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CenteringParenting Clinical Intervention on Kindergarten Readiness in Early Childhood

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Sep 2026 → Sep 2028
See other at-risk trials from Boston Medical Center

Record History

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  1. Notable Primary and study completion pushed from Sep 2026 to Sep 2028 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 600 participants (planned 1200)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Minor Re-verified, no change to tracked fieldsv13
  3. Notable Primary completion date: Jan 2025 to Sep 2026
    • Study completion date: Jan 2026 to Sep 2026
    v12
  4. Minor Re-verified, no change to tracked fieldsv11
  5. Notable Primary completion date: Mar 2023 to Jan 2025
    • Study completion date: Jun 2023 to Jan 2026
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv9
  2. Notable Primary completion date: Mar 2021 to Mar 2023
    • Study completion date: Jun 2021 to Jun 2023
    • Site contact updated
    v8
  3. Minor 2 versions Re-verified since Nov 10, 2019, no change to tracked fieldsv6-v7
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2019 to Feb 19, 2019
    • Site details revised
    v5
  5. Notable Start date: Nov 2018 to Mar 2019v4
  6. Minor Start date: Oct 2018 to Nov 2018v3
  7. Minor Start date: Sep 2018 to Oct 2018v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT03641092
Lead Sponsor Boston Medical Center
Collaborators: Centering Healthcare Institute, Overdeck Family foundation, Valhalla Foundation
Conditions
(from sponsor)
Parent-Child Relations, Parenting, Child Development, Child Behavior
Related terms Child Behavior
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov