NCT06740266 The Impact of an Evidence-Based Parenting Service on Maternal Sensitivity and Infant Cellular Aging in a Population of Under-Resourced Families
| NCT ID | NCT06740266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Parent Child Relationship |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-12-13 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-12-13 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Monica Oxford, PhD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT06740266 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Parent Child Relationship. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06740266 currently recruiting?
Yes, NCT06740266 is actively recruiting participants. Contact the research team at mloxford@uw.edu for enrollment information.
Where is the NCT06740266 trial being conducted?
This trial is being conducted at Raleigh, United States.
Who is sponsoring the NCT06740266 clinical trial?
NCT06740266 is sponsored by University of Washington. The principal investigator is Monica Oxford, PhD at University of Washington. The trial plans to enroll 250 participants.