HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease
- Sponsor
- Nemours Children's Clinic
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- HEARTPrep Evaluation Questionnaire
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Erica Sood
Pediatric Psychologist
Nemours Children's Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
HEARTPrep Evaluation Questionnaire
Time Frame: Post-intervention
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)
Change in Emotional Distress - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
Time Frame: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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)
Change in Social Isolation - PROMIS Short-Form
Time Frame: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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)
Change in Parenting Self-Efficacy - PROMIS Short-Form
Time Frame: Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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)
Secondary Outcomes
- Change in Hope - PROMIS Short-Form(Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)