NCT06175104 · Children's Hospital Medical Center, Cincinnati
HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis
(HeartGPS)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
HeartGPS
HeartGPS includes three key components: 1. Sessions with a psychologist trained to deliver the intervention using attachment-based and trauma-informed therapy techniques, coupled with mind-body skills. The intervention can be delivered in-person or via telehealth, in accordance with participants' preferences. 2. Educational resources, including a series of modules to complement the sessions and evidence-based tools to support psychological adjustment and coping, parent-infant bonding and attachment, and parent-clinician communication. 3. A personalized care plan, charting mental health care needs, goals, and preferences, with evidence-based strategies to support longer-term wellbeing.
Primary outcome measures
Maternal anxiety symptoms
Time frame: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)
Maternal anxiety symptoms will be measured using the validated, 20-item, self-report State-Trait Anxiety Inventory State subscale. Response options for each item range from 1 ('Not at all') to 4 ('Very much so'), yielding a total possible score ranging from 20 to 80, with higher scores indicating greater anxiety symptoms.
Maternal depressive symptoms
Time frame: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)
Maternal depressive symptoms will be measured using the validated, 10-item, self-report Edinburgh Depression Scale. Response options for each item range from 0 to 3, yielding a total possible score ranging from 0 to 30, with higher scores indicating greater depressive symptoms.
Maternal traumatic stress symptoms
Time frame: Baseline, 36 weeks gestation (approximate), infant corrected-age 28 to 56 days, 4 months postpartum (approximate), and infant age 12 months (approximate)
Maternal traumatic stress symptoms will be measured using the validated, 20-item, self-report Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual of Mental Disorders, 5th edition (DSM-5). Response options for each item range from 0 ('Not at all') to 4 ('Extremely'), yielding a total possible score ranging from 0 to 80, with higher scores indicating greater traumatic stress symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
- Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
- Singleton pregnancy.
- Pregnant person is planning to continue with the pregnancy.
- Pregnant person is able to participate and complete study assessments in English.
Exclusion criteria
- Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
- Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
- Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
- Parent with a moderate to severe intellectual disability.
- Parent age \<18 years.
- Surrogate for pregnancy. Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
Where
- Los Angeles, California
- Cincinnati, Ohio
Collaborators
Children's Hospital Los Angeles, Sydney Children's Hospitals Network
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2025 · Source of record for eligibility and locations