No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Children's Hospital Medical Center, Cincinnati · Other
Who this trial is looking for
This trial is looking for pregnant individuals who are carrying a baby diagnosed with a specific heart condition. Participants will attend sessions with a psychologist and receive resources to help manage stress and improve bonding with their baby.
Are You a Good Fit for This Trial?
You may be able to join if
I am pregnant with a fetus diagnosed with single ventricle congenital heart disease.
My baby's heart condition was diagnosed between 16 and 30 weeks of pregnancy.
I am having a singleton pregnancy.
I plan to continue with my pregnancy.
I can participate and complete assessments in English.
You may not be able to join if
My fetus has a condition that would harm brain development.
My medical condition means I cannot safely participate in the study.
I have an untreated major psychiatric condition or substance use disorder.
I have a moderate to severe intellectual disability.
I am under 18 years old.
I am a surrogate for this pregnancy.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 w…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria
1. Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
2. Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
3. Singleton pregnancy.
4. Pregnant person is planning to continue with the pregnancy.
5. Pregnant person is ab…
Inclusion Criteria
1. Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
2. Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
3. Singleton pregnancy.
4. Pregnant person is planning to continue with the pregnancy.
5. Pregnant person is able to participate and complete study assessments in English.
Exclusion Criteria
1. Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
2. Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
3. 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.
4. Parent with a moderate to severe intellectual disability.
5. Parent age \<18 years.
6. Surrogate for pregnancy.
Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
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