Actively Recruiting
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-07-20
50
Participants Needed
4
Research Sites
124 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
C
Children's Hospital Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease
- Diagnosis made between 16 and 30 weeks of pregnancy
- Singleton pregnancy
- Planning to continue with the pregnancy
- Able to participate and complete study assessments in English
You will not qualify if you...
- Fetus with a condition expected to negatively affect neurodevelopment (e.g., DiGeorge Syndrome)
- Any fetal or maternal medical condition that the doctor says makes study participation unsafe
- Parent has an untreated major psychiatric illness, substance use disorder, or other issues affecting safe study participation
- Parent has moderate to severe intellectual disability
- Parent is younger than 18 years old
- Pregnancy is being carried by a surrogate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Not Yet Recruiting
2
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, United States, 45229
Actively Recruiting
3
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Not Yet Recruiting
4
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
Research Team
N
Nadine A. Kasparian, PhD
CONTACT
J
James F. Cnota, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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