Data | Cluster level | Individual level |
---|---|---|
Acceptability of RECALL intervention and its manual to health professionals and teachers | Measures of compliance and fidelity. | Qualitative data: • Semi-structured interviews • Comments on intervention logs • Feedback from pre-study training provided for health professionals. |
Compliance | Number of sessions delivered in each cluster | Qualitative data from semi-structured interviews including reasons for any sessions not being completed. |
Fidelity | Structured observations by research team following Carroll et al. (2007) Research team records of any advice given. | – |
Recruitment, consent and sampling procedures | Number and proportion of schools: • Meeting eligibility criteria • Approached • Principals who consent • Teachers who consent Number and proportion of children identified by teachers in each of the 3 sub-groups. | Number and proportion of parents who consent |
Attendance levels and loss to follow-up. | Number of completed interventions | Number of standardised assessments, teacher rating scales and parent rating scales completed post-intervention |
Acceptability of randomisation | School consent rates and reasons given for participation/non-participation. | Qualitative data: teachers’ perspectives on random allocation. |
Acceptability of active control intervention as a comparator to RECALL | – | Qualitative data: health professionals’ perspectives on similarities/differences between the programmes. Observations of delivery by research team. |
Exploration of education as usual | – | Qualitative data–semi-structured interviews with teachers in the education as usual control arm. |
Acceptability of outcome measures for the children, teachers and RISE teams | – | Number of completed assessments for each child at each time point Number lost to follow-up and reasons why if possible Quality of audio-data will be reviewed Qualitative data: semi-structured interviews |
Unexpected adverse effects | Any unanticipated effects will be recorded by the RISE team and teachers | |
Blinding | Qualitative data: recording if blinding maintained at end of study. |