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Family Intervention Programs for Infant Development

N/A
Waitlist Available
Led By E M Cummings, Ph.D.
Research Sponsored by University of Notre Dame
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Both mothers and fathers agree to participate
Healthy infants with no known health problems
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study how different family-wide programs can promote healthy development in infants, mothers, fathers, and inter-parental relationships in cost-effective ways.

Who is the study for?
This trial is for cohabiting parents with healthy infants who have no known health problems. Both mothers and fathers must agree to participate. It's designed to help improve child and family health by enhancing early experiences and attachment.
What is being tested?
The study tests the effectiveness of family programs, including a Couples' Intervention, Sensitivity Intervention, both combined, or no intervention (Control). It aims to find cost-effective ways to support infant development and parent relationships.
What are the potential side effects?
Since this trial involves non-medical interventions focused on improving family dynamics and sensitivity towards the infant, there are not typical medical side effects; however, participants may experience emotional or psychological discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Both my partner and I agree to participate.
Select...
My infant is healthy with no known health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Brief Infant Toddler Emotional Assessment
Change in Child Care Activities Scale
Change in Conflict and Problem Solving Scale
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Sensitivity and Couples InterventionExperimental Treatment1 Intervention
Home visits combining sensitivity and couples' interventions; with COVID-19, we now conduct remote visits using Zoom
Group II: Sensitivity InterventionExperimental Treatment1 Intervention
Home visits to enhance mother-infant and father-infant parental sensitivity; with COVID-19, we now conduct remote visits using Zoom
Group III: Couples InterventionExperimental Treatment1 Intervention
Home visits to enhance constructive couples' communication; with COVID-19, we now conduct remote visits using Zoom
Group IV: ControlExperimental Treatment1 Intervention
Phone contacts with content not focusing on sensitivity or couples' relationships
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control
2011
Completed Phase 4
~15780

Find a Location

Who is running the clinical trial?

University of Notre DameLead Sponsor
33 Previous Clinical Trials
60,589 Total Patients Enrolled
1 Trials studying Infant Development
137 Patients Enrolled for Infant Development
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,054 Previous Clinical Trials
2,730,629 Total Patients Enrolled
9 Trials studying Infant Development
1,279 Patients Enrolled for Infant Development
E M Cummings, Ph.D.Principal InvestigatorUniversity of Notre Dame
~114 spots leftby Nov 2025
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