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

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Dec 8, 2023

Keywords

ClinConnect Summary

The HeartGPS trial is studying how a special support program can help parents who learn that their baby has a serious heart condition called single ventricle congenital heart disease (SVCHD) during pregnancy. This program includes eight sessions with a psychologist, along with personalized educational materials and care plans. The goal is to help parents manage their feelings, such as anxiety and depression, while also encouraging a strong bond with their baby. Researchers will see if this support makes a difference in how parents feel, how their baby's brain develops, and the overall well-being of both the parents and the baby.

To be eligible for this study, a pregnant person must be carrying a baby diagnosed with SVCHD between 16 and 30 weeks of pregnancy, be planning to continue with the pregnancy, and be able to participate in the study in English. Participants will receive psychological support in addition to standard medical care for their baby's heart condition. This study is not yet recruiting, but it aims to gather valuable information about how this kind of support can help families cope during a challenging time.

Gender

ALL

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.