Parenting Program for Parent-Child Relationships
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
No Placebo Group
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).
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.
23567What 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.
12468Will 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.
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.Exclusion Criteria
I have participated in the Promoting First Relationships program before.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Promoting First Relationships in Primary Care (PFR-PC)Experimental Treatment1 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 careActive Control1 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
WakeMed Health & HospitalsRaleigh, NC
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Who is running the clinical trial?
University of WashingtonLead Sponsor
WakeMed Health and HospitalsCollaborator
National Institute of Nursing Research (NINR)Collaborator
References
Expanding developmental and behavioral services for newborns in primary care: implications of the findings. [2019]In two other papers in this issue, the rationale, development, implementation, experimental design, approach to evaluation, and early results of a program to deliver developmental and behavioral services to all infants in primary care practice were described. Positive effects were seen for parental satisfaction, including decreased disenrollment, provider satisfaction, parenting practices, and health outcomes.
Child-Adult Relationship Enhancement in Primary Care (PriCARE): A Randomized Trial of a Parent Training for Child Behavior Problems. [2019]Child-Adult Relationship Enhancement in Primary Care (PriCARE) is a 6-session group parent training designed to teach positive parenting skills. Our objective was to measure PriCARE's impact on child behavior and parenting attitudes.
Child-Adult Relationship Enhancement in Primary Care: A Randomized Trial of a Skill-Based Parent Training with Parent Mentor Adaptation. [2021]Child-Adult Relationship Enhancement in Primary Care (PriCARE) is a 6-session group training designed to teach positive parenting skills. Parent engagement in such programs is a common implementation barrier. Our objectives were to (1) examine the impact of a peer mentor on attendance and stigma and (2) replicate a previous study by measuring PriCARE's impact on child behavior and parenting practices.
Co-located Parent Coaching Services Within Pediatric Primary Care: Feasibility and Acceptability. [2021]This project assessed the feasibility and acceptability of Parent Connext, a positive parenting program that integrates screening and co-located parent coaching within pediatric primary care.
Criando Niños Con Cariño : Primary Care-Based Group Parenting Program Adaptation and Pilot. [2023]This study culturally adapted and piloted a primary care-based group parenting program (Child-Adult Relationship Enhancement in Primary Care, PriCARE) for Spanish-speaking, Hispanic parents of 2- to 6-year-old children.
Experiences of Native Participants in the Promoting First Relationships® Intervention: Focus Group Findings. [2023]We tested Promoting First Relationships® (PFR), an evidence-based preventive intervention program for caregivers promoting attachment and social and emotional development of infants and toddlers, in a randomized controlled trial in a Native community. Quantitative results yielded evidence of efficacy; but in this report, our objective was to assess the participants' real-life experiences, challenges, and suggested enhancements to further adapt the program.
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]Child maltreatment (CM) is a pervasive public health problem and there is a critical need for brief, effective, scalable prevention programs. Problematic parent-child relationships lie at the heart of CM. Parents who maltreat their children are more likely to have punitive parenting styles characterized by high rates of negative interaction and ineffective discipline strategies with over-reliance on punishment. Thus, parenting interventions that strengthen parent-child relationships, teach positive discipline techniques, decrease harsh parenting, and decrease child behavioral problems hold promise as CM prevention strategies. Challenges in engaging parents, particularly low-income and minority parents, and a lack of knowledge regarding effective implementation strategies, however, have greatly limited the reach and impact of parenting interventions. Child Adult Relationship Enhancement in Primary Care (PriCARE)/Criando Niños con CARIÑO is a 6-session group parenting intervention that holds promise in addressing these challenges because PriCARE/CARIÑO was (1) developed and iteratively adapted with input from racially and ethnically diverse families, including low-income families and (2) designed specifically for implementation in primary care with inclusion of strategies to align with usual care workflow to increase uptake and retention.
Developing and applying synergistic multilevel implementation strategies to promote reach of an evidence-based parenting intervention in primary care. [2023]Background: This practical implementation report describes a primary care-based group parenting intervention-Child-Adult Relationship Enhancement in Primary Care (PriCARE)-and the approach taken to understand and strengthen the referral process for PriCARE within a pediatric primary care clinic through the deployment of synergistic implementation strategies to promote physician referrals. PriCARE has evidence of effectiveness for reducing child behavior problems, harsh and permissive parenting, and parent stress from three randomized controlled trials (RCTs). The integration of evidence-based parenting interventions into pediatric primary care is a promising means for widespread dissemination. Yet, even when integrated into this setting, the true reach will depend on parents knowing about and attending the intervention. A key factor in this process is the endorsement of and referral to the intervention by the child's pediatrician. Therefore, identifying strategies to improve physician referrals to parenting interventions embedded in primary care is worthy of investigation. Method: Through lessons learned from the RCTs and key informant interviews with stakeholders, we identified barriers and facilitators to physician referrals of eligible parent-child dyads to PriCARE. Based on this data, we selected and implemented five strategies to increase the PriCARE referral rate. We outline the selection process, the postulated synergistic interactions, and the results of these efforts. Conclusions: The following five discrete strategies were implemented: physician reminders, direct advertising to patients, incentives/public recognition, interpersonal patient narratives, and audit and feedback. These discrete strategies were synergistically combined to create a multifaceted approach to improve physician referrals. Following implementation, referrals increased from 13% to 55%. Continued development, application, and evaluation of implementation strategies to promote the uptake of evidence-based parenting interventions into general use in the primary care setting are discussed.