| Methods |
(High‐intensity vs low‐intensity data set) |
| Participants |
As data set 1 |
| Interventions |
High intensity (n = 102)
Low intensity (n = 51) |
| Outcomes |
As data set 1 |
| Notes |
‐ |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Treatment allocation based on a computer‐generated random numbers list obtained via the SPSS statistical package |
| Allocation concealment (selection bias) |
Low risk |
Randomisation schedule held at trial office, remote from the study environment; assignment to 1 of 3 treatment options by a telephone call to the trial office made by the study speech pathologist |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
All people involved in the study unaware of treatment allocation, apart from participants and the study speech pathologist who treated participants
Assigned to high‐intensity and low‐intensity groups |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
As above |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Outcome assessed by an independent speech pathologist, who was unaware of treatment allocation, every month for 6 months after randomisation |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
3 participants lost to follow‐up before 6‐month analysis |
| Selective reporting (reporting bias) |
Low risk |
All outcomes reported |
| Other bias |
Unclear risk |
None identified |
