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HeartGPS (Treatment Arm) for 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up infant corrected-age 12 months (approximate)
Awards & highlights
HeartGPS Trial 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.Check my eligibility
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.See study design
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.
HeartGPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am pregnant with a baby diagnosed with a specific heart condition.
HeartGPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ infant corrected-age 12 months (approximate)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~infant corrected-age 12 months (approximate)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maternal anxiety symptoms
Maternal depressive symptoms
Maternal traumatic stress symptoms
Secondary outcome measures
Infant neurobehavior
Infant neurodevelopment
Mother-infant dyadic synchrony
Other outcome measures
Structural and functional brain development
Variation of cortisol levels in maternal and infant saliva
Variation of prenatal cortisol levels in maternal saliva
HeartGPS 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.
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Who is running the clinical trial?
Sydney Children's Hospitals NetworkOTHER
35 Previous Clinical Trials
43,142 Total Patients Enrolled
University of PittsburghOTHER
1,725 Previous Clinical Trials
16,305,697 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
858 Previous Clinical Trials
672,189 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are multiple institutions in North America currently conducting this research?
"Five healthcare facilities are currently enrolling participants for this trial, including Children's Hospital Los Angeles in California, Sydney Children's Hospital in Randwick, and Monroe Carell Jr. Children's Hospital at Vanderbilt in Nashville. Additionally there are two other medical sites participating as well."
Answered by AI
Are there any enrollment opportunities available for this clinical trial?
"As indicated on clinicaltrials.gov, recruitment for this trial has been halted since December 8th 2023 and it was initially posted on January 1st 2024. However, there are still 389 other studies that need participants right now."
Answered by AI
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