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Table 3 Acceptability and feasibility data at the cluster and individual levels

From: A classroom-based intervention targeting working memory, attention and language skills in 4–5 year olds (RECALL): study protocol for a cluster randomised feasibility trial

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.