HeartGPS for Mothers of Infants With Heart Defects
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a two-arm, prospective, longitudinal, randomized controlled trial (RCT) that will compare usual care to usual care plus a prenatally initiated, virtually administered psychological intervention, called HeartGPS.
Who Is on the Research Team?
Nadine Kasparian, PhD, PMH-C, FAHA
Principal Investigator
Cincinatti Children's Hospital
Are You a Good Fit for This Trial?
This trial is for pregnant women or new mothers whose baby has been diagnosed with a serious heart defect (CHD) between 16 and 30 weeks of pregnancy, where the baby will need heart surgery or a procedure soon after birth. Participants must be carrying one baby, plan to continue the pregnancy and treatment, and speak English or Spanish.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Prenatal Intervention
Participants receive the HeartGPS intervention, which includes eight virtually administered counseling sessions, tailored educational resources, and a mental health care plan
Postpartum Follow-up
Participants are monitored for maternal mental health and infant development outcomes
What Are the Treatments Tested in This Trial?
Interventions
- HeartGPS
Trial Overview
The study compares standard care alone versus standard care plus HeartGPS—a virtual psychological support program started during pregnancy—for mothers of babies with CHD. Participants are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Usual Fetal Cardiac Care + HeartGPS intervention. GPS stands for Guiding parents through emotions, Providing information and support, and Strengthening connections. The HeartGPS intervention includes three key components tailored to the CHD population: 1. Eight virtually administered counseling sessions, 2. Tailored educational resource, 3. Mental health care plan.
This is standard of care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carelon Research
Lead Sponsor
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