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ACTIVE NOT RECRUITING
NCT03367845
NA

Efficacy of Family Programs for Improving Child and Family Health and Development

Sponsor: University of Notre Dame

View on ClinicalTrials.gov

Summary

The proposed research is relevant to public health because of the critical importance of infant attachment and early experiences to the lifetime trajectory of mental health and socio-emotional functioning. This Randomized Clinical Trial addresses major gaps in available family-wide programs that can promote healthy development that best serve infants, mothers, fathers, and inter-parental relationships in cost-effective ways. This study also systematically tests for which families the interventions are most effective and rigorously tests the theoretical processes that link changes in mother-infant, father-infant, and mother-father interactions with infant and parent outcomes.

Key Details

Gender

All

Age Range

6 Months - Any

Study Type

INTERVENTIONAL

Enrollment

1005

Start Date

2017-01-11

Completion Date

2026-06-30

Last Updated

2025-06-22

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Control

Parents receive 8 phone contacts (1 per week) that do not focus on material in the sensitivity and couples communication intervention.

BEHAVIORAL

Sensitivity Intervention

4 home visits take place. Mothers and fathers are video recorded with their infant (separately) for approximate 10-15 minutes at the beginning of each visit. The recorded situations are natural (e.g., playing together, bathing the baby, mealtime, etc.) and the family coach (interventionist) is not actively involved in the parent-child interaction. A different theme is covered across the four intervention sessions. For each parent-infant interaction recording, the family coach reviews the recordings between visits and provides feedback to parents in the following intervention session. The exception to this is that video of parent-child interactions during the lab pre-test is used for material at the first home visit. Each session takes approximately 90 minutes. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom.

BEHAVIORAL

Couples' Intervention

The psycho-educational inter-parental conflict prevention curriculum is a 4-session program that takes place in the families' homes. Each session lasts approximately 90 minutes and involves discussion and practice of four themes pertinent to improving conflict process, communication, and emotional security in the family: Conflict Overview, Interparental Conflict and Children, Stresses of Parenting, and Emotional Security. The family coach scaffolds and supports the couples' development of constructive conflict behaviors. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom.

BEHAVIORAL

Sensitivity and Couples' Intervention

This group receives both the Sensitivity and Couples' Intervention in their home. There are 8 home visits (4 for Sensitivity and 4 for Couples Intervention). Because of COVID-19, we now conduct remote visits using Zoom.

Locations (2)

Fort Wayne Center for Children and Families

Fort Wayne, Indiana, United States

William J. Shaw Center for Children and Families

South Bend, Indiana, United States