Pilot measures | Metric and aggregation as primary outcome measure | Time points |
---|---|---|
Recruitment rate | % participants of the target for each group are randomised | t0 (allocation) |
Retention rate | % participants of those randomised completing at least one post-treatment measure | t8 (1-month post-treatment) |
Completion of clinician-reported fidelity measure | % therapy sessions in each intervention where the dose tallies were was recorded | t1 to t6 (therapy) |
Therapy protocol adherence | % therapy sessions in each intervention where the minimal dose was achieved | t1 to t6 (therapy) |
Perceptual rating of treatment wordlists | % rated sessions | t(−1) and t1 to t8 (baseline, therapy, and post-treatment assessments) |
Patient-reported outcome measure Cleft-Q (functioning and distress subscales) | % completed questionnaires for each intervention arm | t(−1), t7, t8 (baseline and both post-treatment assessments) |
Patient-reported outcome measure ICS | % completed questionnaires for each intervention arm | t(−1), t7, t8 (baseline and both post-treatment assessments) |
Patient-reported experience measure | % completed questionnaires for each intervention arm | t8 (1-month post-treatment) |
Intervention acceptability questionnaire | % completed questionnaires for each intervention arm | t8 (1-month post-treatment) |