Promotion of mental health and prevention of violence and substance use Other
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The study population is defined as students in year 8 (aged 12-13 years) at baseline plus all teachers. All student-reported measures are suitable for students in this age-group. The research will be inclusive, including of special educational needs and disability (SEND) students. No students deemed competent by teachers to complete data collection will be excluded from recruitment unless they do not consent to, or their parents withdraw them from, the research. Those who have mild learning disabilities or limited English will be supported to complete the questionnaire by researchers.
Exclusion criteria
Exclusion criteria: Students not deemed competent by teachers to complete data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 03/11/2025: For this pilot trial, the primary outcome is assessment of criteria for progression to phase III RCT as follows: 1. Randomisation occurs and 5+ schools continue; 2. Interventions achieve 70+% fidelity and reach; 3. Interventions acceptable to 70+% of students and teachers; 4. Student survey response rates are 80+% in 5+ schools; and 5. Informed by qualitative research, hypotheses developed about how contextual factors affect intervention implementation and mechanisms. The precise metrics used to assess implementation fidelity and acceptability were to be defined in phase one when intervention materials are optimised. These have been defined as follows: 1. Our progression criteria for randomisation, response rates and qualitative research are self-explanatory and do not require further elaboration. 2. Our progression criteria for intervention fidelity and reach has been subdivided into the following four subcriteria (measured during intervention delivery via logbooks and at 12-month follow-up via student survey): 70% of students in 3 or more intervention schools submit at least one completed booklet; 70% of teachers in 3 or more intervention schools complete at least one online session; of those students submitting a booklet, 70% of the spaces where students are asked to respond to questions are completed in 3 or more intervention schools; and of those teachers completing an online exercise, 70% of the spaces where teachers are asked to respond to questions are completed in 3 or more intervention schools. 3. Our progression criteria for acceptability has been subdivided into the following two subcriteria (measured at 12-month follow-up via student and teacher surveys): 70+% of students in 3 or more intervention schools responding to the endline survey answer yes to a question about the acceptability of the intervention; and 70+% of teachers in 3 or more intervention schools responding to the endline survey answer y | — |
Secondary
| Measure | Time frame |
|---|---|
| The study will assess primary and secondary outcome measures for use in a phase III trial: Co-primary outcomes 1. Student-reported psychological difficulties assessed via Strengths and Difficulties Questionnaire by student survey at 12-month follow-up 2. Student-reported mental wellbeing via Short Warwick Edinburgh wellbeing scale by student survey at 12-month follow-up Student-reported secondary outcomes: 1. Student reported aggression (Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale) by student survey at 12-month follow-up 2. Student reported bullying victimisation and perpetration in past 2 months (Revised Olweus Bully/Victim Questionnaire) by student survey at 12-month follow-up 3. Student-reported substance use (tobacco, alcohol and drug use) assessed using existing NHS measures by student survey at 12-month follow-up 4. Student-reported Child Health Utility (CHU)9D measure by student survey at 12-month follow-up Other secondary outcomes: 1. Student exclusions and attendance at 12-month follow-up (routine data) 2. Teacher-reported perceived behaviour of students (Pupil Behaviour Questionnaire by teacher survey at 12-month follow-up 3. Teacher-reported self-efficacy (Teacher Sense of Efficacy scale) by teacher survey at 12-month follow-up 4. Teacher-reported burnout (Maslach Burnout Inventory) by teacher survey at 12-month follow-up | — |
Countries
England, United Kingdom