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DepressionNCT06668688

Evaluation of the Naturalistic User Experience of the Website "ich Bin Alles @Schule" (i Am Everything @school)

An observational study of Depression and Depressive Disorder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to investigate the naturalistic user experience and acceptance of the German website "ich bin alles @Schule". This website for educational professionals offers information on depression and mental health of pupils. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
"ich bin alles @Schule" (i am everything @school; www.schule.ich-bin-alles.de)
Type of treatment
Medical device
How many people
100 participants
Where
1 siteGermany
Study dates
5 Jul 2024to Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: users of the website "ich bin alles @Schule" (i am everything @school; www.schule.ich-bin-alles.de)

Who may be able to join

  • 40 seconds Website-use

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Lisa Feldmann, Dr. contact

+4989440056920

Lisa.Feldmann@med.uni-muenchen.de

Ann-Kathrin Saffenreuther contact

+4989440056931

Annkathrin.Saffenreuther@med.uni-muenchen.de

Germany1 site, 1 recruiting

  • LMU University Hospital (recruitment is conducted online)

    Munich

    Lisa Feldmann, Dr., +4989440056920, Lisa.Feldmann@med.uni-muenchen.de

    Ann-Kathrin Saffenreuther, +4989440056931, Annkathrin.Saffenreuther@med.uni-muenchen.de

    Recruiting

Other trials in Germany

About this study

Official title: Evaluation of the Naturalistic User Experience of the Website "ich Bin Alles @Schule" (i Am Everything @school) - an Information Platform for Educational Professionals on Depression and Mental Health in Childhood and Adolescence

The aim of this study is to investigate the naturalistic user experience and acceptance of the German website "ich bin alles @Schule". This website for educational professionals offers information on depression and mental health of pupils. Another aim of this study is to determine whether the desired target groups of the website can be reached.

Read the detailed description

Depressive disorders are among the most common psychiatric disorders in childhood and adolescence and yet often are unnoticed and not treated for a long time. Depressive disorders often begin in adolescence and young adulthood. School stress, caused by bullying experiences at school or high performance expectations from parents and teachers, has been identified as an important factor in the development of depressive disorders in students. School, as a central area of life for children and young people, is an important place for promoting pupils' mental health. The rising prevalence of depressive disorders among adolescence in recent years and the delayed start of interventions show a clear need for action in the everyday lives of adolescents. The Department of Child and Adolescent Psychiatry of the Hospital of the LMU Munich and the Beisheim Foundation launched the innovative digital information portal "Ich bin alles @Schule" (i am everything @school; www.schule.ich-bin-alles.de) in November 2023. "ich bin alles @Schule" is a German information platform that was developed for educational professionals and aims to provide low-threshold information about depression and mental health in the school context.

Due to the high relevance of comprehensively evaluating web-based information services on mental health and mental illness, the aim of this study is to use established methods to learn more about the visitors of "ich bin alles @Schule" and their user experience.

The aim of the study is a scientific evaluation of the naturalistic user experience of "Ich bin alles @Schule" users. For this purpose, an online questionnaire and the website analysis tool "Matomo" is applied. The study is intended to provide clues as to whether the "ich bin alles @Schule" information platform is a useful and trustworthy source of information for the target group. The information obtained is of central importance for potential adaptations and optimizations of the website. Another aim of this study is to determine whether we can actually reach the desired target group with our website. The results of the data collection also provide an important basis for future approaches aimed at school professionals about mental health issues and mental illness in a way that is appropriate for the target group.

Being tested
"ich bin alles @Schule" (i am everything @school; www.schule.ich-bin-alles.de)
Keywords
depression, prevention, web-based, adolescents, mental health, school, user experience, acceptance, teachers
Medical subject headings
Depression, Depressive Disorder, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "ich bin alles @Schule" (i am everything @school; www.schule.ich-bin-alles.de)Device

    The web-based information platform for educational professionals "ich bin alles @Schule" (i am everything @school; www.schule.ich-bin-alles.de) on depression and mental health in childhood and adolescence was developed by the Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy at the LMU Munich Hospital together with the Prof. Otto Beisheim Foundation. The website is intended to provide low-threshold information about depression and mental health in the school context.

Study groups in NCT06668688
Study groupRoleWhat they receive
24-0395-KBNaturalistic User Experience "ich bin alles @Schule"
Receives: Device: "ich bin alles @Schule" (i am everything @school; www.schule.ich-bin-alles.de)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The characteristics of the people who are interested in "ich bin alles @Schule" (i.e. the users)

    Assessed via self-designed questionnaire

    Measured: 40 seconds after Website-use

  2. Perception of the users of website content

    Assessed via WEB-CLIC-S (Thielsch \& Hirschfeld, 2021)

    Measured: 40 seconds after Website-use

  3. Perceived Website Usability

    Assessed via Perceived Website Usability - German (PWU-G; Flavián et al., 2006; Thielsch, 2008)

    Measured: 40 seconds after Website-use

  4. Visual Aesthetics of Website

    Assessed via Visual Aesthetics of Website Inventory - Short (VisAWI-S; Moshagen \& Thielsch, 2013)

    Measured: 40 seconds after Website-use

  5. Intention to revisit the website

    Assessed via Scale assessing the intention to revisit the website (Moshagen \& Thielsch, 2010)

    Measured: 40 seconds after Website-use

  6. Overall impression

    Assessed via a single item by Thielsch (2008)

    Measured: 40 seconds after Website-use

Secondary outcomes (5)

  1. Specific data collected for "ich bin alles @Schule" with Matomo

    Title of the pages accessed (page title)

    Measured: two years (from website launch until anticipated stuy completion)

  2. Specific data collected for "ich bin alles @Schule" with Matomo

    Location of the users: Country, region, city, approximate latitude and longitude (geolocation)

    Measured: two years (from website launch until anticipated stuy completion)

  3. Specific data collected for "ich bin alles @Schule" with Matomo

    Number of the website users

    Measured: two years (from website launch until anticipated stuy completion)

  4. Specific data collected for "ich bin alles @Schule" with Matomo

    How users accessed the website (e.g. Google search or Social Media link)

    Measured: two years (from website launch until anticipated stuy completion)

  5. Specific data collected for "ich bin alles @Schule" with Matomo

    How much time (seconds) users spend on the website

    Measured: two years (from website launch until anticipated stuy completion)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study start5 Jul 2024
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06668688
Sponsor's protocol ID
24-0395-KB
Status last verified
Oct 2024
First submitted
24 Oct 2024
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Coppens E, Van Audenhove C, Iddi S, Arensman E, Gottlebe K, Koburger N, Coffey C, Gusmao R, Quintao S, Costa S, Szekely A, Hegerl U. Effectiveness of community facilitator training in improving knowledge, attitudes, and confidence in relation to depression and suicidal behavior: results of the OSPI-Europe intervention in four European countries. J Affect Disord. 2014 Aug;165:142-50. doi: 10.1016/j.jad.2014.04.052. Epub 2014 May 4.

    PubMed 24882192

  • Doll CM, Michel C, Rosen M, Osman N, Schimmelmann BG, Schultze-Lutter F. Predictors of help-seeking behaviour in people with mental health problems: a 3-year prospective community study. BMC Psychiatry. 2021 Sep 3;21(1):432. doi: 10.1186/s12888-021-03435-4.

    PubMed 34479537

  • Liao Y, Ameyaw MA, Liang C, Li W. Research on the Effect of Evidence-Based Intervention on Improving Students' Mental Health Literacy Led by Ordinary Teachers: A Meta-Analysis. Int J Environ Res Public Health. 2023 Jan 4;20(2):949. doi: 10.3390/ijerph20020949.

    PubMed 36673704

  • Thapar A, Eyre O, Patel V, Brent D. Depression in young people. Lancet. 2022 Aug 20;400(10352):617-631. doi: 10.1016/S0140-6736(22)01012-1. Epub 2022 Aug 5.

    PubMed 35940184

  • Thielsch, M. T., & Hirschfeld, G. (2021). Quick Assessment of Web Content Perceptions. International Journal of Human-Computer Interaction, 37(1), 68-80. https://doi.org/10.1080/10447318.2020.1805877

  • Thielsch, M. T. (unter Mitarbeit von Salaschek, M.) (2017). Toolbox zur kontinuierlichen Website-Evaluation und Qualitätssicherung (Version 2.1). Arbeitsbericht, Köln: Bundeszentrale für gesundheitliche Aufklärung (BZgA). http://dx.doi.org/10.17623/BZGA:224-2.1

  • Tong Y, Wang S, Cao L, Zhu D, Wang F, Xie F, Zhang X, Wang G, Su P. School dropouts related to mental disorders: A systematic review and meta-analysis. Asian J Psychiatr. 2023 Jul;85:103622. doi: 10.1016/j.ajp.2023.103622. Epub 2023 May 8. No abstract available.

    PubMed 37172421

  • Vieira MA, Gadelha AA, Moriyama TS, Bressan RA, Bordin IA. Evaluating the effectiveness of a training program that builds teachers' capability to identify and appropriately refer middle and high school students with mental health problems in Brazil: an exploratory study. BMC Public Health. 2014 Feb 28;14:210. doi: 10.1186/1471-2458-14-210.

    PubMed 24580750

  • Weist MD, Hoover SA, Daly BP, Short KH, Bruns EJ. Propelling the Global Advancement of School Mental Health. Clin Child Fam Psychol Rev. 2023 Dec;26(4):851-864. doi: 10.1007/s10567-023-00434-7. Epub 2023 May 29.

    PubMed 37247024

  • Flavián, C., Guinalíu, M., & Gurrea, R. (2006). The role played by perceived usability, satisfaction and consumer trust on website loyalty. Information & Management, 43(1), 1-14.

  • Moshagen, M. & Thielsch, M. T. (2010). Facets of visual aesthetics. International Journal of Human Computer Studies, 68 (10), 689-709. http://dx.doi.org/10.1016/j.ijhcs.2010.05.006

  • Moshagen, M. & Thielsch, M. T. (2013). A short version of the visual aesthetics of websites inventory. Behaviour & Information Technology, 32 (12), 1305-1311. http://dx.doi.org/10.1080/0144929X.2012.694910

  • Thielsch, M. T. (2008). Ästhetik von Websites. Wahrnehmung von Ästhetik und deren Beziehung zu Inhalt, Usability und Persönlichkeitsmerkmalen. Münster: MV Wissenschaft.

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Depressive Disorder, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lisa Feldmann, Dr. (+4989440056920, Lisa.Feldmann@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The characteristics of the people who are interested in "ich bin alles @Schule" (i.e. the users) (time frame: 40 seconds after Website-use). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06668688, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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