Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT06740266

Conditions

Parent Child Relationship

Child Social-Emotional Development

Telomere Length

Epigenetic Aging

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Promoting First Relationships in Primary Care (PFR-PC)

Study Details

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).

Conditions

Parent Child Relationship

Child Social-Emotional Development

Telomere Length

Epigenetic Aging

Study ID

NCT06740266

Start date

Dec 13, 2024

Status verified date

Feb, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Promoting First Relationships in Primary Care (PFR-PC)

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.

Primary outcome measure

  • Telomere length change [ Time Frame: Baseline (Time 1), 12-months post-baseline (Time 3) ]
  • EpiAge clock change [ Time Frame: Baseline (Time 1), 12-months post-baseline (Time 3) ]
  • Maternal sensitive and responsive care change [ Time Frame: Baseline (Time 1), 6- months post baseline (Time 2), 12-months post-baseline (Time 3) ]
  • Maternal Knowledge of Social and Emotional Development change [ Time Frame: Baseline (Time 1), 6- months post baseline (Time 2), 12-months post-baseline (Time 3) ]

Central Contacts and Locations

Central contacts

Monica Oxford, PhD

206-685-6107mloxford@uw.edu

Mary Jane Lohr, MS

1-206-616-3373mjlohr@uw.edu

Locations

WakeMed Health & Hospitals

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Carrie Dow-Smith, MD

CDOW-SMITH@wakemed.org

LaMonica Daniel, ACRP-CP

1-919-350-7438LADANIEL@wakemed.org

Principal Investigator:

Carrie Dow-Smith, MD

More Information

Sponsor

University of Washington

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-02-06.