Trials (Nov 2018)
A cluster randomised trial of a classroom communication resource program to change peer attitudes towards children who stutter among grade 7 students
Abstract
Abstract Background Classroom-based stuttering intervention addressing negative peer attitudes, perceptions, teasing and bullying of children who stutter (CWS) is required as part of holistic stuttering management because of its occurrence in primary school. This study was conducted in 2017, in 10 primary schools in the Western Cape, South Africa within lower (second and third) and higher (fourth and fifth) quintiles. Objectives The primary objective of this study was to determine treatment effect at six months after intervention of grade 7 participants (Classroom Communication Resource [CCR] intervention versus no CCR) using global Stuttering Resource Outcomes Measure (SROM) scores in school clusters. The secondary objective was to determine grade 7 participant treatment effect on the SROM subscales including Positive Social Distance (PSD), Social Pressure (SP) and Verbal Interaction (VI). The subgroup objective was to determine any difference in the primary outcome between schools between and across quintile clusters (lower and higher). Methods Once schools were stratified into lower and higher quintile (which are defined according to geographical location, fee per school and resources) subgroup clusters, schools were assigned randomly to control and intervention groups consisting of grade 7 participants who were typically aged ≥ 11 years. Teachers received 1 h of training before administering the single-dose CCR intervention over a 60–90-min session. The CCR intervention included a social story, role-play and discussion. All participants viewed a video of a CWS and stuttering was defined at baseline. The SROM measured peer attitudes at six months after intervention. Randomisation was stratified by quintile group using a 1:1 allocation ratio. Full blinding was not possible; however, the outcome assessor was partially blinded and the analyst was also blinded. Generalised estimating equations (GEE) was used assuming an exchangeable correlation structure to analyse the data adopting an intention-to-treat principle. Multiple imputation was used to handle missing data. Criterion for statistical significance was set at alpha = 0.05. Results Ten schools were randomly allocated to control (k = 5) and intervention groups (k = 5), with n = 223 participants allocated to intervention and n = 231 to control groups. A total of 454 participants completed the SROMs in control (n = 231) and intervention (n = 223) groups and were analysed at baseline and six months after intervention. There was no statistically significant difference on the global SROM score (mean difference − 0.11; 95% confidence interval [CI] − 1.56–1.34; p = 0.88). There were also no significant differences on SROM subscales: PSD (mean difference 1.04; 95% CI − 1.02–311; p = 0.32), SP (mean difference − 0.45; 95% CI − 1.22–0.26; p = 0.21) and VI (mean difference 0.05; 95% CI − 1.01–1.11; p = 0.93). Additionally, there was no significant subgroup effect on the global SROM score (lower versus higher quintile subgroups) (interaction p value = 0.52). No harms were noted or reported. Conclusion No statistically significant differences were noted. It is possible that the time frame was too short to note changes in peer attitudes and that further study is required to confirm the findings of this study. Trial registration Clinicaltrials.gov, NCT03111524. Registered on 9 March 2017.