University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Location status: Recruiting
NCT Number: NCT06939192
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.
Interested in participating?
Request Info28 week–34 week
All sexes
Interventional
Not applicable
Tübingen, Baden-Wurttemberg, 72076, Germany
Location status: Recruiting
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 after estimated date of birth, and again after 2 months, as well as through focus groups with study participants.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Combination of app-based information and diagnostic screening for parents of premature babies.
No intervention. Treatment in the form of usual aftercare service is possible.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline (before treatment, T0).
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), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
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).
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).
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).
The partnership questionnaire measures the quality of the partnership with only 9 items in 3 subcategories (argumentative behavior, tenderness, communication), answered on a Likert scale.
Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
The PBQ is an instrument for assessing the quality of the postpartum relationship between mother and child. The questionnaire comprises 25 items and is answered on a Likert scale from 1 to 6.
Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1) and month 7 (follow-up, T2).
The questionnaire comprises a total of 29 items on the well-being and quality of life of the parent, covering a period of one week, answered on a five-point Likert scale from 0 (never) to 5 (always).
Time frame: At month 4 (post-teatment, T1) and month 7 (follow-up, T2).
The questionnaire is a developmental screening tool that measures developmental progress in children aged 1 month to 5 ½ years. It comprises a total of 30 questions, 6 for each developmental area on child communication, fine and gross motor skills, problem solving and social behavior.
Time frame: At baseline (before treatment, T0), after month 7 (follow-up, T1).
Conducting several focus groups with parents and professionals on the needs of post-inpatient care for parents with a premature baby. Survey of needs and feedback from the app group.
Time frame: Every 14 days over a period of 4 months (baseline, T0 - post-treatment, T1).
Questions about the child's and parents' state of health, well-being and perception of stress
Time frame: At month 4 (post-teatment, T1) and month 7 (follow-up, T2).
The translated questionnaire for measuring the use of healthcare services was developed based on the Health Care Utilization Questionnaire. Due to the young age of the children, some items were replaced. The questionnaire is intended to assess the families' respective use and utilization of medical and non-medical health care services.
Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
10 items on dealing with difficult situations and one's own perceived self-efficacy, answered on a scale from 1 (not true) to 4 (true).
Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
Assessment of height in cm assessed by a neonatologist.
Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
Assessment of weight in g by neonatgologist
Time frame: At baseline (before treatment, T0), at month 4 (post-teatment, T1).
Assessment of partents' reports of illnesses of the child. Open answer format, no scale.
Contact information is provided by the study sponsor or research team.
Annette Conzelmann, Prof. Dr.
CONTACT
00497071/29-87513
Annette Conzelmann, Prof.Dr.
CONTACT
00497071/29-87513
University Hospital Tuebingen
Other
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
Acronym: NeoUp2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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