HeartGPS for Mothers of Infants With Congenital Heart Disease

Prenatally-initiated Psychological Intervention for Mothers of Infants With Congenital Heart Disease (CHD)

Recruiting N/A Interventional Study
Congenital Heart Disease (CHD)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

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.

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About This Trial

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…
Contacts

Stephanie Lynch, MPH

339-368-9294

stephanie.lynch@carelon.com

CONTACT

Julie E Miller, MPH

7812274645

julie.miller2@carelon.com

CONTACT