Clinical Trials / Research Studies
A Study for Parents During Pregnancy After Prenatal Diagnosis of Single Ventricle Congenital Heart Disease
Why are we doing this research?
Babies with single ventricle congenital heart disease (CHD) are often diagnosed during pregnancy. For parents and families, learning about your baby’s heart condition during pregnancy is unexpected and stressful, and many parents express a need for support.
Working with families and their heart care teams, we have developed a program that provides psychological support for parents after prenatal diagnosis of single ventricle CHD. We call this program HeartGPS because it helps:
- Guide parents through emotions
- Provide information and support
- Strengthen connections
We designed HeartGPS to ensure parents that they are not alone. The program includes 8 sessions with a psychologist, information resources, and a personalized support plan. The focus is on increasing support and wellbeing, as well as helping parents to bond with their baby in ways that feel right for them.
In this study, we want to learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to their usual fetal cardiac care.
Who can participate?
Pregnant parents who receive a prenatal diagnosis of single ventricle CHD may be eligible to participate. Our team can provide more information about study eligibility and participation.
Conditions
- Pregnancy
- Cardiology/Heart
What will happen in the study?
The study begins in pregnancy and ends when the baby is about 12 months old.
In this study, moms are asked to:
- Fill out online surveys at home
- Provide saliva samples
- Provide a blood sample
- Donate some placental tissue after baby’s birth
- Participate in a scan of baby during pregnancy
- Participate in a short (5 minute) play activity with baby at your heart center
For babies in the study, we will:
- Collect saliva samples at your heart center
- Collect a blood sample
- Assess baby’s development and take a brain scan when they are about 28 days old
- Assess baby’s development when they are about 12 months old
Dads who join the study are asked to:
- Provide a blood sample
- Fill out a short online survey
- Consider taking part in 3 sessions of the HeartGPS program
Parents who choose to take part in this study will be randomly assigned to receive usual care or usual care plus HeartGPS.
What are the good things that can happen from this research?
We hope the knowledge gained through this study will benefit families of babies with CHD in the future. While being in this study may not have immediate benefit, parents who take part will have an important role in developing a better support program for families who follow in their footsteps.
What are the bad things that can happen from this research?
There are minimal risks associated with this study. All possible risks will be discussed with those interested in learning more about the study.
Will you/your child be paid to be in this research study?
Families will receive up to $340 for the time and effort involved in being part of the study.
Contact
HeartGPS Study Team
heartgps@cchmc.org
513-400-3701
Heart and Mind Wellbeing Center
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue Cincinnati, OH 45229-3039
Study Doctor
Nadine Kasparian, PhD, MAPS
Professor, UC Department of Pediatrics
Director, Heart and Mind Wellbeing Center
Heart Institute and Division of Behavioral Medicine and Clinical Psychology
Cincinnati Children's Hospital Medical Center
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3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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