Actively Recruiting
The Impact of Stress and Caregiver Sensitivity on Infant Cellular Aging in a Population of Under-Resourced Families: A Randomized Controlled Trial
Led by University of Washington · Updated on 2026-02-06
250
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
W
WakeMed Health and Hospitals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how childhood stress, known as Early Life Adversity (ELA), affects long-term health by studying its impact on cellular aging in infants from under-resourced families. This study aims to see if supporting parents through the Promoting First Relationships® in Primary Care (PFR in PC) program can reduce maternal stress, improve maternal sensitivity, and slow down accelerated cellular aging in children. It also explores whether a mother's stress and ELA affect her child's cellular aging and long-term health. Participants will be randomly assigned to either the PFR in PC group or to receive usual care. PFR in PC is a structured 10-week home visiting program, with weekly visits featuring discussions, activities, and videotaped play sessions that help parents better understand and respond to their child's needs. Additionally, there are two brief clinic visits during well-child appointments. The usual care group receives standard pediatric medical services and existing mental health and social support at the clinic. During the study, families will have home visits at the start, about six months later, and again at 12 months. At these visits, researchers will collect information on parental stress, health, parenting behaviors, and child behavior through questionnaires and videotaped activities. Blood samples from mothers and infants will be collected to measure telomere length and epigenetic age, markers of cellular aging. The study also monitors changes in maternal sensitivity, knowledge about child development, and child behavior over time, aiming to understand how the intervention influences these factors and infant cellular aging.
CONDITIONS
Brief Title
The Impact of an Evidence-Based Parenting Service on Maternal Sensitivity and Infant Cellular Aging in a Population of Under-Resourced Families
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biological mother of an infant aged 3 to 12 months
- English- or Spanish-speaking
- Receiving Medicaid
- Infant is receiving pediatric care at WakeMed
You will not qualify if you...
- Experiencing an acute crisis such as hospitalization or incarceration
- Homeless or without stable enough housing for home visits
- Lacking access to a phone
- Previously received the Promoting First Relationships intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants in the treatment group receive 10 weekly home visits focusing on promoting positive parenting through the Promoting First Relationships® model, plus 2 additional clinic visits during routine well-child visits. Each session includes discussion, activities, and videotaped playtime to enhance caregiver sensitivity and responsive care.
10 weekly home visits and 2 clinic visits during well-child appointments
Duration - Up to 12 months post-baseline
Participants attend follow-up visits to assess the impact of the intervention on child cellular aging and maternal sensitivity, with assessments at 6 months and 12 months post-baseline.
2 follow-up visits at 6 and 12 months post-baseline (in-person)
Trial Site Locations
Total: 1 location
1
WakeMed Health & Hospitals
Raleigh, North Carolina, United States, 27610
Actively Recruiting
Research Team
M
Monica Oxford, PhD
M
Mary Jane Lohr, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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