Condition: Heart Defects, Congenital · Anxiety in Pregnancy · Depression, Postpartum · Sponsor: Children's Hospital Medical Center, Cincinnati
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.
This description comes directly from the study's public registry record.
Nadine A. Kasparian, PhD · 513-636-5575 · nadine.kasparian@cchmc.org
James F. Cnota, MD · 513-636-3868 · james.cnota@cchmc.org
Always discuss trial participation with your own doctor first.
| Children's Hospital Los Angeles | Los Angeles, California, United States | Not Yet Recruiting |
| Children's Hospital Medical Center, Cincinnati | Cincinnati, Ohio, United States | Recruiting |
| Sydney Children's Hospital | Randwick, New South Wales, Australia | Not Yet Recruiting |
| The Children's Hospital at Westmead | Westmead, New South Wales, Australia | Not Yet Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06175104