tomoni.schools - An Online Training Program for Teachers to Prevent Mental Health in Children and Adolescents: Teachers` Evaluation (Study 1)

Organizational Data

DRKS-ID:
DRKS00032839
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-10-31
Last update in DRKS:
2023-12-14
Registration type:
Prospective

Acronym/abbreviation of the study

tomoni.schools - An Online Training Intervention for Teachers (Study 1)

URL of the study

https://www.med.uni-wuerzburg.de/dzpp/studien/tomonischools/

Brief summary in lay language

No Entry

Brief summary in scientific language

Background: More than half of all mental disorders begin already in childhood and adolescence (Jones, 2013; Kessler et al., 2005). Mental illness affects about 13-14% of adolescents worldwide (UNICEF, 2021). Anxiety disorders, depression, externalizing disorders (e.g. ADHD, conduct disorder) and emotional disorders are particularly frequent (Polanczyk et al., 2015). Mental disorders are associated with lower life quality, life satisfaction and educational status and an increased risk for other mental health problems as well as higher somatic symptom burden (Schlack et al., 2021). Moreover, COVID-19 pandemic raised the risk of mental health issues in children and adolescents (Holtmann et al., 2023). Teachers play a key role in preventing severe courses of illness or chronification of mental disorders in children and adolescents. As gatekeeper, they can recognize first signs of mental problems in their students, they can approach them and, if necessary, refer them to the adequate services. For this responsible task, teachers need sufficient ‘Mental Health Literacy' (MHL), which is defined as knowledge and beliefs, which enable the recognition, management and prevention of mental disorders (Jorm et al., 1997). The aim is to increase the teachers’ ability to act when dealing with psychologically distressed students pupils and to strengthen the teachers’ confidence in their own abilities (Whitley et al., 2013). However, this does not mean teachers shall diagnose or treat mental disorders. They can notice displays of mental problems, speak respectfully with affected students, know their professional boundaries in such cases and refer those seeking help to the appropriate professional health care system. tomoni.schools training program: tomoni mental health gGmbh developed this online training program for teachers aiming to prevent mental health in children and adolescents. During the program teachers learn to recognize possible signs of mental health issues and to reach out to the pupils concerned in a respectful manner. The training program consists of eight modules, 90 minutes each. After completing the basic module, teachers can participate in seven specialist modules. All modules are divided in a section providing knowledge and a section enhancing the ability to act. Newly acquired strategies will be directly put into practice and trained in role plays. The modules will be presented by so-called 1) experts of daily life (group 1), who had experienced mental illness themselves or 2) scientific experts (group 2), who acquired broad expert knowledge about mental disorders in the context of their professional training and/or workplace (e.g. students of psychology, psychologists, psychotherapists in training, licensed psychotherapists/child and adolescent psychotherapists, psychiatrists/child and adolescent psychiatrists). Study design and method: The goal of the study is to evaluate the program tomoni.schools for teachers. In a further study, which will be submitted with a separate study protocol at the DRKS (German register of clinical trials), we will evaluate the program for pupils. In this study teachers will be assigned randomly to one of four experimental groups. Group 1 will receive the training program from experts of daily life over a period of three months. Group 2 will receive the training program from scientific experts over a period of three months. Teachers in group 3 are in the active control group. They will be provided with reading material about the modules (and supplementary videos). Group 4 is the passive control group and does not undergo any intervention during the study. After the last follow-up survey, teachers of group 3 and 4 can participate in the modules of tomoni.schools. To evaluate the program, follow-up survey data will be collected from the teachers 3 months after they completed the final module (T1). In order to examine the long-term effect of the program, another follow-up survey will be collected 12 months after the teachers finished the training program (T2). Following the guidelines of GCP (good clinical practice), we differentiate between primary and secondary outcomes in our study. The primary outcome is the teachers’ self-estimated readiness for action. Secondary outcomes comprise knowledge about mental diseases, stigmatization of mental illness, confidence in one’s own ability to act and general mental health. To our knowledge, no validated survey pertaining to the given research questions has yet been developed. Therefore, the working group created the 'Mental Health Literacy and Prevention Survey' (mHELP), which will be validated in the baseline measurement (T0) based on Classical test theory. For more instruments used in the study, see ‘Outcomes’. Data will be collected online via REDCap (Research Electronic Data Capture). For statistical analyses, the current version of RStudio will be used (RStudio Team, 2020; http://www.rstudio.com/). Mixed models for continuous variables will be calculated with interactions between groups and time points at baseline (T0) and at follow-up (T2) to answer the research questions. Further analyses will include comparisons with time point at follow-up T1.

Health condition or problem studied

Free text:
Mental illness in children and adolescents, mental health in children and adolescents
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
Group 1: Experts of Daily Life For teachers participating in group 1 the tomoni.schools training program will be conducted by Experts of Daily Life, who had gone through mental illness themselves in the past and who are now at a stable functional level in everyday life after completing therapeutic treatment. Experts of Daily Life receive supervision by a licensed psychotherapist during their initial training and after conducting their first and third teacher training. Training modules and content: The tomoni.schools training program consists of eight online modules, 90 minutes each. Every module has a section providing knowledge and a section enabling practical experience by testing learned strategies in role plays. The topics of the modules are: - Basic module - Module on depression - Module on anxiety disorders - Module on self-injurious behavior - Module on suicidal tendencies - Module on eating disorders - Module on addiction and substance abuse disorders - Module on parent-teacher interviews
Arm 2:
Group 2: Scientific experts For teachers participating in group 2 the tomoni.schools training program will be conducted by scientific experts, who have acquired broad specialist knowledge about mental illness as part of of their professional education and/or workplace. Among the scientific experts are students of psychology, psychologists, psychotherapists in training, licensed psychotherapists/child and adolescent psychotherapists, resident physicians in psychiatry, psychiatrists/child and adolescent psychiatrists or specialists from related professions. Modules and contents of the training program are equivalent to those in group 1.
Arm 3:
Group 3: Active control group (KGa) Teachers participating in group 3 will receive a bibliointervention / an intervention in the form of reading material. This means that the training information will be made available in handouts and supplementary video material for each module. Participants of this group can take part in the training program after completing the follow-up survey.
Arm 4:
Group 4: Passive control group (KGp) Group 4 corresponds to a waiting list control group, in which the participating teachers will not receive an intervention during the course of the study. Comparable to KGa, they can take part in the training program after the follow-up survey.

Endpoints

Primary outcome:
The primary outcome consists of the teachers’ self-assessed readiness for action 12 months after completing the tomoni.schools training program: readiness to reach out to students showing signs of mental illness and to offer help, which will be measured using the 'readiness for action' subscale of the 'Mental Health Literacy and Prevention Survey' (mHELP), created by the working group. To compare changes in readiness for action, data will be collected at time point T0 (before participation in tomoni.schools), T1 and T2 (three and twelve months after completing tomoni.schools training program).
Secondary outcome:
Secondary outcomes and research instruments: - knowledge about mental diseases: Mental Health Knowledge Schedule – MAKS (Evans-Lacko et al., 2010), vignette + corresponding questions (Jorm et al., 2007), mHELP (subscale knowledge) - stigmatization: Questionnaire Mental Health Literacy – QLSM (factor 2: stigmatization; Almeida et al., 2017), mHELP (subscale stigmatization) -confidence in one’s own helping behaviour in dealing with students who have mental health problems: vignette + corresponding questions (Jorm et al., 2007), mHELP (subscale confidence in own capacity for action) - Mental health in general: ICD-10 Symptom-Rating – ISR (Tritt et al., 2008)

Study Design

Purpose:
Prevention
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Universitätsklinikum Würzburg, Klinik für Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie online

Recruitment period and number of participants

Planned study start date:
2023-11-15
Actual study start date:
2023-12-04
Planned study completion date:
2024-12-31
Actual Study Completion Date:
No Entry
Target Sample Size:
268
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
teachers at secondary schools

Exclusion Criteria

- No informed consent

Addresses

Primary Sponsor

Address:
Universitätsklinikum Würzburg, Zentrum für Psychische Gesundheit, Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie
Prof. Dr. Marcel Romanos
Margarete-Höppel-Platz 1
97080 Würzburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Universitätsklinikum Würzburg, Zentrum für Psychische Gesundheit, Kinder- und Jugendpsychiatrie, Psychosomatik, Psychotherapie
Sarah Franke
Margarete-Höppel-Platz 1
97080 Würzburg
Germany
Telephone:
+49 931 201 78600
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Address:
Universitätsklinikum Würzburg, Zentrum für Psychische Gesundheit, Kinder- und Jugendpsychiatrie, Psychosomatik, Psychotherapie
Sabrina Mittermeier
Margarete-Höppel-Platz 1
97080 Würzburg
Germany
Telephone:
+49 931 201 78600
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Principal Investigator

Address:
Universitätsklinikum Würzburg, Zentrum für Psychische Gesundheit, Kinder- und Jugendpsychiatrie, Psychosomatik, Psychotherapie
Dr. phil. Arne Bürger
Margarete-Höppel-Platz 1
97080 Würzburg
Germany
Telephone:
+49 931 201 78600
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Address:
tomoni mental health gGmbh
Schweizer Str. 13
60594 Frankfurt
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Ethikkommission der DGPs
Zur Weinstraße 10
35041 Marburg
Germany
Telephone:
+49 6421 93056
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2023-09-14
Ethics committee number:
BuergerArne2023-09-14WV
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-10-20

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
DRKS00032888 - Studie 2: Evaluation tomoni.schools auf Ebene der Schüler*innen

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry