NCT03641092 CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood
| NCT ID | NCT03641092 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Center |
| Condition | Parent-Child Relations |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2019-02-19 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,200 participants in total. It began in 2019-02-19 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Renee Boynton, MD, ScD
PRINCIPAL INVESTIGATOR
Boston Medical Center
Frequently Asked Questions
Who can join the NCT03641092 clinical trial?
This trial is open to participants of all sexes, up to 3 Months, studying Parent-Child Relations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03641092 currently recruiting?
Yes, NCT03641092 is actively recruiting participants. Contact the research team at renee.boyntonjarrett@bmc.org for enrollment information.
Where is the NCT03641092 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT03641092 clinical trial?
NCT03641092 is sponsored by Boston Medical Center. The principal investigator is Renee Boynton, MD, ScD at Boston Medical Center. The trial plans to enroll 1,200 participants.