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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic assessments and intervention | Other | All families get a diagnostics and intervention recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostics and intervention recommendations | Other | All families get the same diagnostics and receive individual treatment recommendations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bayley Scales of Infant and Toddler Development | IQ testing | Baseline |
| Wechsler Intelligence Scale for Children (WISC-V) | IQ testing | Baseline |
| Children's Sleep Habit Questionnaire (CSHQ-DE 4-10) | Screening of sleeping behaviour | Baseline and 36-38 weeks after baseline |
| Sleep Self Report (SSR) | Screening of sleeping behaviour | 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) | Baseline and 36-38 weeks after baseline |
| Child Behavior Checklist (CBCL) | Screening for mental illness | Baseline and 36-38 weeks after baseline |
| Youth Self Report (YSR) | Screening for mental illness | Baseline and 36-38 weeks after baseline |
| Diagnostic-system for mental illness for children and adolescents - III (DISYPS-III SCREEN FBB and SBB) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data | age, gender, ethnicity, perinatal data from previous study participation | Baseline |
| Actigraphy measurement | Device that the children are wearing at their wrists |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annette Conzelmann, Prof. Dr. | University Hospital Tuebingen | Principal Investigator |
| Axel Franz, Prof. Dr. | University Hospital Tuebingen | Principal Investigator |
| Mirja Quante, Dr. | University Hospital Tuebingen | Principal Investigator |
| Ándrea Bevot, Dr. | University Hospital Tuebingen | Principal Investigator |
| Tobias Renner, Prof. Dr. | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Tübingen | 72076 | Germany |
We share study material and statistical outputs.
Any time before and after completion of the study for 10 years.
Upon request.
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
Screening for mental illness
| Baseline and 36-38 weeks after baseline |
| KIDSCREEN-27 (The KIDSCREEN) | Health related quality of life | Baseline and 36-38 weeks after baseline |
| Parent's Stress Inventory (EBI) | Load as parents and relationship to the child | Baseline and 36-38 weeks after baseline |
| App-questions | Questions reflecting the questionnaires | Baseline and 36-38 weeks after baseline |
| Postexperimental questionnaire | Evaluation of the study | 36-38 weeks after baseline |
| Baseline |
| Video of a sleeping sequence | The parents are taking a short video sequence of their sleeping child | Baseline |
| Sleep cartoon for children | Cartoon sleep behavior | Baseline and 36-38 weeks after baseline |
| Kiddie-Sads-Present and Lifetime Version (K-SADS PL) | Screening mental Illness | Baseline |
| Self efficacy dealing with social situations (WIRKSOZ) | Self-efficacy measurement for social situations in children | Baseline and 36-38 weeks after baseline |
| Group interviews | Group interviews with experts and families to get feedback about the study procedure and needs | Baseline and 36-38 weeks after baseline |
| D000091642 | Urogenital Diseases |