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

NCT05129631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-03

No results posted yet for this 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.

Conditions

  • Congenital Heart Disease

Interventions

BEHAVIORAL

HEARTPrep

HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD.

Sponsors & Collaborators

  • Nemours Children's Clinic

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05129631 on ClinicalTrials.gov