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

ConditionPreterm Birth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age28-34
SponsorUniversity Hospital Tuebingen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intervention Group (APP)

    Other intervention

    Combination of app-based information and diagnostic screening for parents of premature babies.

  • Treatment as usual-Group (TAU)

    Other intervention

    No intervention. Treatment in the form of usual aftercare service is possible.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Intervention Group (APP)Experimental treatment 1 intervention
Group B: Treatment as usual Group (TAU)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At month 4 (post-teatment, T1) and month 7 (follow-up, T2)
2

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.

Time frame
At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
3

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.

Time frame
At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

Secondary outcomes

1

Demographic data

The questionnaire includes, among other things, the age, gender, ethnicity and socio-demographic data of the test subjects.

Time frame
At baseline (before treatment, T0).
2

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.

Time frame
At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
3

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.

Time frame
At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
4

Edinburgh Postnatal Depression Scale (EPDS)

The EPDS measures depression in the last 7 days with 10 items.

Time frame
At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).

Other outcomes

Sponsors and contacts

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