HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- HEARTPrep Evaluation Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Fetus has a genetic syndrome or other comorbid condition associated with a life expectancy of less than one year
研究组 & 干预措施
HEARTPrep
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.
干预措施: HEARTPrep (Behavioral)
结局指标
主要结局
HEARTPrep Evaluation Questionnaire
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
Depression - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
时间窗: 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.
Anxiety - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
时间窗: 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.
Social Isolation - Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form
时间窗: 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.
次要结局
- Change in Hope - PROMIS Short-Form(Weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- Self-Efficacy Short-Form(Weeks 1, 2, 3, 4, 6)
- Hope Short-Form(Weeks 1, 2, 3, 4, 6)
研究者
Erica Sood
Pediatric Psychologist
Nemours Children's Clinic