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Completed

NCT Number: NCT05129631

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

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Health

Wilmington, Delaware, 19803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Expectant mothers carrying a fetus with congenital heart disease expected to require cardiac surgery in the first year of life
  • Partners of participating expectant mothers can also participate together with the mother
  • 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 criteria

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

Treatment and study plan

HEARTPrep

Behavioral

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

Primary outcomes

  1. Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form

    Time frame: Weeks 1, 2, 3, 4, 6

    Assesses depression over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater depression. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of depression and a T-score of 70 and above is indicative of a severe level of depression.

  2. Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form

    Time frame: Weeks 1, 2, 3, 4, 6

    Assesses anxiety over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater anxiety. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of anxiety and a T-score of 70 and above is indicative of a severe level of anxiety.

  3. Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form

    Time frame: Weeks 1, 2, 3, 4, 6

    Assesses social isolation over six weeks of HEARTPrep. Item responses range from 1-5 with higher scores reflecting greater social isolation. Raw scores are converted to T-scores, which have a population mean of 50 with a standard deviation of 10. Higher scores represent a worse outcome. A T-score of 60-69 is indicative of a moderate level of social isolation and a T-score of 70 and above is indicative of a severe level of social isolation.

Secondary outcomes

  1. Self-Efficacy Short-Form

    Time frame: Weeks 1, 2, 3, 4, 6

    Assesses feelings of self-efficacy over six weeks of HEARTPrep (item responses range from 1-5 with higher scores reflecting greater self-efficacy; minimum score = 4; maximum score = 20)

  2. Hope Short-Form

    Time frame: Weeks 1, 2, 3, 4, 6

    Assesses feelings of hope over six weeks of HEARTPrep (item responses range from 1-5 with higher scores reflecting greater hope; minimum score = 4; maximum score = 20)

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Acronym: HEARTPrep

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2021
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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