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

NCT06740266 | Recruiting

• 2 other identifiers: STUDY00019057R01NR021020
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

Epigenetic aging; Parenting intervention; Parent sensitivity; Pediatric setting

Outcome Measures

Primary Outcomes (4)

• Telomere length change

  DNA will be extracted from DBS samples using Qiagen's QIAamp DNA Mini Kit. Extracted DNA is quantified using a NanoDrop 2000 spectrophotometer (Thermo Fisher), checked for integrity using TapeStation bioanalyzer and Quant-iT Picogreen (Invitrogen) to specifically determine double-stranded DNA concentration.

  Baseline (Time 1), 12-months post-baseline (Time 3)

• EpiAge clock change

  DNAm will be determined using the Illumina Infinium Methylation EPIC v2.0 BeadChip Array (llumina Inc, CA) at Pennsylvania State University's genomics core lab. Arrays are processed using the Illumina iScan platform according to the manufacturer's protocol.

  Baseline (Time 1), 12-months post-baseline (Time 3)

• Maternal sensitive and responsive care change

  Parent sensitivity is measured by the Nursing Child Assessment Teaching Scale (NCATS; Barnard 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction. The range of this scale is zero to 73, higher scores indicate greater sensitivity

  Baseline (Time 1), 6- months post baseline (Time 2), 12-months post-baseline (Time 3)

• Maternal Knowledge of Social and Emotional Development change

  16-item Likert-scale questionnaire developed by the study, "Raising a Baby." The scale is summed, and scores could range from 16 to 64, with higher scores indicating greater parental knowledge.

  Baseline (Time 1), 6- months post baseline (Time 2), 12-months post-baseline (Time 3)

Secondary Outcomes (1)

• Child Behavior Problems change

  Baseline (Time 1), 6- months post baseline (Time 2), 12-months post-baseline (Time 3)

Study Arms (2)

Promoting First Relationships in Primary Care (PFR-PC)

EXPERIMENTAL

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).

Behavioral: Promoting First Relationships in Primary Care (PFR-PC)

Usual care

NO INTERVENTION

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) 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.

Promoting First Relationships in Primary Care (PFR-PC)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biological mother of infant aged 3-12 months English- or Spanish-speaking Receiving Medicaid Their infant is receiving pediatric care at WakeMed

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• WakeMed Health and Hospitals: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

RECRUITING

MeSH Terms

Interventions

Primary Health Care

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Monica Oxford, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Oxford, PhD

CONTACT

206-685-6107; mloxford@uw.edu

Mary Jane Lohr, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 18, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)