HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease

Last updated: June 30, 2025
Sponsor: Nemours Children's Clinic
Overall Status: Completed

Phase

N/A

Condition

Congenital Heart Disease

Heart Disease

Pentalogy Of Cantrell

Treatment

HEARTPrep

Clinical Study ID

NCT05129631
1813613
  • Ages > 18
  • All Genders

Study Summary

Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. In partnership with diverse parent and clinician stakeholders, our team designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. This project will pilot HEARTPrep with mothers expecting a baby with CHD to obtain preliminary data for a larger future trial. This intervention has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Expectant mothers carrying a fetus with congenital heart disease expected to requirecardiac surgery in the first year of life

  • Partners of participating expectant mothers can also participate together with themother

  • Receiving fetal cardiac care at Nemours Children's Health

  • Speaks English or Spanish fluently

  • Age 18 or older

  • Access to a computer, tablet or mobile device with internet access

Exclusion

Exclusion Criteria:

-Fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: HEARTPrep
Phase:
Study Start date:
July 14, 2023
Estimated Completion Date:
May 31, 2025

Study Description

Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. Targeted efforts to mitigate impacts of maternal stress for this highly vulnerable population are lacking. In partnership with diverse parent and clinician stakeholders, the investigators designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HEARTPrep will be delivered through the Nemours App, an accessible tool for telehealth and patient education. The investigators aim to determine whether HEARTPrep modules produce clinically significant improvements on outcomes in mothers expecting a baby with CHD (Proof-of-Concept). This program of research has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.

Connect with a study center

  • Nemours Children's Health

    Wilmington, Delaware 19803
    United States

    Site Not Available

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