Clinical trial NCT06939192: E-health-supported Diagnostic and Intervention in Preterm Born Children and Their Families
Official title: E-health-supported Recording of Psychological and Somatic Problems, Risk and Resilience Factors of Premature Born Infants and Their Families and Individualized, Interdisciplinary Stepped-care Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Birth
Keywords: Preterm birth
E-health
Risk factors
Protective factors
Prevention
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 28
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: PREVENTION

Brief 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.

Detailed description: The project aims to conduct a longitudinal study of premature babies and their parents from the time of hospital discharge in order to identify predictive factors for their psychological and physical outcomes and to provide individualized interdisciplinary diagnostic and treatment. The project helps to identify risk and protective factors and also takes a closer look at the interplay between the mind and body. This care approach is supported by an app that records symptoms and needs and also allows contact with the study team. The app also provides psychoeducational materials. The study was developed in collaboration with affected families and experts from the aftercare team. The concept will be evaluated by comparing the treatment group with a TAU group and by conducting measurements after hospital discharge, after 4 months, and again after 7 months, as well as through focus groups with study participants.

Eligibility criteria: Inclusion Criteria:

* 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,
* sufficient knowledge of German,
* internet access

Exclusion Criteria:

* 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,
* no internet access,
* insufficient knowledge of German

Primary outcomes:
measure: Questionnaire on satisfaction, feasibility, needs (FB-NB)
timeFrame: At month 4 (post-teatment, T1) and month 7 (follow-up, T2)
measure: Parent Stress Inventory (EBI)
timeFrame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
measure: Crying, Feeding and Sleeping Questionnaire (SFS)
timeFrame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Secondary outcomes:
measure: Demographic data
timeFrame: At baseline (before treatment, T0).
measure: Brief Symptom Inventory (BSI)
timeFrame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
measure: Brief Infant Sleep Questionnaire (BISQ)
timeFrame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
measure: Couple Conflict Questionnaire (PFB-K)
timeFrame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
measure: Parent-Child Relationship Questionnaire (PBQ)
timeFrame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
measure: Ulm Quality of Life Inventory for Parents (ULQIE)
timeFrame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
measure: Ages & Stages Questionnaire®: Third Edition (ASQ-3)
timeFrame: At month 4 (post-teatment, T1) and month 7 (follow-up, T2).
measure: Focus groups
timeFrame: At baseline (before treatment, T0), after month 7 (follow-up, T1).
measure: App-questions
timeFrame: Every 14 days over a period of 4 months (baseline, T0 - post-treatment, T1).
measure: Questionnaire on health economics (HCU-Q)
timeFrame: At month 4 (post-teatment, T1) and month 7 (follow-up, T2).
measure: Self-efficacy questionnaire (SWE)
timeFrame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
state: Baden-Württemberg
Study officials:
affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
name: Annette Conzelmann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
name: Annika K Alt
role: STUDY_CHAIR
affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Tübingen
name: Tobias J Renner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Neonatology, University of Tübingen
name: Axel Franz, Prof. Dr.
role: STUDY_CHAIR
affiliation: Neonatology, University of Tübingen
name: Mirja Quante, Dr.
role: STUDY_CHAIR
affiliation: Neonatology, University of Tübingen
name: Michaela Minarski, Dr.
role: STUDY_CHAIR
affiliation: Clinical Psychology, FAU Erlangen
name: Johanna Löchner, Prof. Dr.
role: STUDY_CHAIR
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