RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-12-13
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06740266

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biological mother of infant aged 3-12 months English- or Spanish-speaking Receiving Medicaid Their infant is receiving pediatric care at WakeMed
  1. * 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

Contacts and Locations

Study Contact

Monica Oxford, PhD
CONTACT
206-685-6107
mloxford@uw.edu
Mary Jane Lohr, MS
CONTACT
1-206-616-3373
mjlohr@uw.edu

Principal Investigator

Monica Oxford, PhD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Monica Oxford, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-13
Study Completion Date2029-04

Study Record Updates

Study Start Date2024-12-13
Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

  • Epigenetic aging
  • Parenting intervention
  • Parent sensitivity
  • Pediatric setting

Additional Relevant MeSH Terms

  • Parent Child Relationship
  • Child Social-Emotional Development
  • Telomere Length
  • Epigenetic Aging