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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Behavioral: HEARTPrep


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEARTPrep<br>HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HEARTPrep consists of three distinct modules: Adjusting, Connecting, and Preparing. Each module targets one distinct primary outcome (emotional distress, social isolation, parenting self-efficacy) and a common secondary outcome (hope) through a suite of evidence-based intervention elements (e.g., psychoeducation, cognitive restructuring, mindfulness) for addressing emotional problems in other populations, including pregnant women. HEARTPrep elements include: a) telehealth with a psychosocial provider, b) recorded videos, c) educational tools, and d) links to resources. | Behavioral: HEARTPrep<br>* HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HEARTPrep Evaluation Questionnaire - Session 3 | Assesses perceived acceptability and feasibility of HEARTPrep (item responses range from 0-4 with higher scores reflecting greater acceptability and feasibility; minimum score = 0; maximum score = 64) | 6 weeks (Session 3) | 
| HEARTPrep Evaluation Questionnaire - Session 6 | Assesses perceived acceptability and feasibility of HEARTPrep (item responses range from 0-4 with higher scores reflecting greater acceptability and feasibility; minimum score = 0; maximum score = 64) | 12 weeks (Session 6) | 
| Change in Emotional Distress - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form | Assesses change from baseline in feelings of anxiety and depression (item responses range from 1-5 with higher scores reflecting greater emotional distress; minimum score = 4; maximum score = 20) | Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 
| Change in Social Isolation - PROMIS Short-Form | Assesses change from baseline in feelings of social isolation (item responses range from 1-5 with higher scores reflecting greater social isolation; minimum score = 4; maximum score = 20) | Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 
| Change in Parenting Self-Efficacy - PROMIS Short-Form | Assesses change from baseline in feelings of parenting self-efficacy (item responses range from 1-5 with lower scores reflecting lower parenting self-efficacy; minimum score = 4; maximum score = 20) | Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hope - PROMIS Short-Form | Assesses change from baseline in feelings of hope (item responses range from 1-5 with lower scores reflecting lower hope; minimum score = 4; maximum score = 20) | Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |