Psychological Intervention for Parents of Babies with Congenital Heart Defects

(HeartGPS Trial)

Recruiting at 4 trial locations

Overseen By James F. Cnota, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: DiGeorge syndrome, Untreated psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called HeartGPS, designed to support parents expecting a baby with single ventricle congenital heart disease (SVCHD), a serious heart condition detected before birth. The program includes sessions with a psychologist and special resources to help parents manage stress and bond with their baby. Researchers aim to determine if HeartGPS can improve parents' mental health and their baby's brain development. Pregnant individuals expecting a baby diagnosed with SVCHD between 16 and 30 weeks of pregnancy might be suitable for this study. As an unphased trial, this study offers a unique opportunity for parents to access specialized support and contribute to research that could benefit future families facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that prenatal administration of corticosteroids for fetal lung maturation will be recorded but is not a reason for exclusion.

What prior data suggests that the HeartGPS intervention is safe for parents?

Research has shown that programs like HeartGPS are generally safe for parents expecting babies with heart defects. Similar programs, such as HEARTPrep, have proven safe and well-received by mothers in similar situations. This suggests that HeartGPS is likely to be well-tolerated as well. HeartGPS aims to help parents manage stress and connect with their babies through support from psychologists and personalized resources. While the study examines HeartGPS's effectiveness, existing evidence suggests it is a safe option to consider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

HeartGPS is unique because it combines psychological support with virtual technology to help parents of babies with congenital heart defects. Unlike standard care, which mainly offers general information and support, HeartGPS provides personalized sessions with a psychologist and a tailored care plan. This approach not only aims to reduce maternal stress and anxiety but also focuses on improving the child's neurodevelopmental outcomes, making it a comprehensive support system for the whole family. Researchers are excited about HeartGPS because it leverages user-centered design to create a more interactive and supportive experience for families facing these challenging diagnoses.

What evidence suggests that the HeartGPS intervention is effective for parents of babies with congenital heart defects?

Research shows that parents of babies with a congenital heart defect often experience significant stress and anxiety. Studies have found that psychological support can help reduce these feelings. In this trial, participants in the HeartGPS treatment arm will receive a novel psychological intervention designed to help parents manage their emotions, provide information, and facilitate connections with others. The goal is to improve parents' mental health and support their bonding with their baby. Although specific data on HeartGPS remains limited, early results from similar programs suggest that such interventions can positively affect both parents and their babies, enhancing the overall wellbeing of the family. ^{2 4 5 6 7}

Who Is on the Research Team?

Nadine A Kasparian, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Pregnant person is planning to continue with the pregnancy

I am pregnant with a baby diagnosed with a specific heart condition.

My unborn baby was diagnosed with single ventricle CHD between 16 and 30 weeks of pregnancy.

Exclusion Criteria

My unborn baby has been diagnosed with a condition that could affect their brain development.

Surrogate for pregnancy

Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation

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 psychological intervention during pregnancy, including 8 sessions with a psychologist and tailored educational resources

8 weeks

8 sessions (virtual)

Postpartum Assessment

Maternal and infant assessments are conducted at approximately infant age 28 days, 6 months, and 12 months, including neuroimaging and saliva sampling

12 months

3 visits (in-person)

Follow-up

Participants are monitored for maternal psychological distress and infant neurodevelopmental outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• HeartGPS

Trial Overview 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.

How Is the Trial Designed?

Group I: HeartGPS (Treatment Arm) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Sydney Children's Hospitals Network

Collaborator

Trials

37

Recruited

43,300+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06175104

HeartGPS: A Study Exploring the Effects of a Psychological ... Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal ...

2. trialx.com trialx.com/clinical-trials/listings/319846/heartgps-a-study-exploring-the-effects-of-a-psychological-intervention-for-parents-and-their-babies-after-prenatal-cardiac-diagnosis/

HeartGPS: A Study Exploring the Effects of a Psychological ... The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant ...

3. withpower.com withpower.com/trial/psychological-intervention-for-parents-of-babies-with-congenital-heart-defects-b6474

Psychological Intervention for Parents of Babies with ... Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12384161/

Parental Psychological Response to Prenatal Congenital ... Psychological stress, Parents of prenatally diagnosed infants with CHD had lower anxiety and stress than those diagnosed postnatally after adjusting for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6103210/

Parental Stress and Resilience in Congenital Heart Disease This paper provides a thorough synthesis of the current literature on parental stress addressing disparities in parents of children with CHD.

6. ahajournals.org ahajournals.org/doi/10.1161/HCQ.0000000000000110

Psychological Outcomes and Interventions for Individuals ... This American Heart Association scientific statement summarizes the psychological outcomes of patients with congenital heart disease across the life span

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10531545/

Impact of Prenatal and Postnatal Diagnosis on Parents Parents experience a variety of psychological problems. This article summarizes the influence of CHD in the psychological and economic areas.