We used a CONSORT statement to describe the study – see
CONSORT flow diagram illustrating participant allocation and progress through the trial.
This study uses a stratified random sampling method that focuses exclusively on male participants aged 14–20 years. First, a school district is randomly selected from among the available districts. Within the selected district, schools are stratified and then randomly assigned to intervention and control groups. Three schools are assigned to the control group and three schools to the intervention group. A total of 102 male students will be randomly selected from all three schools in each group. The number of participants selected from each school will be proportional to the student population of that school, ensuring fair representation.
Male students were selected for this study due to specific cultural, religious, and logistical constraints. In the study setting, adolescent male students are the primary population with regular and independent access to mobile phones, a key requirement for participation in this digital communication-based intervention. Additionally, the male researcher’s access to female students’ mobile phone numbers is restricted by cultural norms and policies imposed by the Ministry of Education and Culture. These factors make the inclusion of female participants impractical within the framework of this study and necessitate a focus on male students to ensure the feasibility and integrity of the research design.
The main goal of this study is to determine the effect of education on the average score of mental health literacy in two intervention and control groups, which will be analyzed as the difference between the two averages. Since the minimum and maximum score of mental health literacy is between 29 and 130, therefore, the standard deviation of 25.25 points was considered and the number of samples in each group was determined in such a way that with 95% confidence and 80% test power, if the difference between the two averages A score greater than 12 is statistically significant. From the following formulas, the number of participants in each group was stated (
Sample size formula.
Therefore, for each of the intervention and control groups, 102 students will be randomly selected from among the second-high school students of Ramhormoz city (including 30% chance of dropping out). We try to select the number of people in each grade equally.
Ethical approval for the study was granted by the Ethics Committee of Tehran University of Medical Sciences (Approval date: 27/05/2023, Reference: IR.TUMS.SPH.REC.1402.075). This study aimed to assess the impact of a social media-based educational intervention on mental health literacy. Both participants and their parents were informed that participation was entirely voluntary, their data would remain confidential, and findings would only be presented in aggregate form for research purposes.
Detailed information about the study objectives, expected procedures, potential risks and benefits, confidentiality measures, and the voluntary nature of participation was provided to both participants and their parents or guardians.
Both participants and their parents were informed that they could withdraw from the study at any time without any penalties or negative consequences.
This dual-step consent and assent process was designed to uphold ethical standards and ensure that both parents and adolescents made fully informed, independent decisions.
To ensure participant privacy and confidentiality, all collected data will be anonymized and securely stored.
As a token of appreciation for their time and participation, participants will receive compensation in the form of a 10 GB internet package for 1 month.
Study results will be shared with the scientific community through publications and presentations, contributing to the broader understanding of mental health literacy interventions.
To be eligible for this study, male students enrolled in public high schools in Ramhormoz city must meet the following criteria:
Have access to a smartphone with an internet connection.
Demonstrate an understanding of both written and spoken Persian language.
Express willingness to participate in the research and provide informed consent.
Not having any known mental disorders or depressive symptoms.
Participants will be excluded from the analysis if they:
Withdraw their consent or express unwillingness to continue the research at any stage.
Migrate to another city or school during the study period.
Our planned intervention will utilize the Iranian social media platforms, Rubika and Eitaa, to disseminate the educational content of The Guide. The first author, acting as the primary facilitator, will conduct the program, which will be delivered through both synchronous and asynchronous formats. This blended approach allows for flexibility in learning while maintaining key engagement opportunities.
The first author will lead the educational program, organizing briefing sessions to ensure participants are well-informed about the program’s objectives, procedures, and expectations. These sessions will be conducted synchronously, allowing real-time interaction for better understanding and coordination.
The program will be structured around The Guide, with a thematic framework (outlined in
Thematic framework of mental health literacy and methods of deepening and feedback.
| The subject of intervention | Deepening and feedback | |
|---|---|---|
| 1 | Introduction: |
Question and Answer |
| 2 | The stigma |
Educational video Questions and Answers Stories |
| 3 | Information about specific mental illnesses |
Educational video Questions and Answers |
| 4 | Mental disorders of cognition and perception: psychotic disorders: |
Educational video Questions and Answers |
| 5 | Mental disorders of emotion and feeling: Mood disorders: |
Educational video Questions and Answers Stories |
| 6 | Mental disorder in signaling: |
Educational video Questions and Answers |
| 7 | Other mental disorders with hyperarousal symptoms: |
Educational video Questions and Answers |
| 8 | Psychosomatic disorder: eating disorders |
Educational video Questions and Answers |
| 9 | Behavioral disorders: |
Educational video Questions and Answers |
| 10 | Behaviors related to mental disorders: |
Educational video Questions and Answers Stories |
| 11 | Experiences of mental illness and the importance of family communication |
Question and Answer |
| 12 | Seek help and find support |
Question and Answer |
| 13 | What if (future scenarios in case of certain symptoms) |
Question and Answer |
| 14 | The importance of positive mental health |
Educational video Questions and Answers |
| 15 | List of community mental health resources |
Question and Answer |
The intervention will span 1 month, consisting of 15 sessions. Each session will last approximately 30 min to 1 h, with 3–4 sessions delivered per week to ensure timely completion. The content will be regularly updated on Rubika and Eitaa, allowing participants to access both synchronous and asynchronous materials.
Participants will be encouraged to actively engage through ongoing support, educational videos, and interactive Q&A sessions. Although the program is structured, participants will not have the flexibility to choose specific sessions based on preference, as all sessions are integral to the overall intervention. These strategies aim to maintain engagement throughout the study, with particular focus on improving retention, especially in the control group.
The educational content that the control participants receive at the end of the study will be provided in-person as a guide book rather than the online platform session content.
Please refer to
In this randomized trial study, the statistical population consists of secondary school students from schools in Ramhormoz city. After coordinating with the schools and obtaining the phone numbers of the students, the link of the questionnaire that was created through Porsline website will be shared with them. The students will be asked to complete the study tool before, 3, and 6 months after the intervention.
This questionnaire was developed and validated by O’Connor in 2015. This scale has 35 items and 6 dimensions to measure the level of MHL. The Persian version of this questionnaire has 29 items that have been psychometrically evaluated by People’s ability to diagnose mental disorders: This feature consists of eight items (for example: Do you think personality disorder is considered other than mental illness). This feature is measured using a 4-point Likert scale (very unlikely, unlikely, likely, very likely) is measured with a score range of 8–32. Attitudes that promote appropriate help-seeking cognition or behavior: This trait includes 10 items (e.g.: If I have a mental disorder, I do not like to tell anyone). This trait is assessed using a 5-point Likert scale [(strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) or (definitely willing, probably willing, neither willing nor unwilling, probably not willing, definitely not willing)] will be measured. Score range from 10 to 50. Awareness of self-healing: This feature includes two items (for example: if a person has a lot of difficulty managing his emotions, such as being anxious or depressed, how much do you think improving the quality of sleep would be useful for him?). This feature is measured using a 4-point Likert scale (not very useful, not useful, useful, very useful) with a score range of 2–8. Awareness of available professional help: This feature includes three items (e.g.: In your opinion, it is likely that cognitive behavioral therapy based on challenging negative thoughts and increasing beneficial behaviors). This feature is measured using a 4-point Likert scale (very unlikely, unlikely, likely, very likely) with a score range of 3–12. Awareness of where to look for information: This feature includes four items (e.g., I am sure that I can use the computer and telephone to look for information about mental disorders). This trait is measured using a 5-point Likert scale (Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree) with a score range of 4–20. Awareness of risk factors and causes: this characteristic consists of two items (for example: in general, to what extent do you think men in Iran may experience anxiety disorders more than women). This feature is measured using a 4-point Likert scale (very unlikely, unlikely, likely, very likely) with a score range of 2–8.
A high score for each attribute indicates a higher literacy rate for each attribute. Also, the total score of MHLS is obtained from the sum of the scores of all features. The lowest score is 29 and the highest is 130. Higher scores indicate more favorable MHL status. Based on the reliability results, MacDonald’s omega coefficient and Cronbach’s alpha coefficient for all MHLS features were 0.797 and 0.789, respectively.
ATSPPH-SF is a 10-item scale used to assess ATSPPH on a 4-point Likert scale, ranging from 0 to 3. The total scores range from 0 to 30, where a higher total score indicates a more positive ATSPPH and is associated with lower levels of stigma against mental illness. This scale included two dimensions: (1) openness to seeking professional help for emotional problems (items 1, 3, 5, 6, 7) with item scores from zero (disagree) to three (agree) (2) value and need in seeking help professional (items 2, 4, 8, 9, 10) with reverse scoring of items (zero = agree and three = disagree).
The statistical analysis of this study will be based on the intention-to-treat (ITT) principle, which includes all randomized participants regardless of their adherence to the intervention or their status at the end of the trial. The ITT analysis will preserve the balance of baseline characteristics achieved by randomization and reduce the risk of bias due to selective reporting or loss to follow-up (
Researchers anticipate several potential confounds that may influence the outcomes, such as: Pre-existing Mental Health Conditions: Variability in participants’ baseline mental health status may affect their response to the intervention. Socioeconomic Factors: Differences in socioeconomic status might influence participants’ access to mental health resources, potentially impacting outcomes.
The primary outcome of this study is the change in mental health literacy score (MHLS) from baseline to post-intervention and follow-up. The secondary outcome is the change in attitude towards seeking professional psychological help score from baseline to post-intervention and follow-up. Both outcomes will be measured using validated scales.
Demographic and baseline characteristics of the participants will be summarized using descriptive statistics, including mean, standard deviation, median, interquartile range, frequency, and percentage, as appropriate. The normality of the outcome variables will be assessed using graphical methods (histograms and Q-Q plots) and numerical tests (Shapiro–Wilk test). If the outcome variables are normally distributed, parametric tests will be employed; otherwise, non-parametric tests will be utilized.
Between-group differences in outcome variables at post-intervention and follow-up will be analyzed using analysis of covariance (ANCOVA), adjusting for baseline values and other potential confounders. Within-group changes in outcome variables from baseline to post-intervention and follow-up will be analyzed using paired t-tests or Wilcoxon signed-rank tests, depending on the normality assumption. Effect sizes and 95% confidence intervals will be reported for all comparisons.
We will employ techniques such as multilevel modeling (also known as hierarchical linear modeling) or generalized estimating equations (GEE) to model dependencies among observations within the same cluster. The level of significance for all statistical tests will be set at 0.05 (two-sided). All analyses will be conducted using SPSS software version 26.0.