About this trial
The app-based diagnostic and support approach with a focus on mental and somatic symptoms is intended to strengthen the resilience of premature born children and families and to identify risk and resilience factors.The overall objective of the study is to improve the post-inpatient care of families with premature born children. The procedure is evaluated by a two-arm design with an experimental group and a TAU group.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Premature babies born at the UKT,
Gestational age 28-34 weeks,
Mother: age ≥ 18 years,
agreement to participate in this study and signing of a consent form,
Disqualifiers
Premature babies < 28th or >34th week of pregnancy,
at least one of the children has serious diseases of the nervous system or obvious symptoms of a nervous disease,
at least one of the children has serious congenital diseases or suffers from malformations,
Mother: Lack of access to a smartphone/tablet,
Trial design
Parallel
Treatments tested in this trial
Intervention Group (APP)
Other interventionCombination of app-based information and diagnostic screening for parents of premature babies.
Treatment as usual-Group (TAU)
Other interventionNo intervention. Treatment in the form of usual aftercare service is possible.
Treatment groups
Trial outcomes
Primary outcomes
Questionnaire on satisfaction, feasibility, needs (FB-NB)
After completion of the main study phase, the self-constructed questionnaire assesses satisfaction with the study concept and evaluates the feasibility of the study approach. Patients are asked to indicate their satisfaction using a Likert scale and can also note down any additional or modification requests in free text fields.
Parent Stress Inventory (EBI)
The EBI measures the extent of parental stress and contains 48 items that are assigned to 12 subscales. Answering on a Likert scale.
Crying, Feeding and Sleeping Questionnaire (SFS)
The questionnaire on regulatory disorders in childhood uses 54 questions to assess early childhood regulatory disorders in relation to crying, eating or sleeping. The response format is generally a 4-point scale from not at all to very much.
Secondary outcomes
Demographic data
The questionnaire includes, among other things, the age, gender, ethnicity and socio-demographic data of the test subjects.
Brief Symptom Inventory (BSI)
The questionnaire is a short form of the SCL-90-R and measures the subjectively perceived impairment of a person through physical and psychological symptoms on nine scales (somatization, compulsiveness, insecurity in social contact, depressiveness, anxiety, aggressiveness / hostility, phobic anxiety, paranoid thinking, psychoticism) with 53 items, within a period of 7 days. Answering the questions on a Likert scale from 0 to 4.
Brief Infant Sleep Questionnaire (BISQ)
The BISQ is a short and simple questionnaire about the child's sleep duration, nocturnal awakenings and methods of falling asleep.
Edinburgh Postnatal Depression Scale (EPDS)
The EPDS measures depression in the last 7 days with 10 items.
Sponsors and contacts
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