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Article History

Received: 10 October 2022

Accepted: 10 March 2023

First Online: 23 March 2023

Declarations

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: Ethics approval for this study was granted by the University College London (UCL) Research Ethics Committee (6735/009 and 6735/014). Research data will be processed and stored in line with the General Data Protection Regulation (GDPR). Schools that express an interest in taking part and are deemed eligible will be required to have a member of their senior leadership team sign a Memorandum of Understanding and data sharing agreement.<i>Pupil data</i>: Consent for pupils to take part will require different processing depending on the data being collected. For outcome (effectiveness) data, opt-out consent will be used when sending letters to parents/carers of pupils who have been selected by schools to take part. Parents/carers who wish to opt out their children will be asked to return an opt-out form to the research team. A survey password will not be created for pupils that are opted out, and this is flagged to schools in a timely manner to prevent these pupils from taking part in the surveys. GDPR-compliant data deletion processes will be enforced when pupils are opted out after taking part in the surveys.Pupils whose parents have not opted out of the evaluation will be given the option to assent to take part through reading an online information sheet and ticking an online assent form. Pupils that start the survey can stop and/or opt out at any time. Pupils that do not tick the assent form will not be allowed to complete the survey. All information sheets outline confidentiality procedures for collecting, processing and storing data. Teachers are asked not to look directly at pupils’ screens when they are filling out answers. They are also provided with a crib sheet of the more difficult words in the survey that young people may struggle with, in order for them to assist pupils from the front of the classroom.<i>Other survey data</i>: Opt-in consent will be required for all other data, including all surveys completed by staff.<i>Qualitative data</i>: Opt-in consent will be required for all interviews and focus groups. All individuals will be required to read an information sheet, detailing what will happen, and for those that are happy to proceed, to sign a consent form.For pupils under the age of 16, schools will send letters home to pupils’ parents/guardians, and those that are happy for their young people to take part will be required to sign a consent form. Prior to focus groups taking place, pupils will be required to read an information sheet and tick an assent form stating that they are happy to take part. Those who do not assent will not take part.<i>Observations</i>: As no individual or personal data will be collected for observations, consent/assent will not be required.Monitoring of adverse events: Adverse events (AEs), defined as a negative, emotional and behavioural occurrence, or sustained deterioration in a research participant, will be captured as part of the study. This includes serious adverse events (SAEs) which are a threat to life: suicidal ideation, suicidal intent, hospitalisation due to psychiatric of use of substances and death including suicide. Other adverse events: violent behaviour, self-harm or any other event that an individual feels it is important to report, will also be captured. School safeguarding leads will judge whether they believe the AE is likely related to the intervention.The ongoing conduct and progress of this study are monitored by an independently chaired Data monitoring committee (DMC). On becoming aware of SAEs, the chief investigator/trials manager will report all SAEs, or AEs which are likely to be related to the intervention or research, to the DMC within two working days. AEs thought to be unlikely related to the intervention or research should be reported within five working days and will be collated and reported quarterly to the DMC. The UCL Research Ethics Committee will also be informed of AEs and SAEs using the same mechanisms. School and research safeguarding protocols will be followed as standard in addition to the reporting and documenting of AEs. The DMC is responsible for making recommendations to the Department for Education regarding the stopping or continuing of the trial.Trial sponsor: The trial is sponsored by University College London.

: The authors declare that they have no competing interests.