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Clinical trialNCT06175104RecruitingInterventional

HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis

SponsorChildren's Hospital Medical Center, CincinnatiEnrollment50Anxiety in PregnancyDepression, PostpartumHeart Defects, CongenitalNeurodevelopmental DisordersTrauma, Psychological
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Nadine A. Kasparian, PhD

    Children's Hospital Medical Center, Cincinnati

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Sydney Children'S Hospital

    Randwick, New South Wales, Australia

    Gary Sholler, MBBS
    Not, yet, recruiting
  • the Children'S Hospital at Westmead

    Westmead, New South Wales, Australia

    Gary Sholler, MBBS (Hons)Nadia Badawi, MBBS
    Not, yet, recruiting
United States
  • Children'S Hospital Los Angeles

    Los Angeles, California, United States

    Jay Pruetz, MDJodie Votava-Smith, MD
    Not, yet, recruiting
  • Children'S Hospital Medical Center, Cincinnati

    Cincinnati, Ohio, United States

    James F Cnota, MDNadine A Kasparian, PhD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
14 Jul 2025
Primary completion
31 Dec 2026
Completion
31 Dec 2027
Last update posted
20 Jul 2025
Registered enrollment
50
Registry id
NCT06175104

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.