Parenting Program for Parent-Child Relationships

Overseen By Mary Jane Lohr, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Acute crisis, Homelessness, No phone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 10 weeks

250 Participants Needed

Trial Summary

What is the purpose of 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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on parenting support rather than medication use.

What data supports the effectiveness of the treatment Promoting First Relationships in Primary Care (PFR-PC)?

The Promoting First Relationships® program has shown positive results in a Native community, improving attachment and social and emotional development in infants and toddlers. Additionally, similar parenting interventions in primary care settings have been effective in enhancing parenting practices and reducing child behavior problems. ^{1 2 3 4 5}

How is the Promoting First Relationships in Primary Care (PFR-PC) treatment different from other treatments for improving parent-child relationships?

Promoting First Relationships in Primary Care (PFR-PC) is unique because it focuses on enhancing the attachment and social-emotional development of infants and toddlers through a preventive approach, specifically tailored for primary care settings. It is evidence-based and has been adapted for diverse communities, making it distinct from other parenting programs that may not emphasize early attachment or be as culturally adaptable. ^{1 5 6 7 8}

Research Team

Monica Oxford, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for under-resourced families with young children. It's aimed at mothers who may be experiencing stress and are interested in a program that could help improve their parenting skills and potentially reduce stress-related aging in their infants.

Inclusion Criteria

Their infant is receiving pediatric care at WakeMed

I am the biological mother of a baby aged 3-12 months.

Receiving Medicaid

Exclusion Criteria

Homeless or without stable enough housing for home visits

Lacking access to a phone

Experiencing an acute crisis (e.g. hospitalization, incarceration)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Promoting First Relationships® in Primary Care (PFR in PC) program or Usual Care. PFR in PC is a 10-week home visiting service with 2 additional sessions at the WakeMed pediatric clinic.

10 weeks

10 home visits, 2 clinic visits

Follow-up

Participants are monitored for changes in telomere length, EpiAge clocks, maternal sensitivity, and child behavior problems.

12 months

3 visits (in-person) at baseline, 6 months, and 12 months

Treatment Details

Interventions

• Promoting First Relationships in Primary Care (PFR-PC)

Trial Overview The study compares the 'Promoting First Relationships in Primary Care' (PFR-PC) program, which includes home visits and clinic sessions, against the usual care provided at WakeMed pediatric clinic to see if PFR-PC can lower maternal stress, enhance sensitivity towards children, and slow down signs of early cellular aging.

Participant Groups

Group I: Promoting First Relationships in Primary Care (PFR-PC) Experimental Treatment 1 Intervention

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).

Group II: Usual care Active Control 1 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.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

WakeMed Health and Hospitals

Collaborator

Trials

8

Recruited

3,900+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

The Promoting First Relationships® (PFR) program was found to be effective in enhancing caregiver-child relationships and promoting personal growth among participants in a Native community, as evidenced by both quantitative and qualitative data from a randomized controlled trial.

Focus group discussions highlighted the importance of cultural relevance and provided valuable feedback on challenges faced by participants, suggesting that adaptations to the program could further improve its effectiveness in Native communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Native Participants in the Promoting First Relationships® Intervention: Focus Group Findings. O'Leary, R., Oxford, ML., Booth-LaForce, C., et al.[2023]

Developmental and behavioral services can be effectively integrated into primary care practices, leading to improved parental and provider satisfaction, as well as better parenting practices and health outcomes.

The 'planned care model' facilitated the implementation of these services, making it easier for healthcare providers to deliver care, which supports the case for broader adoption of such programs in child healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding developmental and behavioral services for newborns in primary care: implications of the findings. Thompson, RS., Lawrence, DM., Huebner, CE., et al.[2019]

The PriCARE intervention, which is designed to improve parenting skills and reduce child behavior problems, has shown effectiveness in three randomized controlled trials, making it a promising option for integration into pediatric primary care.

By implementing five synergistic strategies to enhance physician referrals, the referral rate for the PriCARE intervention significantly increased from 13% to 55%, demonstrating the potential for effective dissemination of parenting interventions in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and applying synergistic multilevel implementation strategies to promote reach of an evidence-based parenting intervention in primary care. Schilling, S., Bigal, L., Powell, BJ.[2023]

The Parent Connext program was successfully implemented in 11 pediatric practices, screening 13,346 visits, with 26% of families identified as having parenting and psychosocial concerns, demonstrating its feasibility in a primary care setting.

After the program, providers reported feeling more supported and confident in addressing family concerns, and 48% of referred families received individualized coaching, indicating the program's positive impact on both healthcare providers and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-located Parent Coaching Services Within Pediatric Primary Care: Feasibility and Acceptability. Eismann, EA., Folger, AT., Shapiro, RA., et al.[2021]

The PriCARE program, a 6-session group parent training, significantly reduced child behavior problems in preschool-aged children, with greater improvements in behavior scores compared to a control group.

Parents who participated in PriCARE also showed enhanced positive parenting attitudes, particularly in empathy towards children's needs and reduced reliance on corporal punishment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child-Adult Relationship Enhancement in Primary Care (PriCARE): A Randomized Trial of a Parent Training for Child Behavior Problems. Schilling, S., French, B., Berkowitz, SJ., et al.[2019]

The PriCARE program, which teaches positive parenting skills, effectively improved child behavior and parenting practices in preschool-aged children, as shown by significant reductions in behavior problem scores compared to a control group.

Incorporating a peer mentor into the PriCARE program reduced stigma among parents, although it did not significantly increase attendance at the sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child-Adult Relationship Enhancement in Primary Care: A Randomized Trial of a Skill-Based Parent Training with Parent Mentor Adaptation. Schilling, S., Ritter, V., Wood, JN., et al.[2021]

The PriCARE/CARIÑO intervention is a promising 6-session parenting program designed to improve parent-child relationships and reduce child maltreatment (CM) risk, specifically targeting low-income and minority families through primary care settings.

This multicenter randomized controlled trial will assess the effectiveness of PriCARE/CARIÑO by measuring the occurrence of CM investigations and various secondary outcomes over 48 months, making it the largest trial of its kind to explore mechanisms of change in CM prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child Adult Relationship Enhancement in Primary Care (PriCARE): study design/protocol for a randomized trial of a primary care-based group parenting intervention to prevent child maltreatment. Schilling, S., Powell, BJ., Stewart, PW., et al.[2023]

The Cariño program, a culturally adapted version of the PriCARE parenting program, was developed specifically for Spanish-speaking Hispanic parents, incorporating culturally relevant concepts to enhance its applicability and acceptance.

Pilot results showed that 62% of enrolled participants attended at least 4 out of 6 sessions, with high satisfaction ratings, indicating that the program is both feasible and well-received by the target audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Criando Niños Con Cariño : Primary Care-Based Group Parenting Program Adaptation and Pilot. Schilling, S., Romero-Cely, D., Mebane, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Experiences of Native Participants in the Promoting First Relationships® Intervention: Focus Group Findings. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Expanding developmental and behavioral services for newborns in primary care: implications of the findings. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Developing and applying synergistic multilevel implementation strategies to promote reach of an evidence-based parenting intervention in primary care. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Co-located Parent Coaching Services Within Pediatric Primary Care: Feasibility and Acceptability. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Child-Adult Relationship Enhancement in Primary Care (PriCARE): A Randomized Trial of a Parent Training for Child Behavior Problems. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Child-Adult Relationship Enhancement in Primary Care: A Randomized Trial of a Skill-Based Parent Training with Parent Mentor Adaptation. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Child Adult Relationship Enhancement in Primary Care (PriCARE): study design/protocol for a randomized trial of a primary care-based group parenting intervention to prevent child maltreatment. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Criando Niños Con Cariño : Primary Care-Based Group Parenting Program Adaptation and Pilot. [2023]