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

HeartGPS: A Longitudinal Randomized Controlled Trial Examining the Effects of a Prenatally-Delivered Psychological Intervention for Parents and Their Babies With Single Ventricle Congenital Heart Disease

This study tests whether an eight-session prenatal psychological program (HeartGPS) for parents of fetuses with single ventricle congenital heart disease can reduce parent distress and support fetal and infant brain and developmental outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Children's Hospital Medical Center, Cincinnati (Academic / other)
• Locations: 4 sites (Los Angeles, California and 3 other locations)
• Trial ID: NCT06175104 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Pregnant people aged 18 or older carrying a singleton fetus diagnosed with single ventricle congenital heart disease between 16 and 30 weeks gestation who plan to continue the pregnancy and can complete study activities in English are ideal candidates.

Not a fit: People whose fetus has a comorbid condition expected to markedly impair neurodevelopment (e.g., DiGeorge syndrome), those with untreated major psychiatric or substance use disorders, moderate-to-severe intellectual disability, surrogate pregnancies, or who cannot participate in English are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, HeartGPS could lower parental anxiety and depression around a prenatal single ventricle diagnosis and potentially improve fetal and infant brain development and early neurodevelopmental outcomes.

How similar studies have performed: Prenatal interventions specifically for parents of fetuses with single ventricle CHD are novel, though prior research links reduced maternal stress to better fetal brain outcomes in other contexts.

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.

Where this trial is running

Los Angeles, California and 3 other locations

• Children's Hospital Los Angeles — Los Angeles, California, United States (Not_yet_recruiting)
• Children's Hospital Medical Center, Cincinnati — Cincinnati, Ohio, United States (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

Conditions Heart Defects, Congenital; Anxiety in Pregnancy; Depression, Postpartum; Trauma, Psychological; Neurodevelopmental Disorders; Congenital Heart Disease; Prenatal; Mental Health