A pilot study to determine the feasibility of a cluster randomised controlled trial of an intervention to change peer attitudes towards children who stutter

Rizwana B. Mallick, Lehana Thabane, A.S.M. Borhan, Harsha Kathard

 While randomised controlled trials (RCTs) are considered the gold standard of research, prior study is needed to determine the feasibility of a future large-scale RCT study. Objectives: This pilot study, therefore, aimed to determine feasibility of an RCT by exploring: (1) procedural issues and (2) treatment effect of the Classroom Communication Resource (CCR), an intervention for changing peer attitudes towards children who stutter. Method: A pilot cluster stratified RCT design was employed whereby the recruitment took place first at school-level and then at individual level. The dropout rate was reported at baseline, 1 and 6 months post-intervention. For treatment effect, schools were the unit of randomisation and were randomised to receive either the CCR intervention administered by teachers or usual practice, using a 1:1 allocation ratio. The stuttering resource outcomes measure (SROM) measured treatment effect at baseline, 1 and 6 months post-intervention overall and within the constructs (positive social distance, social pressure and verbal interaction). Results: For school recruitment, 11 schools were invited to participate and 82% (n = 9) were recruited. Based on the school recruitment, N = 610 participants were eligible for this study while only n = 449 were recruited, where there was n = 183 in the intervention group and n = 266 in the control group. The dropout rate from recruitment to baseline was as follows: intervention, 23% (n = 34), and control, 6% (n = 15). At 1 month a dropout rate of 7% (n = 10) was noted in the intervention and 6% (n = 15) in the control group, whereas at 6 months, dropout rates of 7% (n = 10) and 17% (n = 44) were found in the intervention and control groups, respectively. For treatment effect on the SROM, the estimated mean differences between intervention and control groups were (95% Confidence Interval (CI): -1.07, 5.11) at 1 month and 3.01 (95% CI: -0.69, 6.69) at 6 months. A statistically significant difference was observed at 6 months on the VI subscale of the SROM, with 1.35 (95% CI: 0.58, 2.13). Conclusion: A high recruitment rate of schools and participants was observed with a high dropout rate of participants. Significant differences were only noted at 6 months post-intervention within one of the constructs of the SROM. These findings suggest that a future RCT study is warranted and feasible.