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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Fetal neuroimaging will occur at approximately 36-weeks gestation and infant neuroimaging will take place at approximately infant age 28-days, using structural and functional magnetic resonance imaging (MRI)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

HeartGPS tests a support program for parents who learn during pregnancy that their baby has a heart defect with only one working pumping chamber. The program adds 8 sessions with a psychologist, learning materials, and a personal care plan to usual care. The study looks at parents’ mental health, bonding with their baby, and the baby’s brain growth and development.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are pregnant with a baby diagnosed with single ventricle heart disease, a heart defect with only one working pumping chamber.
  • The baby’s heart condition was diagnosed between 16 and 30 weeks of pregnancy.
  • You are carrying one baby.
  • You plan to continue the pregnancy.
  • You can take part in the study and complete its assessments in English.

Who can't join

  • The baby has another condition expected to harm brain development, such as DiGeorge syndrome.
  • You or the baby have a medical condition that your treating doctor says makes study participation unsafe or unsuitable.
  • A parent has an untreated serious mental health condition, a drug or alcohol use disorder, or other circumstances that prevent safe or full participation.
  • A parent has a moderate to severe intellectual disability, which limits learning and everyday skills.
  • A parent is younger than 18.
  • You are carrying the pregnancy as a surrogate for someone else.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

CA

OH