NCT04980794

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

4.8 years

First QC Date

July 13, 2021

Last Update Submit

November 13, 2024

Conditions

Outcome Measures

Primary Outcomes (12)

  • Strengths and Difficulties Questionnaire (SDQ)

    Youth Adjustment

    1 year

  • Center for Epidemiological Studies Depression Scale (CESD)

    Youth Adjustment

    1 year

  • Revised Children's Manifest Anxiety Scale (RCMAS)

    Youth Adjustment

    1 year

  • Child Behavior Checklist (CBCL)

    Youth Adjustment

    1 year

  • O'Leary Porter Scale (OPS)

    Interadult Conflict

    1 year

  • Family Interactions Coding Scale

    Observational measures of interadult and family conflict

    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

    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

    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

    1 year

  • Organizational Characteristics Measure (purpose created measure of organizational characteristics)

    Testing organizational factors associated with program effectiveness

    4 years

  • Leadership Perspective Measure (purpose created measure of organizational leaderships' perspective on program, implementation and sustainability)

    Testing organizational factors associated with program effectiveness

    4 years

  • Facilitator Perspective Measure (purpose created measure of community facilitators' perspective on program implementation and training)

    Testing organizational factors associated with program effectiveness

    4 years

Study Arms (2)

Parent-Child Intervention

EXPERIMENTAL

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

Self-study intervention

ACTIVE COMPARATOR

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

Interventions

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.

Parent-Child 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.

Self-study intervention

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Families who cannot communicate in English
  • Single parent families

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fort Wayne Center for Children and Families

Fort Wayne, Indiana, 46814, United States

RECRUITING

Indianapolis Virtual Site

Indianapolis, Indiana, 46260, United States

RECRUITING

University of Notre Dame

Notre Dame, Indiana, 46556, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Katie N Bergman, PhD

CONTACT

E. Mark Cummings, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are blind to condition assignments during their involvement in the program.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to one of two conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2021

First Posted

July 28, 2021

Study Start

March 1, 2021

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

November 15, 2024

Record last verified: 2024-11

Locations