Impact of a parenting program on maternal sensitivity and infant health
The Impact of Stress and Caregiver Sensitivity on Infant Cellular Aging in a Population of Under-Resourced Families: A Randomized Controlled Trial
This study is testing if a parenting program can help mothers be more sensitive to their babies and improve their health, especially for families who might not have as many resources.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT06740266 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate how an evidence-based parenting program, Promoting First Relationships® in Primary Care (PFR in PC), affects maternal sensitivity and infant cellular aging in under-resourced families. Participants will be randomly assigned to receive either the PFR intervention or usual care at WakeMed pediatric clinic. The study will assess the impact of maternal stress and early life adversity on children's long-term health outcomes, particularly focusing on telomere length and epigenetic aging. The trial seeks to determine if improving caregiver sensitivity can mitigate the effects of stress on infants.
Who should consider this trial
Good fit: Ideal candidates include biological mothers of infants aged 3-12 months who are English- or Spanish-speaking and receiving Medicaid.
Not a fit: Patients experiencing acute crises, such as hospitalization or homelessness, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance maternal sensitivity and improve the long-term health of infants from under-resourced families.
How similar studies have performed: Other studies have shown promise in using parenting interventions to improve child health outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biological mother of infant aged 3-12 months English- or Spanish-speaking Receiving Medicaid Their infant is receiving pediatric care at WakeMed Exclusion Criteria: * Experiencing an acute crisis (e.g. hospitalization, incarceration) Homeless or without stable enough housing for home visits Lacking access to a phone Previously received the Promoting First Relationships intervention
Where this trial is running
Raleigh, North Carolina
- WakeMed Health & Hospitals — Raleigh, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Monica Oxford, PhD — University of Washington
- Study coordinator: Monica Oxford, PhD
- Email: mloxford@uw.edu
- Phone: 206-685-6107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.