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

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,005

Participants

Timeline

Start Date

January 11, 2017

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Behavior, Infant
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.

Trial Locations (2)

46535

William J. Shaw Center for Children and Families, South Bend

46814

Fort Wayne Center for Children and Families, Fort Wayne

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Notre Dame

OTHER

NCT03367845 - Efficacy of Family Programs for Improving Child and Family Health and Development | Biotech Hunter | Biotech Hunter