← Back to Search

Psychological Intervention for Parents of Babies with Congenital Heart Defects (HeartGPS Trial)

N/A
Waitlist Available
Led By Nadine A. Kasparian, PhD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD)
Be older than 18 years old
Must not have
Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome)
Parent with a moderate to severe intellectual disability
Timeline
Screening 3 weeks
Treatment Varies
Follow Up infant corrected-age 12 months (approximate)
Awards & highlights

Summary

This trial will study HeartGPS, a psychological intervention for parents of babies with SVCHD, to see if it helps parents adjust and bond with their baby. It will also look at effects on fetal/infant brain development & neurodevelopmental outcomes.

Who is the study for?
This trial is for parents expecting a baby diagnosed with single ventricle congenital heart disease (SVCHD) during pregnancy. They are looking to support these parents by providing psychological help and education, aiming to improve their wellbeing and ability to bond with their baby.
What is being tested?
The HeartGPS intervention includes 8 sessions with a psychologist, educational materials, and a personalized care plan. It's being tested to see if it helps reduce parental stress, anxiety, depression; improves parent-infant bonding; and benefits the baby's brain development and neurodevelopmental outcomes.
What are the potential side effects?
Since HeartGPS is a psychological intervention rather than a drug or medical procedure, there may not be physical side effects. However, discussing sensitive topics could potentially cause emotional discomfort or distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am pregnant with a baby diagnosed with a specific heart condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My unborn baby has been diagnosed with a condition that could affect their brain development.
Select...
I am a parent with a significant intellectual challenge.
Select...
I am a parent and I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~infant corrected-age 12 months (approximate)
This trial's timeline: 3 weeks for screening, Varies for treatment, and infant corrected-age 12 months (approximate) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maternal anxiety symptoms
Maternal depressive symptoms
Maternal traumatic stress symptoms
Secondary study objectives
Infant neurobehavior
Infant neurodevelopment
Mother-infant dyadic synchrony
Other study objectives
Structural and functional brain development
Variation of cortisol levels in maternal and infant saliva
Variation of prenatal cortisol levels in maternal saliva

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HeartGPS (Treatment Arm)Experimental Treatment1 Intervention
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.
Group II: Usual Fetal Cardiac Care (Control Arm)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Sydney Children's Hospitals NetworkOTHER
36 Previous Clinical Trials
43,246 Total Patients Enrolled
University of PittsburghOTHER
1,762 Previous Clinical Trials
16,347,899 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
888 Previous Clinical Trials
934,830 Total Patients Enrolled
~69 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top