E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families

Condition(s) studied

Investigational drug(s) / intervention(s)

Intervention Group (APP): Combination of app-based information and diagnostic screening for parents of premature babies.

Treatment as usual-Group (TAU): No intervention. Treatment in the form of usual aftercare service is possible.

Study summary

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

Primary outcome measure(s)

• Questionnaire on satisfaction, feasibility, needs (FB-NB) — At month 4 (post-teatment, T1) and month 7 (follow-up, T2)
  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) — At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
  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) — At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
  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.

Trial sites (1)

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