CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT03641092
Status
Recruiting
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Conditions

  • Child Behavior
  • Child Development
  • Parent-Child Relations
  • Parenting

Eligibility Criteria

Sex
ALL
Age
N/A - 3 Months
Healthy Volunteers
Accepted

Interventions

  • CenteringParenting Intervention — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Feb 19, 2019
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Early language assessment at 12 months [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Renee Boynton, MD, ScD
[email protected]
617-414-7477
Renee Boynton, MD, ScD (PRINCIPAL_INVESTIGATOR)

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By research site
Boston Medical Center· Boston, MA

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