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

RecruitingNAAges 18 Years - anyAllChildren's Hospital Medical Center, Cincinnati
NCT06175104 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 interv

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD). 2. Single ventricle CHD diagnosis between 16 and 30 weeks gestation. 3. Singleton pregnancy. 4. Pregnant person is planning to continue with the pregnancy. 5. Pregnant person is able to participate and complete study assessments in English. Exclusion Criteria 1. Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome). 2. Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation. 3. 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. 4. Parent with a moderate to severe intellectual disability. 5. Parent age \<18 years. 6. Surrogate for pregnancy. Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
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What it tests

  • HeartGPS
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Where

4 sites
Children's Hospital Los Angeles
Los Angeles, United States
Children's Hospital Medical Center, Cincinnati
Cincinnati, United States
Sydney Children's Hospital
Randwick, Australia
The Children's Hospital at Westmead
Westmead, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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