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

Part of paid clinical trials in Raleigh, North Carolina.

Sponsor
University of Washington
Study ID
NCT06740266
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Promoting First Relationships in Primary Care (PFR-PC) — BEHAVIORAL
    Promoting First Relationships® in Primary Care is based on attachment theory and is strengths-based. The intervention is delivered in 10 home visits, with 2 additional clinic visits. Each week has a theme for discussion, handouts, an activity, and time for "joining" - checking in with the parent, listening to their concerns, and establishing a positive, supportive relationship. The provider videotapes playtime between parent and child, and alternates weeks watching the video with the parent, reflecting about the needs of both parent and child (reflective observation). PFR consultation strategies include Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts. These core strategies enhance parents' sense of security and competency. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify their own feelings and needs around parenting.

Study Details

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).

Key Dates

Start date
Dec 13, 2024
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Promoting First Relationships in Primary Care (PFR-PC)
    PFR is a strengths-based, evidence-based home visiting approach to engage with families in ways that promote positive parenting change. PFR is a manualized training curriculum consisting of a 10-week (1 hour per visit) intervention. Each week has a theme for discussion and an activity. During five of the weekly sessions, the provider videotapes playtime between mother and child. On alternate weeks, the PFR provider and the mother watch the videotaped playtime and reflect about the needs of both the mother and the child. PFR-PC adds two additional visits at the medical home during routine well-child visits. PFR-PC is a manualized primary care delivery model with content that corresponds to developmentally appropriate content aligned with the well-child visits. Each family will receive two sessions at WakeMed during their well-child visits (approximately 20 minutes in length).
  • No Intervention: Usual care
    Usual care consists of routine pediatric medical well and sick care from WakeMed pediatrics, as well as already existing onsite integrated mental health and social work services.

Primary Outcome Measure

Telomere length change [ Time Frame: Baseline (Time 1), 12-months post-baseline (Time 3) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
WakeMed Health & HospitalsRaleighNorth Carolina27610
Carrie Dow-Smith, MD
[email protected]
LaMonica Daniel, ACRP-CP
[email protected]
1-919-350-7438
Carrie Dow-Smith, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Raleigh, NC

By research site
WakeMed Health & Hospitals· Raleigh, NC

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