210 Participants NeededMy employer runs this trial

HeartGPS for Mothers of Infants With Heart Defects

Recruiting at 16 trial locations
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Overseen ByStephanie Lynch, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Carelon Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support mothers of infants diagnosed with congenital heart defects (CHD) by adding a new program called HeartGPS to their usual care. HeartGPS includes online counseling sessions, personalized educational resources, and a mental health care plan to help mothers navigate the emotional and practical challenges of having a baby with CHD. The study compares the outcomes of mothers receiving only standard care with those who also receive the HeartGPS program. Pregnant individuals carrying a fetus diagnosed with CHD, who plan surgery or intervention within the first month after birth, may be eligible to participate.

As an unphased trial, this study offers a unique opportunity to access additional support and resources that could significantly improve participants' experiences and outcomes.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the HeartGPS intervention is safe?

Research has shown that HeartGPS, a psychological program, helps mothers of babies with heart problems manage stress and anxiety. Specific safety information on HeartGPS is limited because it is a new type of psychological treatment, not a drug or medical device. However, studies on similar programs often find them safe and low-risk, as they focus on counseling and support.

This trial is in the "Not Applicable" phase, indicating that HeartGPS has demonstrated safety in early tests or similar situations and is now being tested in real-life settings. This phase aims to assess its effectiveness and safety for participants. Current information suggests that HeartGPS is likely safe and well-tolerated.12345

Why are researchers excited about this trial?

Researchers are excited about HeartGPS for moms of infants with heart defects because it offers a comprehensive support system that goes beyond traditional care. Unlike standard care, which mainly focuses on the medical needs of the infant, HeartGPS combines emotional support, tailored education, and mental health planning specifically for the parents. This approach aims to guide parents through the emotional challenges, provide tailored information, and strengthen family connections, which can be crucial for overall family well-being. By targeting the parents' needs, HeartGPS hopes to improve the family's ability to manage their child's condition more effectively.

What evidence suggests that the HeartGPS intervention is effective for mothers of infants with heart defects?

Research has shown that HeartGPS, a new psychological program tested in this trial, helps reduce stress and anxiety in mothers of babies with congenital heart defects (CHD). Participants in this trial may receive the HeartGPS intervention, which includes virtual counseling sessions and educational materials tailored for these mothers. Early results suggest that virtual technology and a simple design can help mothers manage their emotions and improve their mental health. Although the data is still developing, the program aims to support mothers by helping them handle emotional challenges, providing important information, and strengthening their support networks.23678

Who Is on the Research Team?

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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

My congenital heart disease was diagnosed between 16 and 30 weeks of pregnancy.
I am pregnant with one baby.
I am pregnant and plan to continue my pregnancy and have surgery or a procedure for my baby.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prenatal Intervention

Participants receive the HeartGPS intervention, which includes eight virtually administered counseling sessions, tailored educational resources, and a mental health care plan

36 weeks gestation
8 virtual sessions

Postpartum Follow-up

Participants are monitored for maternal mental health and infant development outcomes

12 months postpartum
Regular assessments at 1-2 months, 4 months, and 12 months postpartum

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

Group I: HeartGPSExperimental Treatment1 Intervention
Group II: Usual Fetal Cardiac CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carelon Research

Lead Sponsor

Trials
76
Recruited
125,000+

Citations

Exploring Health Educational Interventions for Children ... - PMC

This scoping review aims to map and explore existing health educational interventions for children with CHD.

Public Health Approach to Improve Outcomes for ...

Recent evidence suggests ongoing risk for early mortality, even after repair of less‐severe CHD lesions. Multiple data sets are available and ...

HeartGPS: A Study Exploring the Effects of a Psychological ...

This is a novel psychological intervention leveraging virtual technology and user-centered design to reduce maternal psychological stress and anxiety after ...

Data and Statistics | Congenital Heart Defects (CHDs)

View recent data and statistics on individuals living with heart defects.

Interventions in Congenital Heart Disease: A Review of ...

This article is the second of a two-part review of recent developments in congenital cardiac interventions, including advances in devices and techniques for ...

Recent Advances in the Diagnosis and Management of ... - PMC

The incidence of CHD is roughly 0.8% in live-born babies. Nearly half of these patients may be managed via the administration of drugs, ...

Congenital Heart Defect (CHD) Databases for Surveillance ...

Select databases and registries for studying outcomes for persons with congenital heart defects in the United States.

Neurodevelopmental Outcomes for Individuals With ...

Outcomes after cardiac arrest in children with congenital heart disease are affected by whether the arrest is witnessed, its cause, the quality ...