Recruiting

Observational Study

Sponsor:

Boston Medical Center

Code:

NCT03641092

Conditions

Parent-Child Relations

Parenting

Child Development

Child Behavior

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

CenteringParenting Intervention

Routine Well Child Care

Study Details

Brief summary:

Disparities in health begin in early childhood. Early life experiences influence brain development and have significant implications on future health and developmental outcomes. Low-income children are at greater risk of developmental delays in large part due to a lack of an enriched environment. Disparities in early childhood development increase risk for stunted academic achievement throughout the life course. Primary care is a universal exposure in early childhood and therefore is also a significant entry point for promoting optimal child development.

There is a need to provide effective, low-cost, and scalable interventions in primary care to support early childhood development.The CenteringParenting intervention is designed to reduce negative health and developmental outcomes within a model of group routine child health care. To date, there is no evidence of the benefits of the CenteringParenting intervention on school readiness, or improvements in parental behaviors that support optimal developmental milestones and achievement. The intent of this study is to determine the effectiveness of the CenteringParenting intervention on school readiness in early childhood, as measured by language development at 24 months, (in addition to health care utilization, child routine care maintenance, parenting stress, caregiver behaviors and attitudes).

Conditions

Parent-Child Relations

Parenting

Child Development

Child Behavior

Study ID

NCT03641092

Start date

Feb 19, 2019

Status verified date

Nov, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

For participating practice sites

  • Practice provides care to patients who are covered by public insurance and/or uninsured (no minimum threshold: all insurance types eligible)
  • Practices have at least 3,000 primary care visits per year

For parent-child dyad

  • Index child age must be 0-3 months
  • Parent must be female
  • Parent must be 18 years of age and older
  • Parent and child must attend one of the 10 study clinical sites
  • Parental consent
  • Parent must be fluent in English or Spanish

Exclusion Criteria:

For participating practice sites

  • Does not accept public insurance

For parent-child dyad

  • Child born prior to 34 weeks gestation
  • Child with chronic conditions known to affect neurodevelopment
  • Child with a positive screen on the Children with Special Healthcare Needs screener

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Experimental Clinical Site

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

active comparator: Comparison Clinical Site

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.

Interventions

CenteringParenting Intervention

The CenteringParenting(CP) intervention includes group well child care visits during the first 24 months of life. Participants receive a journal with child safety, health and development information. The groups are co-led by a practitioner and support staff member. This bundled intervention supports healthy parent-child interactions and early learning through education and experiential learning within the well-child visit.

Routine Well Child Care

The Comparison Clinical Sites will receive the Routine Well Child Care standard individual clinical care. This clinic will receive delayed training in the CenteringParenting(CP) intervention approximately 3 months after the completion of recruitment at their study site \[when recruited families will be ineligible for CenteringParenting groups that will start in control sites\]. They will receive anticipatory guidance and handouts that are standard for the clinic.

Primary outcome measure

  • Early language assessment at 12 months [ Time Frame: 12 months ]
  • Early language assessment at 24 months [ Time Frame: 24 months ]
  • Receptive vocabulary assessment at 3 months [ Time Frame: 3 months ]
  • Receptive vocabulary assessment at 12 months [ Time Frame: 12 months ]
  • Receptive vocabulary assessment at 24 months [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Renee Boynton, MD, ScD

617-414-7477renee.boyntonjarrett@bmc.org

Clare Viglione, MPH

617-352-5264Clare.Viglione@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Renee Boynton, MD, ScD

617-414-7477renee.boyntonjarrett@bmc.org

Principal Investigator:

Renee Boynton, MD, ScD

More Information

Sponsor

Boston Medical Center

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

Keywords

  • School readiness
  • Child development
  • Child behavior
  • Parenting behavior
  • CenteringParenting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2025-12-01.