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

Abstract

BackgroundWhile 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.ObjectivesThis 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.MethodA 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).ResultsFor 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).ConclusionA 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.

A cluster randomised trial of a classroom communication resource program to change peer attitudes towards children who stutter among grade 7 students

“…quintile group [lower versus higher] × intervention [CCR versus usual practice]). Subgroup analysis is supported by a previous study which showed schools behaving as clusters and as quintiles [ 20 ], while no large-scale findings have been reported. Treatment effect was additionally analysed in terms of the direction and magnitude.…”

“…A stratified cluster randomised controlled trial (RCT) was conducted using a 1:1 allocation ratio whereby schools were the unit of randomisation and were stratified into two quintile groups (lower versus higher quintile groups). No changes were made to the methods after the trial commenced as a previous pilot study [ 20 ] guided this study.…”

“…A generalised estimating equations (GEE) model was implemented using six-month post-intervention (adjusting from baseline) mean global SROM scores. Sample size and computation was guided by previous studies [ 16 , 20 , 25 , 26 ] assuming normally distributed global SROM scores with a mean difference of 5.25 (77.91 intervention group and 72.66 control group), ICC (intra-school correlation coefficient) of 72.70 and a common within-group standard deviation of 11.90.…”

Lessons learned about development and assessment of feasibility of tools for health and rehabilitation services

“…However, researchers also learned that there were limitations in the procedural aspects of implementation which impacted negatively on the sensitivity of the protocol. Similarly, in case study 2, the pilot study [20] informed the design of an RCT through assessing the potential treatment effect of the CCR intervention as well as the feasibility of recruiting and retaining participants. The study concluded that an RCT was feasible subject to strengthening several procedural aspects of the process.…”