center for Epidemiological Studies Depression Scale (CESD)

Time Frame: 1 year

Youth Adjustment

Strengths and Difficulties Questionnaire (SDQ)

Time Frame: 1 year

Youth Adjustment

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

Child Behavior Checklist (CBCL)

Time Frame: 1 year

Youth Adjustment

O'Leary Porter Scale (OPS)

Time Frame: 1 year

Interadult Conflict

Family Interactions Coding Scale

Time Frame: 1 year

Observational measures of interadult and family conflict

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

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

Organizational Characteristics Measure (purpose created measure of organizational characteristics)

Time Frame: 4 years

Testing organizational factors associated with program effectiveness

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

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

Study Sites (3)

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