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Table 2 Quality assurance and data management

From: Project SUMS (scaling up of mental health in schools): design and methods for a pragmatic, cluster randomised waitlist-controlled trial on integrated school mental health intervention for adolescents

Field-team: The field-team will comprise of Project-Assistant who will be trained in standard protocols of questionnaire administration for data collection, coordinate with local stakeholders, monitor compliance of intervention protocol and its deviations and also conduct public-engagement activities.

Post-recruitment retention strategies: For the Project-Assistant, all the activities required to achieve the trial goals will be communicated clearly. A weekly meeting will be held to sort out the field related issues. In addition, the teachers, principals, and other key stakeholders will be informed on the trial’s status and progress through newsletters.

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.

Intervention Fidelity: Teachers will be encouraged to fill a protocol-adherence checklist. The educational-intervention delivered by the teacher will be audio-recorded to assess fidelity of intervention delivery. A random sample of audiotaped sessions will be evaluated for each teacher using fidelity checklists for intervention-delivery based on the standardised core content of the SUMS intervention curriculum resource guide. Feedback will be provided to support the booster-training sessions. Our fidelity assessment will also incorporate feedback and recommendations of the independent evaluation and reports of supervisory-checklist.

Data Management: The study will have meaningful engagement with key stakeholders across all study phases. All data stored securely in-line with our data-management protocol will protect the confidentiality of participants. Any personal identifiers of study participants will be removed before analysis. Audiotapes and transcripts containing participants identity (if any) will be destroyed post-analysis of data. Participant’s identity will not be revealed in any of the publications related to this research. The principal investigator will have access to the final trial dataset.