Interdisciplinary E-health Based Follow-up of Preterm Born Children
- Conditions
- Preterm Birth
- Interventions
- Other: Diagnostics and intervention recommendations
- Registration Number
- NCT06345664
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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.
- Detailed Description
* 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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)
- lack of access to a mobile phone/tablet including internet access
- insufficient knowledge of the German language of both parents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnostic assessments and intervention Diagnostics and intervention recommendations All families get a diagnostics and intervention recommendations.
- Primary Outcome Measures
Name Time Method Youth Self Report (YSR) Baseline and 36-38 weeks after baseline Screening for mental illness
Bayley Scales of Infant and Toddler Development Baseline IQ testing
Sleep Self Report (SSR) Baseline and 36-38 weeks after baseline Screening of sleeping behaviour
Child Behavior Checklist (CBCL) Baseline and 36-38 weeks after baseline Screening for mental illness
KIDSCREEN-27 (The KIDSCREEN) Baseline and 36-38 weeks after baseline Health related quality of life
Wechsler Intelligence Scale for Children (WISC-V) Baseline IQ testing
Somatics 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)
Parent's Stress Inventory (EBI) Baseline and 36-38 weeks after baseline Load as parents and relationship to the child
App-questions Baseline and 36-38 weeks after baseline Questions reflecting the questionnaires
Children's Sleep Habit Questionnaire (CSHQ-DE 4-10) 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) Baseline and 36-38 weeks after baseline Screening for mental illness
Postexperimental questionnaire 36-38 weeks after baseline Evaluation of the study
- Secondary Outcome Measures
Name Time Method Actigraphy measurement Baseline Device that the children are wearing at their wrists
Sleep cartoon for children Baseline and 36-38 weeks after baseline Cartoon sleep behavior
Video of a sleeping sequence Baseline The parents are taking a short video sequence of their sleeping child
Demographic data Baseline age, gender, ethnicity, perinatal data from previous study participation
Kiddie-Sads-Present and Lifetime Version (K-SADS PL) Baseline Screening mental Illness
Self efficacy dealing with social situations (WIRKSOZ) Baseline and 36-38 weeks after baseline Self-efficacy measurement for social situations in children
Group interviews Baseline and 36-38 weeks after baseline Group interviews with experts and families to get feedback about the study procedure and needs
Trial Locations
- Locations (1)
University Hospital Tuebingen
🇩🇪Tuebingen, Germany