HeartGPS: Prenatal mental health support for mothers of babies with CHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is part of the BOND platform, a randomized trial testing a prenatally started, online psychological intervention added to usual care for families affected by CHD. Eligible participants include pregnant individuals carrying a fetus with CHD or mothers of newborns with CHD who will need surgical or catheter-based treatment in the first month. The trial uses a two‑arm design to compare usual care alone versus usual care plus HeartGPS, with outcomes focused on maternal mental health and infant development. It is conducted at three children’s hospitals in the U.S., with English or Spanish language options for participation. The intervention is delivered virtually and aims to support parent wellbeing during the prenatal and early postnatal period.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• University of Michigan Health System, Ann Arbor
  Ann Arbor, Michigan, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• Le Bonheur Children's Hospital
  Memphis, Tennessee, United States Recruiting
• Phoenix Children's Hospital
  Phoenix, Arizona, United States Not yet recruiting

Study contacts

• Study coordinator: Stephanie Lynch, MPH
• Email: stephanie.lynch@carelon.com
• Phone: 339-368-9294

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.