Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects in Denmark
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,800
- 试验地点
- 1
- 主要终点
- Psychiatric diagnosis
研究概览
简要总结
The aim of the Mind the Heart study is to document the feasibility of an online parent/child administered screening model for mental disorders (MDs) in Danish children and adolescents with congenital heart disease (CHD). As MDs in children and adolescents with chronic somatic health issues are frequently underdiagnosed and undertreated, we further aim to develop a website with evidence based information on mental health in children and adolescents with CHD in order to promote knowledge and awareness among families and health professionals across sectors.
详细描述
Background:
CHD affects approximately 6-10 children per 1000 live births. Innovations in somatic treatment during the last 50 years have increased survival in children with CHD, but also showed a higher risk of cognitive disabilities and MDs like depression, ADHD and autism in children and adolescents with CHD compared to the general population. Untreated childhood MDs may have serious implications for the child's social and academic functioning, quality of life, future health and employment.
Methods:
Danish children and adolescents diagnosed with CHD (N ~ 4800) will be identified through Danish national registries. Parents to eligible children and adolescents will complete bespoke online questionnaires on sociodemographic factors and received psychological support for their children.
Our initial plan was to use the SDQ and DAWBA set-up for the entire CHD group, but based on the low participation rates in the first two CHD groups (the Fontans and ASDs) the set-up was simplified.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born with a Congenital Heart Defect
- •Age 5-17y
- •(Living in Denmark)
排除标准
- •Younger than 5years of age
- •Older than 17years of age
- •Lacking sufficient Danish language skills to answer the questionnaire
结局指标
主要结局
Psychiatric diagnosis
时间窗: Day 1
Number of participants fulfilling the ICD-10/DSM-5 criteria for a psychiatric diagnosis based on the DAWBA.
Emotional and behavioral difficulties
时间窗: Day 1
SDQ results will be compared to Danish normative data.
次要结局
- Feasibilty(Day 1)
- Unmet mental health needs(Day 1)
研究者
Sara Hirani Lau-Jensen
Principal Investigater
Rigshospitalet, Denmark