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Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Apr 2029 → Jul 2029
See other at-risk trials from Carelon Research

Record History

  1. Recruitment openedv2 Show 4 more changesShow less
    • Primary completion pushed from Apr 2029 to Jul 2029
    • Study completion pushed from Jun 2030 to Aug 2030
    • Start date changed from estimate of Apr 2026 to Jul 22, 2026
    • Site details revised at 17 of 17 sites
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a two-arm, prospective, longitudinal, randomized controlled trial (RCT) that will compare usual care to usual care plus a prenatally initiated, virtually administered psychological intervention, called HeartGPS.
Trial Details
NCT Number NCT07582861
Lead Sponsor Carelon Research
Conditions
(from sponsor)		 Congenital Heart Disease (CHD)
Related terms Heart Defects, Congenital
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov