🔎 Trials Near Me

Home › NCT06740266

The Impact of an Evidence-Based Parenting Service on Maternal Sensitivity and Infant Cellular Aging in a Population of Under-Resourced Families

RecruitingHealthy volunteers welcome

The Impact of Stress and Caregiver Sensitivity on Infant Cellular Aging in a Population of Under-Resourced Families: A Randomized Controlled Trial

Who can join

Ages 18 and older · Women · Healthy volunteers welcome

Full eligibility 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

About the study

The goal of this clinical trial study is to learn how stress in childhood, or Early Life Adversity (ELA), gets "under the skin" and influences long-term health. The investigators will test if the support given to parents of young children reduces childhood stress. The investigators will also test if the effects of mother's stress and Early Life Adversity can be passed down to children. Can it impact the child's long-term health? Researchers will compare the Promoting First Relationships® in Primary Care (PFR in PC) parenting program with Usual Care to see if PFR reduces mothers' stress, improves mother's sensitivity, and reduces accelerated cellular aging.

Participants will:

* Be randomized to receive PFR in PC or Usual Care. PFR in PC is an evidence-based 10-week home visiting service, with 2 extra sessions at the WakeMed pediatric clinic. Usual Care is the health care and general services offered to families at the WakeMed pediatric clinic. * Have in-home research visits at the start of the study (Time 1, T1), about 6 months later (Time 2, T2), and 12 months later (Time 3, T3). Information collected at these visits includes:

* Answering questions about your background, past and current stress, physical and mental health, parenting behaviors, and child behavior problems (T1, T2, T3). * Being videotaped doing a short teaching activity. * Having a small amount of blood collected from the mother by finger prick (T1, T3). * Having a small amount of blood collected from the infant by heel stick (T1, T3).

What is being tested

Sponsor: University of Washington · Participants: 250 · Started: Dec 13, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06740266

Locations in the U.S.

North CarolinaWakeMed Health & Hospitals, Raleigh

From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.