HeartGPS: Prenatal psychological support for parents and babies after a single ventricle heart diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-site randomized controlled trial enrolling 104 pregnant people carrying a fetus with single ventricle congenital heart disease to compare usual fetal cardiac care alone versus usual care plus the HeartGPS intervention. HeartGPS delivers eight prenatal psychology sessions, tailored educational resources, and a personalized care plan aimed at improving parental adjustment and parent–infant bonding. Outcomes measured across the perinatal period include parental anxiety, depression, and traumatic stress, as well as fetal and infant brain development, infant neurodevelopment, and parent–infant behavioral synchrony. The trial will also explore neurobiological, psychological, behavioral, and social factors that might explain any observed effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital Medical Center, Cincinnati
  Cincinnati, Ohio, United States Recruiting
• Children's Hospital Los Angeles
  Los Angeles, California, United States Not yet recruiting
• Sydney Children's Hospital
  Randwick, New South Wales, Australia Not yet recruiting
• The Children's Hospital at Westmead
  Westmead, New South Wales, Australia Not yet recruiting

Study contacts

• Principal investigator: Nadine A. Kasparian, PhD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Nadine A. Kasparian, PhD
• Email: nadine.kasparian@cchmc.org
• Phone: 513-636-5575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.