Actively Recruiting

Phase Not Applicable
Age: 0 - 3Months
All Genders
Healthy Volunteers
ID03641092

Evaluation of the Impact of the CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

Led by Boston Medical Center · Updated on 2025-12-01

1200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

B

Boston Medical Center

Lead Sponsor

C

Centering Healthcare Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Early childhood disparities in health and development can affect future academic success and overall well-being. Children from low-income families often face higher risks of developmental delays due to less stimulating environments, impacting language, social skills, and behavior critical for school readiness. This research evaluates the CenteringParenting intervention, a group-based routine child health care model, to see if it improves language development and parental behaviors that support early childhood development compared to standard care. The study compares two groups across multiple clinical sites: one receiving the CenteringParenting intervention involving group well-child visits led by practitioners and support staff with education and experiential learning, and another receiving routine individual well-child care with standard anticipatory guidance. The intervention includes providing parents with journals on child safety, health, and development, and aims to foster positive parent-child interactions and reduce social isolation. Control sites receive delayed training in CenteringParenting after recruitment ends. Participants include parent-child pairs where the child is under 3 months old at enrollment, and parents attend one of the study sites. Researchers will assess language development at 3, 12, and 24 months using standardized tools, and parental behaviors at 12 and 24 months. The study also evaluates the implementation fidelity and caregiver engagement with the intervention. The trial began in 2019 and is expected to continue through 2026.

CONDITIONS

Brief Title

CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

Who Can Participate

Age: 0 - 3Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Practice provides care to patients covered by public insurance and/or uninsured
  • Practices have at least 3,000 primary care visits per year
  • Child is aged 0 to 3 months at enrollment
  • Parent is female
  • Parent is 18 years of age or older
  • Parent and child attend one of the 10 study clinical sites
  • Parent provides consent
  • Parent is fluent in English or Spanish
Not Eligible

You will not qualify if you...

  • Practice does not accept public insurance
  • Child born before 34 weeks gestation
  • Child has chronic conditions known to affect neurodevelopment
  • Child screens positive on the Children with Special Healthcare Needs screener

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - Up to 3 months

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - Up to 24 months

Participants attend group well child care visits during the first 24 months of life. The intervention supports healthy parent-child interactions and early learning through education and experiential learning within the group well-child visit model.

Regular group well child visits during the first 24 months

Outpatient Treatment

Duration - Up to 24 months

Participants receiving routine well child care attend standard individual clinical care visits with anticipatory guidance and handouts as per clinic standards.

Standard individual well child visits during the first 24 months

Trial Site Locations

Total: 1 location

1

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

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Research Team

R

Renee Boynton, MD, ScD

C

Clare Viglione, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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