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

机译:一项课堂交流资源计划的集群随机试验,旨在改变同龄人对7年级学生口吃儿童的态度

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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.
机译:基于课堂的口吃干预措施是应对口吃的负面同伴的态度,看法,取笑和欺凌行为(CWS),这是整体口吃管理的一部分,因为这种情况发生在小学。这项研究于2017年在南非西开普省的10所小学中(较低,第二和第三)和较高(第四和第五)的五分之一中进行。这项研究的主要目的是使用学校集群中的全球口吃资源成果评估(SROM)分数,确定7年级参与者干预后六个月的治疗效果(课堂交流资源[CCR]干预与否)。次要目标是确定7年级参与者对SROM子量表的治疗效果,包括积极的社会距离(PSD),社会压力(SP)和言语互动(VI)。该亚组目标是确定五分之一群集之间和之间(较低和较高)的学校之间的主要结局是否存在差异。一旦将学校分为较低和较高的五分位数(根据地理位置,每所学校的学费和资源划分)分组,将学校随机分配到对照组和干预组,这些组由通常≥11岁的7年级参与者组成。在接受60-90分钟的课程中,在进行单剂量CCR干预之前,教师接受了1小时的培训。 CCR干预包括社交故事,角色扮演和讨论。所有参与者都观看了CWS的视频,并且口吃是在基线时定义的。 SROM在干预后六个月测量了同伴的态度。按五分位数组使用1:1分配比率对随机分组进行分层。全盲是不可能的。但是,结果评估者部分失明,分析师也失明。使用通用估计方程(GEE),假设其具有可交换的相关结构,则采用意向性处理原理来分析数据。多重插补用于处理丢失的数据。统计显着性标准设定为α≥0.05。随机分配了10所学校作为对照组(k?=?5)和干预组(k?=?5),其中n?=?223参与者分配给干预,而n?=?231分配给对照组。共有454名参与者完成了对照组(n?=?231)和干预(n?=?223)组的SROM,并在基线和干预后六个月进行了分析。总体SROM评分没有统计学上的显着差异(平均差异≤0.11; 95%置信区间[CI]≤1.56-1.34; p≤0.88)。在SROM子量表上也没有显着差异:PSD(平均差异1.04; 95%CI ≤1.02–311;p≥0.32),SP(平均差异0.45; 95%CI≤1.22-0.26; p α=α0.21)和VI(均差0.05; 95%CI≤1.01-1.11; p = 0.93)。此外,对总体SROM评分(较低的五分之一组与较高的五分之一子组)没有显着的亚组影响(交互作用p值≥0.52)。没有发现或报告任何危害。没有发现统计学上的显着差异。时间框架可能太短而无法记录同伴态度的变化,因此有必要进一步研究以确认这项研究的结果。 Clinicaltrials.gov,NCT03111524。 2017年3月9日注册。

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