No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
210 (estimated)
Sponsor
Carelon Research · Other
Who this trial is looking for
This trial is looking for pregnant individuals or mothers of infants diagnosed with congenital heart disease (CHD). Participants will receive usual care plus a virtual psychological intervention to help manage their situation.
Are You a Good Fit for This Trial?
You may be able to join if
I am pregnant with a fetus diagnosed with CHD.
I am the mother of an infant diagnosed with CHD.
My baby is expected to need heart surgery in the first month of life.
I am in singleton pregnancy.
I plan to continue my pregnancy and pursue surgery for my baby.
I can participate in the study in English or Spanish.
You may not be able to join if
A doctor says I have a medical condition that prevents me from joining.
I have a severe psychiatric condition or substance use issue.
I have a moderate to severe intellectual disability.
My baby was diagnosed with CHD after birth.
My fetus has a major neurodevelopmental condition.
I am under 18 years old.
I am carrying a surrogate pregnancy.
I answered less than 70% of survey questions at the first assessment.
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.
This is a two-arm, prospective, longitudinal, randomized controlled trial (RCT) that will compare usual care to usual care plus a prenatally initiated, virtually administered psychological intervention, called HeartGPS.
Trial Locations
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Eligibility Criteria
Both mothers and infants are study participants.
Inclusion Criteria:
1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter interven…
Both mothers and infants are study participants.
Inclusion Criteria:
1. Pregnant individual carrying a fetus diagnosed with CHD or biological mother of an infant diagnosed with CHD in the neonatal period.
2. Fetus or newborn with CHD anticipated to require cardiac surgery or transcatheter intervention in the first 30 days of life.
3. CHD diagnosis received between 16.0 and 30.0 weeks gestation.
4. Singleton pregnancy.
5. Pregnant mother is planning to continue the pregnancy and pursue surgical or transcatheter intervention for the infant.
5\. Pregnant mother is able to participate and complete study assessments in English or Spanish.
Exclusion Criteria:
1. Mother, fetal, or infant medical condition determined by a treating clinician to be contraindicative to study participation.
2. Mother with a severe, untreated psychiatric condition, substance use disorder, or other circumstances that, in the opinion of the investigator, would interfere with engagement with study tasks or safe participation in the trial.
3. Mother with a moderate to severe intellectual disability or is otherwise unable to provide informed consent.
4. Postnatal diagnosis of CHD.
5. Fetus with a comorbid condition with a predictable and major impact on neurodevelopment (e.g., Trisomy 21, DiGeorge syndrome).
6. Pregnant individual is aged \<18 years.
7. Pregnant individual is carrying a surrogate pregnancy.
8. Consented mother completes \<70% of survey questions at first (baseline) assessment.
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