CenteringParenting for Childhood Development

Overseen By Clare Viglione, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Preterm birth, Chronic conditions, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the CenteringParenting intervention can improve school readiness in young children, focusing on language development by age 2. The CenteringParenting approach involves group routine child health care to support early childhood development, particularly for low-income families. The study will compare this intervention to standard child healthcare practices (Routine Well Child Care). Families may qualify if they are enrolled in a practice that accepts public insurance and have a baby aged 0-3 months, with the parent being a fluent English or Spanish speaker. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance early childhood development strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the CenteringParenting intervention is safe for early childhood development?

Research shows that the CenteringParenting program aims to improve children's health and development through regular group-based healthcare. Studies have found that this method can lead to better health outcomes and is well-received by families in various communities. While specific safety data for the CenteringParenting model is unavailable, the emphasis on group care and parental involvement suggests it is likely well-tolerated. The lack of reported negative effects indicates it is generally safe for early childhood development. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CenteringParenting intervention because it offers a fresh approach to childhood development through group-based care. Unlike standard well-child visits, which usually involve one-on-one interactions with a healthcare provider, CenteringParenting creates a supportive community for parents and children by integrating social support and education into routine care. This method not only enhances developmental screening and health education but also fosters peer support among parents, which can lead to improved outcomes for both children and families. By focusing on group dynamics and shared learning, this intervention could reshape how pediatric care is delivered, making it more holistic and community-oriented.

What evidence suggests that the CenteringParenting intervention could be effective for early childhood development?

Research has shown that the CenteringParenting program, which participants in this trial may receive, is designed to improve health and development in young children. This program includes group-based child health care, which has proven effective for minority and low-income families. Although direct evidence of its effects on school readiness or parental behavior is not yet available, the program aims to enhance early childhood development. By creating enriched environments, CenteringParenting could improve language skills and other developmental milestones by 24 months of age. Overall, the program seeks to support better outcomes for children during their crucial early years. Participants in the comparison arm will receive Routine Well Child Care, serving as a control to evaluate the effectiveness of the CenteringParenting intervention. ^{1 3 5 6 7}

Who Is on the Research Team?

Renee Boynton, MD, ScD

Principal Investigator

Boston Medical Center

Are You a Good Fit for This Trial?

This trial is for parent-child pairs where the child is aged 0-3 months and the parent is at least 18 years old. The family must visit one of the study's ten clinical sites, be fluent in English or Spanish, and have public insurance or be uninsured. It excludes children with special healthcare needs, born before 34 weeks gestation, or with conditions affecting neurodevelopment.

Inclusion Criteria

For parent-child dyad: Parent and child must attend one of the 10 study clinical sites

I am a parent and I am 18 years old or older.

I am a mother participating with my child.

Exclusion Criteria

For parent-child dyad: Child born prior to 34 weeks gestation

My child has a chronic condition that affects their brain development.

For parent-child dyad: Child with a positive screen on the Children with Special Healthcare Needs screener

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the CenteringParenting intervention, including group well-child visits and educational materials

24 months

Annual clinical visits with group sessions

Follow-up

Participants are monitored for language development and parental behaviors at 12 and 24 months

24 months

Assessments at 12 and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• CenteringParenting Intervention
• Routine Well Child Care

Trial Overview The trial tests CenteringParenting Intervention against routine well child care to see if it improves kindergarten readiness by enhancing language development at age two. It also looks at health care use, maintenance of child routine care, parenting stress levels, and caregiver behaviors.

How Is the Trial Designed?

Group I: Experimental Clinical Site Experimental Treatment 1 Intervention

5 experimental clinical sites will receive the implementation of CenteringParenting assistance early. This arm will include the CenteringParenting intervention.

Group II: Comparison Clinical Site Active Control 1 Intervention

5 comparison clinical sites will receive Routine Well Child Care and CenteringParenting implementation assistance later and serve as control sites. This arm will include the Routine Well Child Care intervention.

CenteringParenting Intervention is already approved in United States for the following indications:

Approved in United States as CenteringParenting for:

• Early childhood development support
• Parental education and empowerment
• School readiness enhancement

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Overdeck Family foundation

Collaborator

Trials

1

Recruited

1,200+

Valhalla Foundation

Collaborator

Trials

2

Recruited

1,200+

Centering Healthcare Institute

Collaborator

Trials

1

Recruited

1,200+

Centering Healthcare Institute

Collaborator

Trials

1

Recruited

1,200+

Overdeck Family foundation

Collaborator

Trials

1

Recruited

1,200+

Valhalla Charitable Foundation

Collaborator

Trials

1

Recruited

1,200+

Published Research Related to This Trial

The study involved 100 families in France and found that those who received a safety kit along with counseling showed a significantly higher percentage of safety improvements in preventing child injuries compared to those who only received counseling.

Families with the safety kit demonstrated a 67.8% improvement in safety measures related to the devices provided, while those without the kit only showed a 38.1% improvement, highlighting the effectiveness of the kit in promoting safer home environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the effectiveness of an injury prevention kit delivery for toddlers in four French cities]. Sznajder, M., Janvrin, MP., Albonico, V., et al.[2019]

Primary care providers can significantly enhance child safety by offering anticipatory guidance on supervision during well-child visits, which can help prevent injuries and exposures before they occur.

Effective supervision should evolve with a child's development, focusing on direct supervision for younger children and gradually allowing more independence while ensuring a safe environment and healthy social interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adequate supervision for children and adolescents. Anderst, J., Moffatt, M.[2016]

The CenteringParenting model for well-child care was found to be highly acceptable and feasible among a diverse group of 40 parent-infant dyads at a federally qualified health center, with 97% to 100% of participants reporting satisfaction with their care.

Of the participants, 89% completed all scheduled visits from 2 weeks to 6 months, indicating strong engagement and positive experiences, which included increased confidence in parenting and social support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability in a Community-Partnered Implementation of CenteringParenting for Group Well-Child Care. Jones, KA., Do, S., Porras-Javier, L., et al.[2021]

A family-based reporting system for adverse events in pediatric inpatients did not significantly increase the reporting rates by healthcare providers, indicating a disconnect between family and staff perceptions of safety events.

Out of 321 events reported by families, 48% were legitimate safety concerns, highlighting that families can provide valuable insights into patient safety that are often overlooked by healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification by families of pediatric adverse events and near misses overlooked by health care providers. Daniels, JP., Hunc, K., Cochrane, DD., et al.[2022]

The CenteringParenting program significantly increased the number of well-child visits attended by infants in their first 15 months of life compared to traditional care, with an average of 9.19 visits versus 5.28 (p < 0.001).

Participants in the CenteringParenting program reported high satisfaction levels, highlighting the benefits of social interaction and support among mothers, which may enhance their overall experience and engagement in their children's health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of CenteringParenting: A Group Well-Child Care Model in an Urban Federally Qualified Community Health Center. Gullett, H., Salib, M., Rose, J., et al.[2019]

A qualitative study involving 26 mothers and 16 healthcare professionals found that most stakeholders view the Centering Parenting (CP) model as a desirable approach for delivering infant well-child care in Federally Qualified Health Centers (FQHCs).

Key facilitators for implementing CP include peer support, a focus on maternal wellness, and improved satisfaction among patients and clinicians, while barriers such as scheduling challenges and training requirements need to be addressed for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Implementing Group Well Baby/Well Woman Dyad Care at Federally Qualified Health Centers. Connor, KA., Duran, G., Faiz-Nassar, M., et al.[2022]

A scoping review of 388 studies from 1991 to 2012 revealed that children are particularly vulnerable to patient safety issues, with medication errors being the most common concern, identified in 48.7% of the studies.

The review highlighted the need for improved definitions and consistency in patient safety research to better compare and analyze results, emphasizing the importance of addressing both healthcare systems and caregiver perspectives in enhancing safety for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Care for Pediatric Patients: A Scoping Review Across Multiple Health Care Settings. Stang, A., Thomson, D., Hartling, L., et al.[2017]

The Supervising for Home Safety program effectively increased parents' awareness of their young children's injury risks and the importance of active supervision, with significant improvements noted immediately after the intervention and lasting for 12 months.

Parents who participated in the program reported higher self-efficacy in supervising their children, suggesting that the program could lead to better supervision practices and potentially reduce child injury risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating the impact of the Supervising for Home Safety program on parent appraisals of injury risk and need to actively supervise. Morrongiello, BA., Sandomierski, M., Zdzieborski, D., et al.[2018]

CenteringParenting is a group care model for mothers and infants that emphasizes continuity of care and addresses both maternal and infant health during the first year of life, promoting better health outcomes and satisfaction compared to traditional care.

The model fosters a supportive environment where mothers can discuss personal issues such as body image, breastfeeding, and mental health, recognizing the interconnectedness of maternal and infant health, and encouraging active participation in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CenteringParenting: an innovative dyad model for group mother-infant care. Bloomfield, J., Rising, SS.[2014]

Children participating in the CenteringParenting model were more likely to be up-to-date with their scheduled visits and vaccinations compared to those receiving traditional well-child care, indicating improved clinical outcomes.

Parents reported high satisfaction with the CenteringParenting model, appreciating the group setting for learning and support, which suggests that this approach may enhance parent engagement and overall care experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Centering Parenting Model With an Urban Pediatric Population to Measure and Improve Clinical Outcomes and Parent Satisfaction. Dimovitz, C., Butler, S., Wang, K., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03641092

CenteringParenting Clinical Intervention on Kindergarten ... The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. This ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10937253/

Feasibility and Acceptability in a Community-Partnered ... A community-academic partnership implemented CenteringParenting; the intervention was acceptable and feasible for a minority, low-income population.

3. withpower.com withpower.com/trial/phase-1-2019-1abe9

CenteringParenting for Childhood Development The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by ...

4. centeringhealthcare.org centeringhealthcare.org/uploads/files/CHI_CenteringParenting_2021.pdf

Improving the Earliest Years By delivering billable well-child visits in a group format over the first two years of life, CenteringParenting creates the space parents need.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8109838/

Parenting interventions to promote early child development ... We conducted a global systematic review and meta-analysis to evaluate the effectiveness of parenting interventions on ECD and parenting outcomes.

6. centeringhealthcare.org centeringhealthcare.org/what-we-do/centering-parenting

CenteringParenting CenteringParenting has lasting benefits for the baby, parents, and family · Better Health Outcomes. Data has shown that Centering families have better attendance ...

7. researchgate.net researchgate.net/publication/334526546_An_Evaluation_of_CenteringParenting_A_Group_Well-Child_Care_Model_in_an_Urban_Federally_Qualified_Community_Health_Center

A Group Well-Child Care Model in an Urban Federally ... Outcome measures: Quantitative outcome measures included the number of well-child visits attended, immunization and lead screening rates, as ...