Outcomes

The following core outcomes will be used to assess the intervention. All outcome measures will be measured at the individual student level.

The primary outcome, Positive mental health literacy will be measured using a 10-item Mental Health-Promoting Knowledge (MHPK-10) scale. It is a valid and reliable one-dimensional instrument measuring knowledge of factors promoting good mental health among adolescents. The MHPK-10 had demonstrated good internal validity and test-retest reliability (r = 0.74) among adolescents. For each item, respondents rate items on 1–5 likert-type scale, the extent to which they are correct or wrong. The score range is 10–50, with a higher score indicating a higher positive mental health literacy [26].

This will be measured using a 35-item univariate scale, Mental Health Literacy Scale (MHLS). The scale will be adapted for use among adolescents. The score range is 35–160, with a higher score indicating a higher mental health literacy [27].

This will be measured using the 24-item Peer Mental Health Stigmatization Scale (PMHSS). For the present study, the 8-item personal stigma subscale will be used. Τhe scale demonstrated adequate discriminant validity, internal consistency (α = 0.75) and test-retest reliability in adolescents [28].

will be measured using the Reported and Intended Behaviour Scale (RIBS). Scores on the RIBS range from 4 to 20, with higher scores indicating more positive attitudes. The RIBS has a test-retest reliability of 0.75, and a Cronbach’s α of 0.86 [29].

This will be assessed using a 24-item Inventory of Attitudes towards Seeking Mental Health Services (IASMHS) scale. It consists of three subscales; Psychological Openness, Help-seeking Propensity, and Indifference to Stigma. The total help-seeking score is calculated as a sum of the subscale totals with higher scores indicate more favourable attitudes towards help-seeking [30].

A 6-item self-administered Kessler psychological distress scale (K6) with good internal consistency (Cronbach’s alpha = 0.84) will be used. The total score ranges from 0 to 24 with a higher score indicating higher distress [31].

A 25-item Connor-Davidson Resilience Scale (CD-RISC) will be used. The CD-RISC is a valuable measure to assess resilience among adolescents in low-income settings. Psychometric properties of the Kannada version of CD-RISC were established in a sample of adolescent girls from low-income settings. The total score ranges from 0 to 100, with higher scores reflecting greater resilience [32].

will measure socio-demographic details and contain case vignettes/questions to assess MH-FA knowledge and intentions to provide MH-FA (proxy measures of behaviour change).

A compelling body of evidence points to the potential influence of SUMS intervention on a range of adolescent health-related outcomes such as academic achievement, absenteeism rate, educational stress, suicidal ideation, bullying and substance use, which will be explored.

The pre-validated study instruments will be translated into local language and back-translated for conceptual equivalence. For pre-testing, a sample size of 42 is estimated to establish reliability of at least 0.85, against acceptable value of 0.7 (with α = 0.05; β = 0.20) for a minimum of 6 items [33]. The translated study instruments will be pre-tested on a representative sample for cultural relevance and comprehensibility and validated for internal consistency before their final inclusion. The final study instrument administered will be bilingual.

Positive mental health literacy measured using the 10-item Mental Health-Promoting Knowledge (MHPK-10) scale is considered primary outcome for the present study [26]. However, the Intra-Cluster Correlation for MHPK-10 score is unknown. Based on evidence from similar adolescents studies, we assumed a conservative and modest estimate of ICC (ρ) between 0.01 and 0.05 [34, 35]. From the Kolar District Report (as on 30/3/2016), an estimated average of 50 students is expected from grade-6 and 7 of each higher-primary schools. With a need for 4 schools per arm with 50 students per school, we powered the trial to be able to detect a standardised difference (difference in means/SD) of 0.37–0.56 (medium effect size) for MHPK-10 scores between intervention and control groups for a two-sided level of significance at 5% (α = 0.05) with 85% power. For the above assumption, the design effect varied from 1.5 to 3.5 for ICC (ρ) values from 0.01 to 0.05, respectively [36]. We expect a minimum sample size of 400 across 8 schools for 85% power. Even with a 5% loss to follow-up, the study will still have more than 80% power.

From the eligible higher-primary school-list obtained from the education department of Srinivaspura taluka, eight schools will be randomly selected using computer-generated random-number by an independent researcher. The selected schools will then be assigned to the intervention, and waitlist-control condition (receiving intervention after the post-assessment in intervention-group) by the independent researcher through the random-allocation sequence. To ensure allocation concealment, randomly selected schools will be assigned unique study numbers that will not be known to the independent researcher at the central office. The sequence will be delivered through sealed, opaque envelopes.

The selected-schools will be invited to participate in the study, and briefing-meetings will be conducted to inform principals of selected-schools regarding the study. Information on any initiatives/activities related to target outcomes in the selected-schools will be obtained. Local consortium and local stakeholders for education will be interacted to ensure minimal refusal of the selected schools. In case of refusal, the refusing school will be replaced with another school from the eligible school-list. A due care will be taken to prevent possible contamination so that no control-schools will be selected within 5 km radius of intervention-schools. An alternate covariate-constrained randomisation will be considered only if we do not reach an acceptable baseline balance through simple-randomisation.

Given the nature and complexity of intervention & its delivery, it will not be possible to completely blind or conceal the intervention from the teachers, students, and field-staff. The trial will be open-label. Nonetheless, the study-statistician will be blinded till the database is locked for final-analysis.

Enrolment will start after obtaining assent and parental-consent from the eligible students. In the case of multiple sections with > 60 students in each grade, one section will be randomly selected from each grade. The intervention will be provided to all students in the selected grades irrespective of their number. The teachers will be free to provide intervention for other sections, but data will not be collected.

For the schools randomised to the intervention arm, the teachers nominated by their designated superior officials will be trained on the curriculum resource guide content in a 3-day workshop. The teachers who provide consent to participate in the research, complete the training, stay in the selected-schools for the study period and deliver the intervention will be selected. Following baseline assessment of participating students, the trained teachers will then proceed with the implementation of SUMS Intervention Curriculum Resource Guide, which requires approximately 10–15 h of classroom time over two months. In the intervention delivery, the teachers will be given pedagogical flexibility but will be instructed to adhere to the standardised core content, recommended lesson plans and procedures to maintain fidelity (Table 2). Booster sessions will be provided at 2-months and 5-months following the initial intervention.

Quality assurance and data management

Trial-Monitoring: The Project-Assistant will check for intervention-delivery, protocol-adherence, data-collection and reporting using supervisory check-list during their monthly visits. Principal-Investigator will review this monthly visit reports during monthly review meetings. The central-research team (comprising of Principal-Investigator and other expert-collaborators) will have meetings once in 6 months at NIMHANS to review the progress, work plan, discuss and troubleshoot any unresolved field issues. A register will be maintained for all review meetings. Constant support will be obtained from the expert collaborators through tele-meetings.

A Trial Steering Committee (TSC) and Data Safety Monitoring Board (DSMB) will be constituted independently of the research team, the members of whom will have no conflict of interest. The TSC will comprise experienced experts to oversee the trial and independently evaluate the trial to monitor progress, intervention delivery, protocol adherence and data management. A three-member DSMB will monitor the data as the trial progresses to identify any emerging safety concerns for the study participants and problems in the study’s conduct. DSMB will decide on the continuation of trial following interim analysis.

Control-schools will continue to provide regular teaching as usual of the existing course to their students. The control group will receive the interventions at the end of the 12-month follow-up assessment in intervention-schools. The teachers in the waitlist control arm will be trained just one month before their scheduled intervention to prevent contamination.

An information letter detailing the intervention program and data collection along with consent-form will be sent to the parents/guardians of participating class for parental-consent. Parental-consent will be recorded with a signature/thumbprint. Existing school communication channels (letter, diary or parent’s teachers meeting) will be used to maximise the parental-consent for child participation. Parents will be provided an opportunity to contact the field-team to discuss the study and their participation. An attempt will be made to meet the non-responding parents to obtain their consent. Children without parental consent in the selected class will be permitted to attend intervention sessions, but data will not be collected from them.

The students may withdraw their participation at any point in time during the study. An attempt will be made to document the reasons for withdrawal.

Data will be collected using self-administered questionnaire. Students will complete the survey during class time in the presence of trained project assistant/ teacher to assist the children with reading, writing and answering any queries. Data will be collected at 4-timepoints from both intervention and control schools: baseline and 6-weeks, 6-months and 12-months post-intervention (Fig. 2). To maximise data completeness, all effort will be made to obtain data from absentee students through liaison with key school-staff.

Trial process. MHPK: Mental Health Promoting Knowledge; MHLS: Mental Health Literacy Scale; PMHSS: Peer Mental Health Stigmatization Scale; RIBS: Reported and Intended Behaviour Scale; IASMHS: Inventory of Attitudes towards Seeking Mental Health Services; K6: Kessler psychological distress scale; CD-RISC: Connor-Davidson Resilience Scale; MH-FA: First Aid in Mental Health. *Exploratory outcomes include academic achievement, absenteeism, educational stress, suicidality, bullying and substance use

We do not anticipate any risk to the participating students due to our interventions. However, potential discomfort due to sensitive questions of survey assessment related to self-perception and well-being cannot be ruled out when answering in the classroom. Due-care will be taken to ensure the privacy and confidentiality of students while filling the survey forms. A register & form will be maintained to record unexpected severe events during the trial. Any students who require professional mental help during the study will be referred to the district mental health team for further management.

The process evaluation will include concurrent fidelity assessment and a qualitative study (focus group/in-depth interviews) among students/teachers during the final stages of the trial to explore the implementation of the intervention and identify contextual factors associated with outcomes. Teachers will be provided with questionnaires to evaluate the Curriculum Guide and to provide feedback on their experience.

The study tools/measures will be examined for internal consistency. Demographic and baseline characteristics will be summarised using descriptive statistics. Principal-analyses will be intention-to-treat which will take into account clustering by the school and repeated measures. To assess the effectiveness of interventions, outcomes will be compared between two trial arms using linear-mixed-model analysis for continuous outcomes and generalised linear mixed models or generalised estimating evaluation (GEE) for binary outcomes. The analysis will include all participants with at least one outcome measurement at 6 weeks post-intervention. A per-protocol analysis will also be conducted along with intention-to-treat analysis to examine the influence of missing data patterns. Multiple imputation will be attempted for missing values. The analysis will be adjusted for potential confounders that are identified a-priori during the study. Subgroup analysis will be performed for important socio-demographic variables. Statistical significance will be set at p-value< 0.05, and Bonferroni’s correction will be made for multiple testing (if any).

For qualitative analysis, all the verbatims of interviews/group discussions will be transcribed and translated into English for thematic analysis.

Interim analyses is planned for the follow-up data collected at 6-weeks post-intervention and will be submitted to Data Safety & Monitoring Board (DSMB) for further review (Table ​(Table22).

The DSMB will be asked to advise stopping the trial if they have proof beyond doubt that intervention is futile. The trial’s stopping-rule will be based on evidence-of-futility in > 70% of outcome measures (both primary &secondary) at interim-analyses and critical feedback from the local stakeholders.

The trial was reviewed and funded by Indian Council of Medical Research (Id: 2017–4697 version F1 dated 02 September 2019). The trial was reviewed and approved by the Institute Ethics Committee, NIMHANS (No.NIMHANS/19^thIEC (BS&NS DIV.)/2019 on 2019-07-17. The trial was registered at Clinical Trials Registry-India with identification code: CTRI/2019/07/020394 dated 2019-07-29. Due to COVID-19 Pandemic and school closures, recruitment for the trial is anticipated after March 2022.