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.
* 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
90
All families get the same diagnostics and receive individual treatment recommendations.
University Hospital Tuebingen
Tübingen, Germany
RECRUITINGBayley Scales of Infant and Toddler Development
IQ testing
Time frame: Baseline
Wechsler Intelligence Scale for Children (WISC-V)
IQ testing
Time frame: Baseline
Children's Sleep Habit Questionnaire (CSHQ-DE 4-10)
Screening of sleeping behaviour
Time frame: Baseline and 36-38 weeks after baseline
Sleep Self Report (SSR)
Screening of sleeping behaviour
Time frame: Baseline and 36-38 weeks after baseline
Somatics
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)
Time frame: Baseline and 36-38 weeks after baseline
Child Behavior Checklist (CBCL)
Screening for mental illness
Time frame: Baseline and 36-38 weeks after baseline
Youth Self Report (YSR)
Screening for mental illness
Time frame: Baseline and 36-38 weeks after baseline
Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB)
Screening for mental illness
Time frame: Baseline and 36-38 weeks after baseline
KIDSCREEN-27 (The KIDSCREEN)
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Health related quality of life
Time frame: Baseline and 36-38 weeks after baseline
Parent's Stress Inventory (EBI)
Load as parents and relationship to the child
Time frame: Baseline and 36-38 weeks after baseline
App-questions
Questions reflecting the questionnaires
Time frame: Baseline and 36-38 weeks after baseline
Postexperimental questionnaire
Evaluation of the study
Time frame: 36-38 weeks after baseline
Demographic data
age, gender, ethnicity, perinatal data from previous study participation
Time frame: Baseline
Actigraphy measurement
Device that the children are wearing at their wrists
Time frame: Baseline
Video of a sleeping sequence
The parents are taking a short video sequence of their sleeping child
Time frame: Baseline
Sleep cartoon for children
Cartoon sleep behavior
Time frame: Baseline and 36-38 weeks after baseline
Kiddie-Sads-Present and Lifetime Version (K-SADS PL)
Screening mental Illness
Time frame: Baseline
Self efficacy dealing with social situations (WIRKSOZ)
Self-efficacy measurement for social situations in children
Time frame: Baseline and 36-38 weeks after baseline
Group interviews
Group interviews with experts and families to get feedback about the study procedure and needs
Time frame: Baseline and 36-38 weeks after baseline