NCT06175104 HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
| NCT ID | NCT06175104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Condition | Heart Defects, Congenital |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-07-14 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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.
Contact & Investigator
Nadine A. Kasparian, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Frequently Asked Questions
Who can join the NCT06175104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Defects, Congenital. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06175104 currently recruiting?
Yes, NCT06175104 is actively recruiting participants. Contact the research team at nadine.kasparian@cchmc.org for enrollment information.
Where is the NCT06175104 trial being conducted?
This trial is being conducted at Los Angeles, United States, Cincinnati, United States, Randwick, Australia, Westmead, Australia.
Who is sponsoring the NCT06175104 clinical trial?
NCT06175104 is sponsored by Children's Hospital Medical Center, Cincinnati. The principal investigator is Nadine A. Kasparian, PhD at Children's Hospital Medical Center, Cincinnati. The trial plans to enroll 50 participants.