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

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

• WakeMed Health and Hospitals

  collaborator OTHER

• National Institute of Nursing Research (NINR)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Monica Oxford, PhD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-13

Primary Completion

2028-05-31

Completion

2029-04-30

Countries

• United States

Study Locations