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

Key facts

Who runs it
Children's Hospital Medical Center, Cincinnati
Where
Cincinnati and Los Angeles, United StatesSee the 2 sitesAlso in 1 other country, 2 sites
Trial code
Status
Recruiting
People taking part
50 people, planned
Started
14 Jul 2025
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • HeartGPS
Record updated
20 July 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Surrogate for pregnancy; Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion
  • 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 age <18 years
  • Parent with a moderate to severe intellectual disability

Where in United States

Also in 1 other country, 2 sites

  • Children's Hospital Medical Center, CincinnatiCincinnati, United StatesContact: Nadine A Kasparian, PhDTaking people
  • Children's Hospital Los AngelesLos Angeles, United StatesContact: Jodie Votava-Smith, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • HeartGPS (Treatment Arm)Treatment being tested

    Participants will receive usual fetal cardiac care plus the HeartGPS intervention. This is a novel psychological intervention leveraging virtual technology and user-centered design to reduce maternal psychological stress and anxiety after prenatal cardiac diagnosis and improve neurodevelopmental outcomes for infants with single ventricle CHD. GPS stands for: Guiding through emotions, Providing information and support, and Strengthening connections. The intervention includes sessions with a trained psychologist, coupled with tailored educational resources, and a personalized care plan to support longer-term parent, child, and family wellbeing.

    Treatment: HeartGPS

  • Usual Fetal Cardiac Care (Control Arm)No study treatment, for comparison

    In the usual care arm, participants will receive the information, support, and resources currently offered by their fetal heart care team. This can include support from their doctor or nurse, a social worker, psychologist, or support group, as well as information booklets, websites, and other resources to help parents learn more about their baby's heart condition.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
20 July 2025