Status:
RECRUITING
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Children's Hospital Los Angeles
Sydney Children's Hospitals Network
Conditions:
Heart Defects, Congenital
Anxiety in Pregnancy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Maternal prenatal stress and anxiety can affect brain development in fetuses with and without congenital heart disease (CHD), influencing neurodevelopmental trajectories and establishing a neural basi...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
- Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
- Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
- Parent with a moderate to severe intellectual disability.
- Parent age \<18 years.
- Surrogate for pregnancy.
- Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
Exclusion
Key Trial Info
Start Date :
July 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06175104
Start Date
July 14 2025
End Date
December 1 2027
Last Update
July 20 2025
Active Locations (4)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, United States, 45229
3
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
4
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145