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Psychological Intervention for Parents of Babies with 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

Must not have

Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome)

Parent with a moderate to severe intellectual disability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up infant corrected-age 12 months (approximate)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am a parent with a significant intellectual challenge.

Select...

I am a parent and I am under 18 years old.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and infant corrected-age 12 months (approximate) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maternal anxiety symptoms

Maternal depressive symptoms

Maternal traumatic stress symptoms

Secondary study objectives

Infant neurobehavior

Infant neurodevelopment

Mother-infant dyadic synchrony

Other study objectives

Structural and functional brain development

Variation of cortisol levels in maternal and infant saliva

Variation of prenatal cortisol levels in maternal saliva

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met