Table 5 Candidate primary and secondary outcome measures: percentage/proportion (standard deviation) and numbers of participants analysed
Candidate primary outcome: Percentage targeted consonants correct, measured as the percentage of treated speech sounds produced correctly in words, using therapists’ auditory assessment | ||
Time point | Articulatory therapy | U-VBF therapy |
Baseline | 13 (33), n = 6 | 14 (35), n = 9 |
Therapy session 1 | 16 (37), n = 8 | 19 (39), n = 9 |
Therapy session 2 | 21 (41), n = 6 | 25 (43), n = 10 |
Therapy session 3 | 27 (44), n = 8 | 14 (35), n = 11 |
Therapy session 4 | 26 (44), n = 8 | 14 (35), n = 11 |
Therapy session 5 | 26 (44), n = 7 | 29 (46), n = 8 |
Therapy session 6 | 12 (32), n = 6 | 21 (41), n = 8 |
1 week after intervention | 43 (50), n = 6 | 22 (41), n = 10 |
1 month after intervention | 39 (49), n = 7 | 37 (48), n = 9 |
Carer-reported intelligibility for children, measured using the Intelligibility in Context Scale | ||
Baseline | 0.72 (0.08), n = 8 | 0.75 (0.12), n = 11 |
1 week after intervention | 0.76 (0.09), n = 8 | 0.76 (0.12), n = 10 |
1 month after intervention | 0.71 (0.05), n = 7 | 0.78 (0.08), n = 10 |
Patient- and carer-reported quality of life, measured using the CLEFT-Q speech function scale | ||
Baseline | 54.57 (7.35), n = 7 | 50.45 (15.40), n = 11 |
1 week after intervention | 60.25 (9.44), n = 8 | 53.90 (14.87), n = 10 |
1 month after intervention | 53.86 (9.08), n = 7 | 61.60 (16.79), n = 10 |
Patient- (aged ≥ 8) and carer-reported (aged < 8) quality of life, measured using the CLEFT-Q speech distress scale | ||
Baseline | 72.43 (15.28), n = 7 | 66.00 (15.26), n = 11 |
1 week after intervention | 76.57 (16.88), n = 7 | 70.00 (16.19), n = 9 |
1 month after intervention | 77.86 (14.37), n = 7 | 70.40 (19.18), n = 10 |
Patient and carer satisfaction with both interventions, measured using the Experience of Service Questionnaire 1 month after intervention | ||
1 month after intervention | Results reported in [21] | |