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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how early life stress affects long-term health and whether a parenting program can reduce this stress for both mothers and their children. It compares a special 10-week parenting program, Promoting First Relationships® in Primary Care (PFR-PC), with regular care to determine if it can lower stress in mothers, improve parenting, and promote healthier children. Eligible participants are English- or Spanish-speaking mothers with a baby aged 3-12 months who receive care at WakeMed and are on Medicaid. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance parenting support and child health outcomes.

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 prior data suggests that the Promoting First Relationships in Primary Care program is safe for parent-child relationships?

Research has shown that the Promoting First Relationships® in Primary Care (PFR-PC) program is safe and well-received. Previous studies found that this parenting program strengthens the bond between parents and children without causing significant problems. PFR-PC is evidence-based, having been tested and reviewed by experts. These studies did not identify any major safety issues for parents or children involved.

Overall, the data supports PFR-PC as a safe and effective way to help families. Participants typically experience positive results, and the program is considered low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Promoting First Relationships in Primary Care (PFR-PC) because it offers a unique, hands-on approach to strengthening parent-child bonds, unlike typical pediatric care which focuses primarily on physical health and development. PFR-PC is distinctive because it incorporates videotaped playtime sessions and reflective discussions that help parents better understand and respond to their child's needs, fostering positive parenting changes. Additionally, it integrates seamlessly into routine well-child visits, making it a convenient option for families without needing separate appointments. This innovative approach aims to enhance mental and emotional development in children, potentially leading to stronger family relationships and healthier developmental outcomes.

What evidence suggests that the Promoting First Relationships in Primary Care program is effective for improving parent-child relationships?

Studies have shown that the Promoting First Relationships (PFR) program helps parents become more sensitive to their children's needs, enhancing their ability to understand and respond effectively. PFR has proven particularly beneficial for parents who experienced physical abuse as children. The program has also been linked to keeping families together, suggesting it strengthens family bonds. Research indicates that PFR positively impacts caregiver-child interactions, especially in diverse communities. These findings support the idea that PFR can reduce childhood stress and promote healthier parent-child relationships. In this trial, participants will receive either the Promoting First Relationships in Primary Care (PFR-PC) intervention or usual care, allowing for a comparison of outcomes between these approaches. ^{1 2 4 6 7}

Who Is on the Research Team?

Monica Oxford, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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 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]

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 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]

Citations

1. pfrprogram.org pfrprogram.org/wp-content/uploads/2025/04/Promoting-First-Relationships-Research-Summary-APR-2025.pdf

SUMMARY OF RESEARCH 19. PFR was more effective at improving sensitivity for birth parents who reported they were physically abused as children, and this effect moderated the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5357588/

Promoting First Relationships®: Randomized Trial of a 10 ... Overall, the results show support for the promise of PFR as an intervention for enhancing parent sensitivity and preventing child removals for families in the ...

3. pfrprogram.org pfrprogram.org/research/nih-funded-randomized-trials/

Randomized Controlled Trials Below is a list of Evidence-Based Clearinghouses that have rigorously evaluated the research outcomes associated with Promoting First Relationships (PFR).

4. pcrprograms.org pcrprograms.org/promoting-first-relationships-new-study-results/

Promoting First Relationships - New Study Results! In its first randomized clinical trial within an American Indian Community, Promoting First Relationships significantly improved observed parental ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35997845/

Promoting First Relationships® for Primary Caregivers and ... This study tested the effectiveness of Promoting First Relationships (PFR), a preventive intervention program aimed at fostering positive caregiver-child ...

6. pcrprograms.org pcrprograms.org/promoting-first-relationships/

Promoting First Relationships An evidence-based infant and early childhood mental health program for service providers, to help parents and other caregivers meet the social and emotional ...

7. pcrprograms.org pcrprograms.org/promoting-first-relationships-in-pediatric-primary-care/

Promoting First Relationships in Pediatrics An interactive program to learn how to nurture and support the parent-child relationship during everyday clinic interactions with families and children.