Interdisciplinary, E-health Based, Multimodal Follow-up of Somatic, Sleep-related and Psychological Symptoms of Very Immature Preterm Born Babies in Different Age Groups for the Further Development of Previous Care Structures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Youth Self Report (YSR)
研究概览
简要总结
The aim of the study is to assess mental and somatic symptoms of preterm born children at the ages of 2, 5 and 10 by a multidisciplinary team and to evaluate an app that screens for these symptoms. Furthermore, there will be an evaluation of an intervention by our multidisciplinary team that provides recommendations for further treatment and diagnostic procedures of the children.
详细描述
- At first, there will be focus groups with experts and affected families to finalize and optimize the study procedure. After that, 90 children will be recruited (ages 2, 5 and 10)
- T0: App-questions for the children at the ages of 5 and 10 and the parents of all children to mental, somatic and sleep problems of the children and well-being of the parents, sleep tracking and recording of a sleep sequence of the children; differentiated examinations and questionnaires to mental and somatic problems of the children by interdisciplinary study team
- Interdisciplinary study team meeting to generate recommendations for the families
- Interdisciplinary study team recommendations for the families
- T1: Comparable to T0 but only measurements that were assessed with questionnaires/at home plus post-experimental questionnaire
- Focus groups with participating families and the study team experts for evaluation of the study procedure and intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •female and male preterm born children (<32 week of pregnancy) that are treated at the clinic in Tübingen and their parents
- •Existence of systematical neonatal data and consent of the care person to use this data
- •Existence of the data of the 2 year regular follow-up (for the 5 and 10 year olds)
排除标准
- •lack of access to a mobile phone/tablet including internet access
- •insufficient knowledge of the German language of both parents
研究组 & 干预措施
Diagnostic assessments and intervention
All families get a diagnostics and intervention recommendations.
干预措施: Diagnostics and intervention recommendations (Other)
结局指标
主要结局
Youth Self Report (YSR)
时间窗: Baseline and 36-38 weeks after baseline
Screening for mental illness
Bayley Scales of Infant and Toddler Development
时间窗: Baseline
IQ testing
Sleep Self Report (SSR)
时间窗: Baseline and 36-38 weeks after baseline
Screening of sleeping behaviour
Child Behavior Checklist (CBCL)
时间窗: Baseline and 36-38 weeks after baseline
Screening for mental illness
Parent's Stress Inventory (EBI)
时间窗: Baseline and 36-38 weeks after baseline
Load as parents and relationship to the child
KIDSCREEN-27 (The KIDSCREEN)
时间窗: Baseline and 36-38 weeks after baseline
Health related quality of life
Wechsler Intelligence Scale for Children (WISC-V)
时间窗: Baseline
IQ testing
Somatics
时间窗: Baseline and 36-38 weeks after baseline
Questions to somatic symptoms (diagnoses, inpatient stays, medication, early support) physical therapy, hearing impairment or visual disturbance, pulmonary symptoms, seizure disorders, health related quality of life, body weight, size)
App-questions
时间窗: Baseline and 36-38 weeks after baseline
Questions reflecting the questionnaires
Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)
时间窗: Baseline and 36-38 weeks after baseline
Screening of sleeping behaviour
Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB)
时间窗: Baseline and 36-38 weeks after baseline
Screening for mental illness
Postexperimental questionnaire
时间窗: 36-38 weeks after baseline
Evaluation of the study
次要结局
- Actigraphy measurement(Baseline)
- Sleep cartoon for children(Baseline and 36-38 weeks after baseline)
- Video of a sleeping sequence(Baseline)
- Demographic data(Baseline)
- Kiddie-Sads-Present and Lifetime Version (K-SADS PL)(Baseline)
- Self efficacy dealing with social situations (WIRKSOZ)(Baseline and 36-38 weeks after baseline)
- Group interviews(Baseline and 36-38 weeks after baseline)
研究者
PD Dr. Annette Conzelmann
Principal Investigator
University Hospital Tuebingen