Mental Health LiteracyNCT04597996
Web-based Mental Health Literacy Program
A study testing web based education for students in people with Mental Health Literacy, run by Dokuz Eylul University.
Trial summary
Mental health literacy is a concept that aims to improve the skills of individuals to overcome difficulties in providing the appropriate help they need in this area. It provides individuals with motivation in this area such as informing and taking responsibility in the field of mental health, directing their behavior… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Literacy
- What is being tested?
- web based education for students
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Feb 2023
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- between the ages of 12-18 (inclusive)
- volunteering to participate
- having the access to internet
- knowing how to use the internet
- without visual impairment
- without hearing impairment
- without perceptual impairment
Who cannot join
- not volunteering to participate
- not having the access to internet
- not knowing how to use the internet
- with visual impairment
- with hearing impairment
- with perceptual impairment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Web-Based Mental Health Literacy Program on Students' Level of Knowledge, Help-Seeking and Stigmatization Attitudes
Mental health literacy is a concept that aims to improve the skills of individuals to overcome difficulties in providing the appropriate help they need in this area. It provides individuals with motivation in this area such as informing and taking responsibility in the field of mental health, directing their behavior, facilitating access to and obtaining information, understanding, evaluating, using, and maintaining information.
Objective: This project aims to examine the effect of web-based mental health literacy intervention carried out by school nurses on students' level of knowledge, help-seeking and stigmatization attitudes.
Read more
Method: Randomized Controlled Trial Research design (pre-test post-test control group design) will be used in the project. The data will be collected through the Mental Health Literacy Scale for Children and Adolescents (MHLS), Attitude Scale for Seeking Psychological Help-Short Form (ASPH-S), Self-Stigma in Seeking Psychological Help Scale (SSSPHS) and the sociodemographic Question Form.
The project will be carried out with the students of a secondary school and a high school in the district of Balçova, İzmir province. Sampling calculation Based on the analysis of variance in repeated measurements in 2 groups in the G Power program, Type1 Error 0.05 (alpha 5%) Type2 Error 0.20 (80% power), the sample size calculated in duplicate measurements with medium effect size is 43 participants for each group (Intervention-Control) calculated. Considering that there might be losses during data collection, it is planned to include 50 students for the intervention group and 50 students for the control group. Analysis of variance will be used in the evaluation of data, number, percentage, and descriptive statistics, and in repeated measures to evaluate the effect of the intervention The training modules to be prepared within the scope of the project will focus on the mental health literacy level of the child, attitudes to seek help and stigmatization. Among the teaching materials planned to be prepared for this purpose, there will be short animated course videos, video course contents, and audio presentations. In the study, where web-based education is planned, teaching materials will be delivered to students through the learning management system. Teaching materials and learning management systems will be designed in accordance with mobile technologies and access will be provided from smartphones, tablet computers, and similar mobile devices. During the teaching material development phase, firstly, educational content drafts (storyboards) will be created and presented to field experts, and their opinions on content, teaching approach, methods and techniques, and visual design principles will be taken. Pilot studies will be conducted to understand the educational content during the improvement phase of the developed teaching material designs. It is planned to finalize the training content in light of user feedback.
Read the detailed description
In this study, the investigators aim to examine the effect of mental health literacy Web-based education intervention on the knowledge level, help-seeking and stigmatization attitudes of students.
This study is a randomized controlled trial. The study population consists of students studying in two schools located in Izmir province in western Turkey. Fifty people were assigned to the intervention and control groups each and a total of 100 participants were planned to be included.
The study will be conducted between January-September 2022. Students between the ages of 12-18 who voluntarily agree to participate in the study will be included in this study. Another criterion is that all sampled groups be able to access and use the internet.
Those who have visual, perceptual, or auditory problems and cannot access or use the internet will not be included in the study.
Psychometric evaluation of scales:
Mental Health Literacy Scale for Children and Adolescents (MHLS): This scale, developed by Rozbruch and Friedberg (2018), consists of 5 items. The Cronbach alpha coefficient calculated for the internal consistency of the scale is .84. The scale is a three-point Likert-type scale consisting of two items multiple choice, one item open-ended, two items 8 sub-dimensions (Parents, Friends, Clergyman, Psychologist, Counselor, Psychiatrist, Family Doctor, Teacher) (not suitable - not sure - suitable) has the option to answer. The lowest value that can be taken from the scale varies between 0 and the highest value: 6. (question 1: 1 point, question 3: 2 points, question 4: 2 points, question 5: 1 point) Turkish adaptation of the scale was made by the researchers Attitude Scale for Seeking Psychological Help-Short Form (ASPH-S): This tool, which aims to measure attitudes towards getting psychological help (ASPH-S), is a revised and abbreviated version of ASPH, developed by Türküm (1997). As a result of the factor analysis performed for the construct validity of the ASPH-S scale, it was determined that it consists of a two-factor structure that includes positive (12 items) and negative (6 items) seeking psychological help, explaining 52.6% of the total variance. The Cronbach's alpha coefficient calculated for internal consistency of the scale consisting of 18 items is .90. Test-retest reliability for stability over time. It was found to be 77. The score that can be obtained from the scale is between 18 and 90, and the low score indicates that there is no need for help. The scale, which consists of 5 Likert-type categories, is scored as Fully Agree, Strongly Agree, Undecided, Somewhat Agree, and Never Disagree. (Fully Agree = 5, Strongly Agree = 4, Undecided = 3 Somewhat Agree = 2, Not at all = 1) 6 items of the scale are calculated by scoring in reverse. These items are: 2, 8, 12, 13, 16, 17.
Self-Stigma in Seeking Psychological Help Scale (SSSPHS): The scale developed by Vogel et al. (2006) consists of ten items. The scale is a 5-point Likert type one-dimensional scale. The scale was adapted to Turkish by Kapıkıranlar (2013). Cronbach alpha value is calculated for the internal consistency of the scale. Is 71. Confirmatory factor analysis of the one-dimensional scale was performed. The internal consistency of university students (17-33) was calculated as .91, and the test-retest reliability with an interval of two months was calculated as .72. Some items of the scale are scored reversely, and high scores indicate the high level of self-stigma in asking for help. Some items of the scale are scored inversely, and a high score indicates a high level of self-stigma in asking for help.
Ethics Committee approval was obtained from Dokuz Eylül University Health Sciences Institute. (2019 / 23-23) The permit of the institution will be obtained from the İzmir Provincial Directorate of the National Education Strategy Development Unit. Informed consent will be obtained from the parents on behalf of their children.
Dependent Variable: Adolescent Mental Health Literacy knowledge level, Attitudes towards Seeking Psychological Help, Self-Stigma in Seeking Psychological Help score averages
Independent Variable: Mental Health literacy education
- Conditions
- Mental Health Literacy
- Being tested
- web based education for students
- Keywords
- Web Based, Health Education, School Nurse, Mental Health Literacy, Adolescents, Students
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web based education for studentsOther
Web-based education will include modules on the following subjects;
- Mental health literacy knowledge level
- Improving help-seeking behavior
- Avoiding self-stigmatization in seeking psychological help
| Study group | Role | What they receive |
|---|---|---|
| Web Based Education | Experimental | A pre-test will be applied. Web-based education will be conducted. The post-test will be applied twice, the first one to be performed 4 weeks after Web-based education is completed and the second one 3 months after Web-based education is completed. Receives: Other: web based education for students |
| No Intervention Group | No intervention | The control group will not have any intervention during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Literacy Scale for Children and Adolescents (MHLS)
It is a three-point Likert-type scale consisting of two items multiple choice, one item open-ended, two items 8 sub-dimensions (Parents, Friends, Clergyman, Psychologist, Counselor, Psychiatrist, Family Doctor, Teacher) (not suitable - not sure - suitable) has the option to answer. The lowest value that can be taken from the scale varies between 0 and the highest value: 6. (question 1: 1 point, question 3: 2 points, question 4: 2 points, question 5: 1 point).
Measured: 3 MONTH
Attitude Scale for Seeking Psychological Help-Short Form (ASPH-S)
It consists of a two-factor structure that includes positive (12 items) and negative (6 items) seeking psychological help, explaining 52.6% of the total variance. The scale, which consists of 5 Likert-type categories, is scored as Fully Agree, Strongly Agree, Undecided, Somewhat Agree, and Never Disagree. (Fully Agree = 5, Strongly Agree = 4, Undecided = 3 Somewhat Agree = 2, Not at all = 1) 6 items of the scale are calculated by scoring in reverse. These items are: 2, 8, 12, 13, 16, 17.The score that can be obtained from the scale is between 18 and 90, and the low score indicates that there is no need for help.
Measured: 3 MONTH
Self-Stigma in Seeking Psychological Help Scale (SSSPHS)
The scale is a 5-point Likert type one-dimensional scale with 10 items. Some items of the scale are scored reversely, and high scores indicate the high level of self-stigma in asking for help. Some items of the scale are scored inversely, and a high score indicates a high level of self-stigma in asking for help.
Measured: 3 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Apr 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pre test post test model design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ozlem ozkan salkim, Dokuz Eylul University
- Investigators
- ozlem ozkan salkim, Principal investigator, Dokuz Eylul UniversitySeyda OZBICAKCI, Assoc. Prof, Study director, Dokuz Eylul UniversityYasemin KAHYAOĞLU ERDOĞMUŞ, PhD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597996
- Sponsor's protocol ID
- 2019/23-23
- Status last verified
- Apr 2022
- First submitted
- 16 Oct 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web-Based Mental Health Literacy Program on Students' Level of Knowledge, Help-Seeking and Stigmatization Attitudes
- ClinicalTrials.gov ID
- NCT04597996
- Acronym / sponsor ID
- 2019/23-23
- Conditions
- Mental Health Literacy
- Keywords
- Web Based, Health Education, School Nurse, Mental Health Literacy, Adolescents, Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mental health literacy is a concept that aims to improve the skills of individuals to overcome difficulties in providing the appropriate help they need in this area. It provides individuals with motivation in this area such as informing and taking responsibility in the field of mental health, directing their behavior, facilitating access to and obtaining information, understanding, evaluating, using, and maintaining information.
Objective: This project aims to examine the effect of web-based mental health literacy intervention carried out by school nurses on students' level of knowledge, help-seeking and stigmatization attitudes.
Method: Randomized Controlled Trial Research design (pre-test post-test control group design) will be used in the project. The data will be collected through the Mental Health Literacy Scale for Children and Adolescents (MHLS), Attitude Scale for Seeking Psychological Help-Short Form (ASPH-S), Self-Stigma in Seeking Psychological Help Scale (SSSPHS) and the sociodemographic Question Form.
The project will be carried out with the students of a secondary school and a high school in the district of Balçova, İzmir province. Sampling calculation Based on the analysis of variance in repeated measurements in 2 groups in the G Power program, Type1 Error 0.05 (alpha 5%) Type2 Error 0.20 (80% power), the sample size calculated in duplicate measurements with medium effect size is 43 participants for each group (Intervention-Control) calculated. Considering that there might be losses during data collection, it is planned to include 50 students for the intervention group and 50 students for the control group. Analysis of variance will be used in the evaluation of data, number, percentage, and descriptive statistics, and in repeated measures to evaluate the effect of the intervention The training modules to be prepared within the scope of the project will focus on the mental health literacy level of the child, attitudes to seek help and stigmatization. Among the teaching materials planned to be prepared for this purpose, there will be short animated course videos, video course contents, and audio presentations. In the study, where web-based education is planned, teaching materials will be delivered to students through the learning management system. Teaching materials and learning management systems will be designed in accordance with mobile technologies and access will be provided from smartphones, tablet computers, and similar mobile devices. During the teaching material development phase, firstly, educational content drafts (storyboards) will be created and presented to field experts, and their opinions on content, teaching approach, methods and techniques, and visual design principles will be taken. Pilot studies will be conducted to understand the educational content during the improvement phase of the developed teaching material designs. It is planned to finalize the training content in light of user feedback.
Detailed description
In this study, the investigators aim to examine the effect of mental health literacy Web-based education intervention on the knowledge level, help-seeking and stigmatization attitudes of students.
This study is a randomized controlled trial. The study population consists of students studying in two schools located in Izmir province in western Turkey. Fifty people were assigned to the intervention and control groups each and a total of 100 participants were planned to be included.
The study will be conducted between January-September 2022. Students between the ages of 12-18 who voluntarily agree to participate in the study will be included in this study. Another criterion is that all sampled groups be able to access and use the internet.
Those who have visual, perceptual, or auditory problems and cannot access or use the internet will not be included in the study.
Psychometric evaluation of scales:
Mental Health Literacy Scale for Children and Adolescents (MHLS): This scale, developed by Rozbruch and Friedberg (2018), consists of 5 items. The Cronbach alpha coefficient calculated for the internal consistency of the scale is .84. The scale is a three-point Likert-type scale consisting of two items multiple choice, one item open-ended, two items 8 sub-dimensions (Parents, Friends, Clergyman, Psychologist, Counselor, Psychiatrist, Family Doctor, Teacher) (not suitable - not sure - suitable) has the option to answer. The lowest value that can be taken from the scale varies between 0 and the highest value: 6. (question 1: 1 point, question 3: 2 points, question 4: 2 points, question 5: 1 point) Turkish adaptation of the scale was made by the researchers Attitude Scale for Seeking Psychological Help-Short Form (ASPH-S): This tool, which aims to measure attitudes towards getting psychological help (ASPH-S), is a revised and abbreviated version of ASPH, developed by Türküm (1997). As a result of the factor analysis performed for the construct validity of the ASPH-S scale, it was determined that it consists of a two-factor structure that includes positive (12 items) and negative (6 items) seeking psychological help, explaining 52.6% of the total variance. The Cronbach's alpha coefficient calculated for internal consistency of the scale consisting of 18 items is .90. Test-retest reliability for stability over time. It was found to be 77. The score that can be obtained from the scale is between 18 and 90, and the low score indicates that there is no need for help. The scale, which consists of 5 Likert-type categories, is scored as Fully Agree, Strongly Agree, Undecided, Somewhat Agree, and Never Disagree. (Fully Agree = 5, Strongly Agree = 4, Undecided = 3 Somewhat Agree = 2, Not at all = 1) 6 items of the scale are calculated by scoring in reverse. These items are: 2, 8, 12, 13, 16, 17.
Self-Stigma in Seeking Psychological Help Scale (SSSPHS): The scale developed by Vogel et al. (2006) consists of ten items. The scale is a 5-point Likert type one-dimensional scale. The scale was adapted to Turkish by Kapıkıranlar (2013). Cronbach alpha value is calculated for the internal consistency of the scale. Is 71. Confirmatory factor analysis of the one-dimensional scale was performed. The internal consistency of university students (17-33) was calculated as .91, and the test-retest reliability with an interval of two months was calculated as .72. Some items of the scale are scored reversely, and high scores indicate the high level of self-stigma in asking for help. Some items of the scale are scored inversely, and a high score indicates a high level of self-stigma in asking for help.
Ethics Committee approval was obtained from Dokuz Eylül University Health Sciences Institute. (2019 / 23-23) The permit of the institution will be obtained from the İzmir Provincial Directorate of the National Education Strategy Development Unit. Informed consent will be obtained from the parents on behalf of their children.
Dependent Variable: Adolescent Mental Health Literacy knowledge level, Attitudes towards Seeking Psychological Help, Self-Stigma in Seeking Psychological Help score averages
Independent Variable: Mental Health literacy education
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- pre test post test model design
| Arm | Type | Receives |
|---|---|---|
| Web Based Education | Experimental | Other: web based education for studentsA pre-test will be applied. Web-based education will be conducted. The post-test will be applied twice, the first one to be performed 4 weeks after Web-based education is completed and the second one 3 months after Web-based education is completed. |
| No Intervention Group | No intervention | –The control group will not have any intervention during the study. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- between the ages of 12-18 (inclusive)
- volunteering to participate
- having the access to internet
- knowing how to use the internet
- without visual impairment
Key exclusion criteria (6 listed)
- not volunteering to participate
- not having the access to internet
- not knowing how to use the internet
- with visual impairment
- with hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web based education for studentsWeb-based education will include modules on the following subjects; * Mental health literacy knowledge level * Improving help-seeking behavior * Avoiding self-stigmatization in seeking psychological help | Other | Web Based Education |
Primary outcome
Mental Health Literacy Scale for Children and Adolescents (MHLS)
Time frame: 3 MONTH
It is a three-point Likert-type scale consisting of two items multiple choice, one item open-ended, two items 8 sub-dimensions (Parents, Friends, Clergyman, Psychologist, Counselor, Psychiatrist, Family Doctor, Teacher) (not suitable - not sure - suitable) has the option to answer. The lowest value that can be taken from the scale varies between 0 and the highest value: 6. (question 1: 1 point, question 3: 2 points, question 4: 2 points, question 5: 1 point).
Attitude Scale for Seeking Psychological Help-Short Form (ASPH-S)
Time frame: 3 MONTH
It consists of a two-factor structure that includes positive (12 items) and negative (6 items) seeking psychological help, explaining 52.6% of the total variance. The scale, which consists of 5 Likert-type categories, is scored as Fully Agree, Strongly Agree, Undecided, Somewhat Agree, and Never Disagree. (Fully Agree = 5, Strongly Agree = 4, Undecided = 3 Somewhat Agree = 2, Not at all = 1) 6 items of the scale are calculated by scoring in reverse. These items are: 2, 8, 12, 13, 16, 17.The score that can be obtained from the scale is between 18 and 90, and the low score indicates that there is no need for help.
Self-Stigma in Seeking Psychological Help Scale (SSSPHS)
Time frame: 3 MONTH
The scale is a 5-point Likert type one-dimensional scale with 10 items. Some items of the scale are scored reversely, and high scores indicate the high level of self-stigma in asking for help. Some items of the scale are scored inversely, and a high score indicates a high level of self-stigma in asking for help.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Mental Health Literacy
Not yet recruiting
The Health Literacy for Healthier Mind Study
Health Literacy, Occupational Health
Active, not recruiting
Evaluation of Effectiveness of the LifeSkills Training - Lombardia - Primary Shool Program ( Val3P-LST )
Well Being, Drug Addiction
Not yet recruiting
Psychosocial Support Program for Public School Teachers
Mental Health Literacy, School Mental Health Training of Teachers
RecruitingObservational study
Addressing Pregnant Women's First Trimester Worries and Information Needs With mHealth Solutions
Pregnancy Trimester, First, Anxiety
Active, not recruitingObservational study
Health Surveillance at Constructor University Bremen (CUB)
Social Isolation or Loneliness, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ozlem ozkan salkim principal investigator
Dokuz Eylul University
Seyda OZBICAKCI, Assoc. Prof study director
Dokuz Eylul University
Yasemin KAHYAOĞLU ERDOĞMUŞ, PhD principal investigator
Dokuz Eylul University
Questions about this trial
What is this clinical trial studying?
A study testing web based education for students in people with Mental Health Literacy, run by Dokuz Eylul University.
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 7 inclusion and 6 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 ozlem ozkan salkim, PhD (+905336838597, ozlemozkansalkim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Literacy Scale for Children and Adolescents (MHLS) (time frame: 3 MONTH). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2022.