Mallick Rizwana, Kathard Harsha, Borhan A S M, Pillay Mershen, Thabane Lehana
University of Cape Town, Rondebosch, Cape Town, South Africa.
McMaster University, Hamilton, Canada.
Trials. 2018 Nov 29;19(1):664. doi: 10.1186/s13063-018-3043-3.
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.
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).
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.
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.
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.
Clinicaltrials.gov, NCT03111524 . Registered on 9 March 2017.
由于小学阶段会出现对口吃儿童(CWS)的负面同伴态度、看法、取笑和欺凌现象,因此基于课堂的口吃干预作为整体口吃管理的一部分是必要的。本研究于2017年在南非西开普省的10所小学进行,这些小学处于较低(二年级和三年级)和较高(四年级和五年级)五分位数区间。
本研究的主要目的是使用学校集群中的全球口吃资源结果测量(SROM)分数,确定七年级参与者在干预六个月后的治疗效果(课堂交流资源[CCR]干预与无CCR干预)。次要目的是确定七年级参与者对SROM子量表的治疗效果,包括积极社会距离(PSD)、社会压力(SP)和言语互动(VI)。亚组目的是确定五分位数集群(较低和较高)之间及各集群内学校之间主要结局的差异。
一旦学校被分层为较低和较高五分位数(根据地理位置、每所学校的费用和资源定义)亚组集群,学校就被随机分配到由通常年龄≥11岁的七年级参与者组成的对照组和干预组。教师在进行为期60 - 90分钟的单剂量CCR干预之前接受1小时的培训。CCR干预包括一个社会故事、角色扮演和讨论。所有参与者观看一段口吃儿童的视频,并在基线时对口吃进行定义。SROM在干预六个月后测量同伴态度。使用1:1分配比例按五分位数组进行随机分层。不可能完全设盲;然而,结局评估者部分设盲,分析者也设盲。采用广义估计方程(GEE),假设可交换相关结构,采用意向性分析原则分析数据。使用多重填补法处理缺失数据。统计学显著性标准设定为α = 0.05。
10所学校被随机分配到对照组(k = 5)和干预组(k = 5),223名参与者被分配到干预组,231名参与者被分配到对照组。共有454名参与者在对照组(n = 231)和干预组(n = 223)完成了SROM,并在基线和干预六个月后进行分析。全球SROM分数无统计学显著差异(平均差 -0.11;95%置信区间[CI] -1.56 - 1.34;p = 0.88)。SROM子量表也无显著差异:PSD(平均差1.04;95% CI -1.02 - 3.11;p = 0.32)、SP(平均差 -0.45;95% CI -1.22 - 0.26;p = 0.21)和VI(平均差0.05;95% CI -1.01 - 1.11;p = 0.93)。此外,全球SROM分数无显著亚组效应(较低与较高五分位数亚组)(交互p值 = 0.52)。未观察到或报告有不良事件。
未观察到统计学显著差异。可能是时间框架过短,无法观察到同伴态度的变化,需要进一步研究来证实本研究的结果。
Clinicaltrials.gov,NCT03111524。于2017年3月9日注册。