Investigating the effectiveness of a universal mental health literacy program on mental well-being in Czech schools
| ISRCTN | ISRCTN29904832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29904832 |
| ClinicalTrials.gov number | Nil Known |
| Secondary identifying numbers | 115/21 |
- Submission date
- 25/08/2022
- Registration date
- 26/08/2022
- Last edited
- 26/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
There are no studies to evaluate the benefits of mental health literacy in pre-adolescence when individuals are at increased risk for the onset of mental health problems in the context of Central and Eastern Europe. This study aims to evaluate the effectiveness of a mental health literacy intervention (On My Mind) delivered by trained teachers to students between the ages of 11 and 13 years in Czechia. Four areas of evaluation will be conducted, including: teacher competencies and effectiveness of teacher training course; assessment of implementation process and fidelity; the effect of the intervention on student outcomes, and the cost-effectiveness of the intervention.
Who can participate?
Schools from Plzen or Karlovy Vary in Czechia will be selected at random to participate. These schools include publicly funded schools (municipality or region) where the average 6th-grade classroom size is less than 5 and the primary language of instruction is Czech.
What does the study involve?
This study involves teachers' participation in 24-hour training, ongoing online reflections and supervision, and the implementation of 20 lesson plans within the subject of health education, which students will receive either in grade 6 (2021-2022) or grade 7 (2022-2023).
What are the possible benefits and risks of participating?
There are no large anticipated risks associated with participating in this study, but the themes of mental health, relationship skills, communication, and emotions can lead to confronting or uncomfortable discussions. All students will have a choice to actively participate in activities or discussions, and the student’s teacher has been trained in the curriculum and how to facilitate healthy and safe learning on the topic of mental health, and has access to supervision and resources for professionals in the field of mental health should any student reach out for help. Participating in the program can improve mental health literacy and social and emotional skills, and promote mental well-being and access to help if necessary.
Where is the study run from?
National Institute of Mental Health (Czechia)
When is the study starting and how long is it expected to run for?
January 2020 to October 2023
Who is funding the study?
EEA Grants/Norway Grants (Belgium)
Who is the main contact?
Anna Kagstrom, anna.kagstrom@nudz.cz
Contact information
Principal Investigator
4416 Hazelwood Avenue
Sacramento
95821
United States of America
 ORCID ID |
0000-0002-1455-1300 |
|---|---|
| Phone | +1 (0)46707349603 |
| anna.kagstrom@nudz.cz |
Study information
| Study design | Two-year long mixed methods three-arm multi-cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A mixed methods three-arm multi-cluster randomised controlled trial to investigate the effectiveness of a universal mental health literacy curriculum on teachers' and students' mental health and well-being in Czechia |
| Study acronym | CRCT-MHL-Cz |
| Study objectives | A structured mental health literacy curriculum will result in better well-being outcomes than generic treatment as usual (TAU) (health education section of the educational framework in Czechia), in terms of: H1: intervention effect on student outcomes of Universal Mental Health literacy for Adolescents, the Strengths and Difficulties Questionnaire (SDQ; Goodman, 2006), and the World Health Organization - Five Well-Being Index (WHO-5) H2: the intervention will be cost-effective in comparison to TAU |
| Ethics approval(s) | Approved 16/06/2021, Ethics Committee of the National Institute of Mental Health (NIMH, Topolová 748, 250 67 Klecany, Czechia; +420 (0)283 088 312; Martin.Bares@nudz.cz), ref: 115/21 |
| Health condition(s) or problem(s) studied | Mental health and well-being |
| Intervention | The intervention is delivered at the classroom level. The selection of the schools was conducted in collaboration with the Czech School Inspection (CSI), who randomly selected eligible schools, then cohorts of students to be followed over the course of 2 years (2021-2023). Schools were randomly selected from the national registry of schools, including 75 from each region (Plzen and Karlovo Vary). Selected schools were then randomly assigned to one of the three arms of the randomized controlled trial (RCT): 1) Intervention Arm, 2) Delayed Intervention Arm, or 3) Control Arm. Following randomization at the school level, the number of 6th-grade classrooms in each school was identified based on the national registry and one classroom within each school was selected at random and the classroom teacher was invited to take part in the study. The two intervention arms (1 delayed intervention) receive the mental health literacy intervention ‘On My Mind’ each over the course of 1 school year within the subject 'health education'. Arm A consists of the intervention group receiving On My Mind curriculum within health education in grade 6; Arm B consists of the intervention group receiving the On My Mind curriculum in grade 7; and Arm C is an active control group, receiving normal school provision within the subject ‘health education.’ On My Mind (Czech name: Všech Pět Pohromadě) is a universal program for schools, consisting of a curriculum and a teacher training course and an implementation manual. The curriculum consists of 20 lesson plans based on mental health literacy and social-emotional learning and is designed to be delivered over the course of a school year by trained teachers. The curriculum is designed to meet the developmental needs of 11-13 years old students and is delivered in the form of experiential, educational activities and discussions, with the teacher as a guide and role model for students. On My Mind teaches five main themes: mental health, emotional literacy, relationships, communication, and mental health first aid. The curriculum is intended to be delivered over the course of a school year with a consistent teacher and class, averaging one lesson plan per week, as the knowledge and skills students learn are built upon in subsequent lessons. Teacher training and manual: All On My Mind teachers are provided with comprehensive training and a corresponding manual with necessary theoretical and practical information about delivering the curriculum. The training and manual aim to support successful implementation of the curriculum, including foundational knowledge, skills, and attitudes related to mental health literacy and social and emotional learning, and to provide hands-on practice delivering lesson plan components. The training is delivered over 3 days with 8 hours of content each day totalling 24 hours of training. Training is accredited by the Ministry of Education, Youth and Sports. Teachers are trained by professionals from the field of mental health and well-being covering topics such as mental health and mental health problems, the key role of teachers in the program, principles and theory of mental health literacy and social and emotional learning, self-care tools for the teachers, pedagogical skills important for delivering the curriculum, and theoretical and developmental underpinnings of the themes and activities within the curriculum. |
| Intervention type | Behavioural |
| Primary outcome measure | Students across all groups will participate in four waves of data collection (Fall 2021; Summer 2022; Fall 2022; Summer 2023) on the outcomes: 1. Mental health literacy measured using the Universal Mental Health Literacy Scale for Adolescents (UMHL-A) 2. Behaviors measured using a brief behavioral screening questionnaire, the Strengths and Difficulties Questionnaire (SDQ) |
| Secondary outcome measures | Students across all groups will participate in four waves of data collection (Fall 2021; Summer 2022; Fall 2022; Summer 2023) on the outcomes: 1. Depressive symptoms assessed using the nine-item Patient Health Questionnaire (PHQ-9) 2. Symptoms of anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7) 3. Well-being assessed using the World Health Organization - Five Well-Being Index (WHO-5) |
| Overall study start date | 01/01/2020 |
| Completion date | 01/10/2023 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | A power analysis was conducted to determine appropriate sample size using G*power software (Faul, 2007, Faul, 2009). Using independent t-test. Parameters: Effect size d 0,2, alfa 0,05, Power 0,8. Allocation ratio 1. Estimated sample size 788. 394 per arm. Arm 1: On My Mind Intervention in grade 6 (n = 21) ; Arm 2: On My Mind Delayed Intervention in grade 7 (n = 21); Arm 3: Teaching as Usual of Health Education (n = 20) |
| Total final enrolment | 1043 |
| Key inclusion criteria | School-level criteria for inclusion: 1. Schools from Plzen or Karlovy Vary 2. Publicly funded schools (municipality or region) Classroom-level criteria: 1. The primary language of instruction is Czech |
| Key exclusion criteria | Since the intervention was delivered within the Czech school educational framework (RVP) for health education as a curriculum, the only stipulation for exclusion was not gaining informed consent from both the student and a parent/guardian. At the cluster level, exclusion criteria include: 2. No special or practical school 3. The average 6th-grade classroom size <5 4. RVP framework does not include health education in both the 6th and 7th grade |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 01/08/2021 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Klecany
250 67
Czech Republic
Sponsor information
Research organisation
Topolová 748
Klecany
250 67
Czech Republic
| Phone | +420 (0)283 088 111 |
|---|---|
| podatelna@nudz.cz | |
| Website | https://www.nudz.cz/ |
"ROR" |
https://ror.org/05xj56w78 |
Funders
Funder type
Other
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- EEA and Norway Grants, European Economic Area Grants
- Location
- Belgium
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results of the trial will be communicated by scientific articles in open access journals, letters for participants and non-participants of Czech schools, reports of findings and recommendations for scaling to collaborating institutes (Ministry of Education, Youth and Sports [MSMT], Czech School Inspection [CSI], National Institute of Education [NIE]) and articles for professional magazines intended for educators. |
| IPD sharing plan | Other than the authors no other entities have contractual agreements with regard to access to the final dataset. The datasets generated and/or analysed during the current study are not publicly available due to the ongoing research and the sensitive nature of the data. |
Editorial Notes
26/08/2022: Trial's existence confirmed by the Ethics Committee of the National Institute of Mental Health (NIMH).
