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

104 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment HeartGPS for parents of babies with congenital heart defects?

Research shows that similar programs, like the Family Coping Project and HEARTPrep, have helped parents feel less stressed and more capable of handling their child's heart condition. These programs increased parents' confidence in coping and were well-received, suggesting that HeartGPS might also be effective. ^{1 2 3 4 5}

Is the psychological intervention for parents of babies with congenital heart defects safe?

The HEARTPrep program, a similar psychological intervention, was found to be safe and well-received by mothers expecting a baby with congenital heart disease, with high enrollment and completion rates, and positive feedback on reducing distress and increasing preparedness. ^{2 3 5 6 7}

How does the psychological intervention for parents of babies with congenital heart defects differ from other treatments?

This psychological intervention is unique because it focuses on reducing stress and improving mental health for parents of babies with congenital heart defects, which is not typically addressed in standard medical care. It is delivered virtually, making it accessible and convenient for parents, and aims to enhance their coping skills and emotional well-being, which can positively impact the entire family. ^{3 5 8 9 10}

What is the purpose of this trial?

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. 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 cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

Research Team

Nadine A Kasparian, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Enhancing Parental Coping with a Child's Heart Condition: A Co-production Pilot Study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Birth of a child with congenital heart disease: emotional reactions of mothers and fathers according to time of diagnosis. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Virtually Delivered Psychosocial Intervention for Prenatally Diagnosed Congenital Heart Disease: Feasibility and Acceptability of HEARTPrep. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Parent Perspectives on Family-Based Psychosocial Interventions for Congenital Heart Disease. [2021]

5. England pubmed.ncbi.nlm.nih.gov

"There's no acknowledgement of what this does to people": A qualitative exploration of mental health among parents of children with critical congenital heart defects. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Parent-child bonding and attachment during pregnancy and early childhood following congenital heart disease diagnosis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A multicentric study of disease-related stress, and perceived vulnerability, in parents of children with congenital cardiac disease. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Psychological distress in parents of children with severe congenital heart disease: the impact of prenatal versus postnatal diagnosis. [2007]

9. England pubmed.ncbi.nlm.nih.gov

Parenting Stress in Parents of Infants With Congenital Heart Disease and Parents of Healthy Infants: The First Year of Life. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Long-term psychological distress, and styles of coping, in parents of children and adolescents who underwent invasive treatment for congenital cardiac disease. [2022]