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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
30
HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD.
Nemours Children's Health
Wilmington, Delaware, United States
Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
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.
Time frame: Weeks 1, 2, 3, 4, 6
Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
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.
Time frame: Weeks 1, 2, 3, 4, 6
Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
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.
Time frame: Weeks 1, 2, 3, 4, 6
Self-Efficacy Short-Form
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)
Time frame: Weeks 1, 2, 3, 4, 6
Hope Short-Form
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)
Time frame: Weeks 1, 2, 3, 4, 6
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