Actively Recruiting
HeartGPS: A Longitudinal Randomized Trial Examining a Prenatal Psychological Intervention for Parents and Their Babies With Single Ventricle Congenital Heart Disease
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2025-07-20
50
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
C
Children's Hospital Los Angeles
Collaborating Sponsor
AI-Summary
What this Trial Is About
Babies diagnosed prenatally with single ventricle congenital heart disease (SVCHD) often face challenges due to prenatal stress experienced by their parents. This research evaluates a psychological intervention called HeartGPS designed to support parents who receive this diagnosis during pregnancy. The study aims to understand whether adding HeartGPS to usual fetal cardiac care helps reduce parental anxiety, depression, and traumatic stress, while also examining effects on fetal and infant brain development, parent-infant bonding, and infant neurodevelopment. The trial is a longitudinal randomized controlled study involving multiple sites and enrolling mothers expecting babies with SVCHD. The HeartGPS intervention includes eight sessions with a trained psychologist, delivered either in-person or via telehealth, combined with tailored educational materials and a personalized care plan to promote mental health and parent-child bonding. Participants are randomly assigned to receive either usual fetal cardiac care alone or usual care plus the HeartGPS program. The intervention spans the prenatal period and early postpartum, focusing on emotional support and strategies for coping and communication. Participants will undergo assessments before and after the intervention, including maternal psychological evaluations at baseline, around 36 weeks gestation, and during the first year postpartum. Fetal and infant brain imaging using MRI will occur near 36 weeks gestation and around 28 days after birth. Biological samples from parents and infants will also be collected. Researchers will measure maternal anxiety, depression, and traumatic stress as primary outcomes, alongside infant neurobehavior, neurodevelopment, and mother-infant interaction. The study monitors participants for up to 12 months after birth to assess long-term effects.
CONDITIONS
Brief Title
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD)
- Diagnosis made between 16 and 30 weeks gestation
- Singleton pregnancy
- Planning to continue with the pregnancy
- Able to participate and complete study assessments in English
You will not qualify if you...
- Fetus with a comorbid condition expected to adversely impact neurodevelopment (e.g., DiGeorge Syndrome)
- Fetal or maternal medical condition deemed contraindicated by physician
- Parent with untreated major psychiatric condition or substance use disorder interfering with safe participation
- Parent with moderate to severe intellectual disability
- Parent younger than 18 years
- Surrogate for pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or virtual)
Duration - 8 weeks during pregnancy and early postpartum
Participants receive the HeartGPS psychological intervention during pregnancy and the early postpartum period. The intervention includes sessions with a psychologist, educational resources, and a personalized care plan to support parent and infant mental health and wellbeing.
Weekly sessions with a psychologist (in-person or via telehealth)
Duration - From baseline (pre-randomization) through infant age 12 months
Participants undergo maternal and infant assessments including neuroimaging and collection of biological samples to evaluate psychological distress and infant neurodevelopment.
5 assessment visits approximately at baseline, 36 weeks gestation, infant age 28 days, 6 months, and 12 months
Trial Site Locations
Total: 4 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Not Yet Recruiting
2
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, United States, 45229
Actively Recruiting
3
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Not Yet Recruiting
4
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
Research Team
N
Nadine A. Kasparian, PhD
J
James F. Cnota, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here