The Unique and Combined Effects of Prenatal and Early Childhood Programming on Child Maltreatment: Examining Mechanisms of Change
Launched by UNIVERSITY OF NOTRE DAME · Dec 9, 2024
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The study will occur at two sites - the University of Notre Dame and the University of Memphis. A total of N=300 mother-child dyads will participate, with an equal number of dyads drawn from each site - Memphis, TN (n=115) and South Bend, IN (n=115). The sample will be composed of n=230 women and children drawn from an ongoing randomized clinical trial (RCT) of the PMEP (R01HD098092); during Year 1 of the current study, we will implement the PMEP RCT protocol with an additional n=70 women, for a total sample of N=300 families.
In order to be eligible for the PMEP trial arm, women must be: ...
Gender
ALL
Eligibility criteria
- • The sample will be composed of n=230 women and children drawn from an ongoing randomized clinical trial (RCT) of the PMEP (R01HD098092); during Year 1 of the current study, we will recruit an additional n=70 pregnant, IPV-exposed women and implement the PMEP RCT protocol with them, for a total sample of N=300 families.
- • In order to be eligible for the PMEP trial arm, women must be: 18 years or older, pregnant (between 10 and 30 weeks), English speaking, and exposed to IPV in the past year. To be eligible for re-enrollment in the RET trial arm, women must have previously participated in the PMEP trial arm. Women who have a significant mental health disorder or cognitive impairment that precludes their ability to understand or participate in the intervention will be excluded. Mothers who have experienced miscarriage, infant death, or who no longer have custody of the child with whom they were pregnant with when they participated in the PMEP trial arm will be excluded from the intervention given that the RET trial arm requires active participation from both parent and child; if, however, women have a child born after their participation in PMEP and who is in the study age range, they and their child may participate.
About University Of Notre Dame
The University of Notre Dame is a prestigious research institution dedicated to advancing knowledge and improving health outcomes through innovative clinical trials. Committed to excellence in research and education, the university leverages its interdisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies that address pressing medical challenges. With a focus on ethical practices and participant safety, the University of Notre Dame collaborates with healthcare professionals and community partners to translate scientific discoveries into effective therapies, ultimately enhancing patient care and contributing to the broader field of medical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madison, Wisconsin, United States
Notre Dame, Indiana, United States
Patients applied
Trial Officials
Laura E Miller-Graff, PhD
Principal Investigator
University of Notre Dame
Kathryn H Howell, PhD
Principal Investigator
University of Wisconsin, Madison
Kristin Valentino, PhD
Principal Investigator
University of Notre Dame
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported