HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Effects of a Prenatally-Delivered Psychological Intervention for Parents and Their Babies With Single Ventricle Congenital Heart Disease

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).

• Single ventricle CHD diagnosis between 16 and 30 weeks gestation.

• Singleton pregnancy.

• Pregnant person is planning to continue with the pregnancy.

• Pregnant person is able to participate and complete study assessments in English.

Locations
United States
California
Children's Hospital Los Angeles
NOT_YET_RECRUITING
Los Angeles
Ohio
Children's Hospital Medical Center, Cincinnati
RECRUITING
Cincinnati
Other Locations
Australia
Sydney Children's Hospital
NOT_YET_RECRUITING
Randwick
The Children's Hospital at Westmead
NOT_YET_RECRUITING
Westmead
Contact Information
Primary
Nadine A. Kasparian, PhD
nadine.kasparian@cchmc.org
513-636-5575
Backup
James F. Cnota, MD
james.cnota@cchmc.org
513-636-3868
Time Frame
Start Date: 2025-07-14
Estimated Completion Date: 2027-12
Participants
Target number of participants: 50
Treatments
Experimental: HeartGPS (Treatment Arm)
Participants will receive usual fetal cardiac care plus the HeartGPS intervention. This is a novel psychological intervention leveraging virtual technology and user-centered design to reduce maternal psychological stress and anxiety after prenatal cardiac diagnosis and improve neurodevelopmental outcomes for infants with single ventricle CHD.~GPS stands for: Guiding through emotions, Providing information and support, and Strengthening connections.~The intervention includes sessions with a trained psychologist, coupled with tailored educational resources, and a personalized care plan to support longer-term parent, child, and family wellbeing.
No_intervention: Usual Fetal Cardiac Care (Control Arm)
In the usual care arm, participants will receive the information, support, and resources currently offered by their fetal heart care team. This can include support from their doctor or nurse, a social worker, psychologist, or support group, as well as information booklets, websites, and other resources to help parents learn more about their baby's heart condition.
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: Children's Hospital Los Angeles, Sydney Children's Hospitals Network

This content was sourced from clinicaltrials.gov