HeartGPS A Prenatal Psychological Support Program for Parents of Babies with Single Ventricle Congenital Heart Disease A Study to Improve Parent Wellbeing and Infant Brain Development

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.

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