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Efficacy of Family Programs for Improving Child and Family Health and Development

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: University of Notre Dame to Colorado State University
    • Primary completion date changed from estimate of Jun 30, 2026 to Jan 30, 2023
    • Study completion date: Jun 30, 2026 to Jun 30, 2028
    v9
  2. Primary and study completion dates: Mar 31, 2024 to Jun 30, 2026v8
  3. Primary and study completion dates: Mar 31, 2023 to Mar 31, 2024v7
  4. Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Enrollment target: estimated 1200 to confirmed 1005
    • Primary completion date: Dec 31, 2022 to Mar 31, 2023
    • Study completion date: Dec 31, 2023 to Mar 31, 2023
    • Site details revised at 2 of 2 sites
  5. Primary completion date: Dec 31, 2021 to Dec 31, 2022v5
  6. 3 versions Re-verified since Mar 12, 2019, no change to tracked fieldsv2-v4
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The proposed research is relevant to public health because of the critical importance of infant attachment and early experiences to the lifetime trajectory of mental health and socio-emotional functioning. This Randomized Clinical Trial addresses major gaps in available family-wide programs that can promote healthy development that best serve infants, mothers, fathers, and inter-parental relationships in cost-effective ways. This study also systematically tests for which families the interventions are most effective and rigorously tests the theoretical processes that link changes in mother-infant, father-infant, and mother-father interactions with infant and parent outcomes.
Trial Details
NCT Number NCT03367845
Lead Sponsor Colorado State University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Behavior, Infant
Related terms Infant Behavior
Enrollment 1,005 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov