About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Biological mother of infant aged 3-12 months English- or Spanish-speaking Receiving Medicaid Their infant is receiving pediatric care at WakeMed
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Promoting First Relationships in Primary Care (PFR-PC)
BehavioralPromoting 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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
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.
Secondary outcomes
Child Behavior Problems change
The Infant-Toddler Social and Emotional Assessment (ITSEA) in English or Spanish is a standard child assessment tool assessing emotional and behavioral problems in young children. The ITSEA has been standardized and normed on a nationally representative sample that was stratified to match the 2002 U.S. Census. Mothers rated their infant on an extensive list of behaviors from 0 (not true/rarely) to 2 (very true/often). T scores are calculated. Higher T scores indicate more problem behaviour.
Sponsors and contacts
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University of Washington
Lead sponsor
WakeMed Health and Hospitals
Collaborator
National Institute of Nursing Research (NINR)
Collaborator