HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
Study Details
Study Description
Brief Summary
Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. While prenatal diagnosis can be beneficial for the infant in that it facilitates medical care immediately following birth, mothers describe their prenatal experiences as highly stressful and traumatic. 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 recruitment into HEARTPrep and delivery of this novel intervention 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. While prenatal diagnosis can be beneficial for the infant in that it facilitates medical care immediately following birth, mothers describe their prenatal experiences as highly stressful and traumatic. 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, our team designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. HEARTPrep will be delivered in English and Spanish through the Nemours App, an accessible tool for telehealth and patient education. We aim to (Aim 1) examine the feasibility of enrolling mothers expecting a baby with CHD into a psychosocial intervention trial and identify barriers and facilitators to recruitment, (Aim 2) evaluate initial acceptability and feasibility of HEARTPrep for mothers expecting a baby with CHD and determine if and how intervention elements should be individualized to address diverse family needs, and (Aim 3) explore whether HEARTPrep produces clinically significant improvements on outcomes. 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: HEARTPrep HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD and their partners. 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
HEARTPrep is a virtually-delivered psychosocial intervention for mothers expecting a baby with CHD and their partners.
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Outcome Measures
Primary Outcome Measures
- HEARTPrep Evaluation Questionnaire - During Intervention [Week 6]
Assesses perceived acceptability and feasibility of HEARTPrep
- HEARTPrep Evaluation Questionnaire - Post Intervention [Week 12 (Post-Intervention)]
Assesses perceived acceptability and feasibility of HEARTPrep
- Change in Emotional Distress - PROMIS Short-Form [Week 0 (Baseline), Week 4, Week 8, Week 12 (Post-intervention)]
Assesses change from baseline in feelings of anxiety, depression, and anger
- Change in Social Isolation - PROMIS Short-Form [Week 0 (Baseline), Week 4, Week 8, Week 12 (Post-intervention)]
Assesses change from baseline in feelings of social isolation
- Change in Parenting Self-Efficacy - PROMIS Short-Form [Week 0 (Baseline), Week 4, Week 8, Week 12 (Post-intervention)]
Assesses change from baseline in feelings of parenting self-efficacy
Secondary Outcome Measures
- Change in Hope - PROMIS Short-Form [Week 0 (Baseline), Week 4, Week 8, Week 12 (Post-intervention)]
Assesses change from baseline in feelings of hope
Eligibility Criteria
Criteria
Inclusion Criteria:
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Expectant mothers carrying a fetus with congenital heart disease expected to require cardiac surgery in the first year of life
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Partners of participating expectant mothers can also participate together with the mother
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Receiving fetal cardiac care at Nemours Children's Health
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Speaks English or Spanish fluently
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Age 18 or older
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Nemours Children's Clinic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1813613