Montreal Fluency Centre, Canada; The University of Newcastle, Australia.
J Fluency Disord. 2009 Dec;34(4):279-90. doi: 10.1016/j.jfludis.2009.11.001. Epub 2009 Nov 20.
This Phase I trial sought to establish (1) whether the Lidcombe Program is viable for school-age children, (2) whether there is any indication that it requires modification for school-age children, (3) whether treatment effects are durable, (4) how many treatment sessions appear to be required to significantly reduce stuttering frequency and (5) whether there is an association between follow-up period and relapse tendency.
Twelve children were treated, and one required an addition to the Lidcombe Program. The results for this child were excluded from group analysis, leaving a group of 6-10 year-olds. A retrospective method was used using routine pre-treatment clinic recordings. At follow-up, all children were telephoned and audio-recorded three times at random times during the day within a 7-10-day period.
A blinded observer's mean percent syllables stuttered score pre-treatment was 9.2 and 1.9 at follow-up. No association was found between follow-up period and stuttering rates. The mean syllables per minute score pre-treatment was 145.8 and 179.3 at follow-up. These results were attained in a median of eight clinic visits with a range of 6-10 visits.
Procedurally, the Lidcombe Program is viable for school-age children and parents report enjoyment in administering it. There appears to be a treatment effect that can be attained in a reasonable number of clinical hours. These results compel continued exploration with young school-aged children in subsequent Phase II and III studies.
The reader will be able to: (1) summarize the status of clinical trials for stuttering school-age children, (2) describe the phases of clinical trial development, (3) evaluate outcomes the Lidcombe Program for a school-age population in terms of stuttering reduction and treatment time, (4) evaluate the suitability of the Lidcombe Program with population of school-age stuttering children, and (5) provide an interpretation of the finding of no correlation between follow-up and post-treatment stuttering rates.
本阶段 I 试验旨在确定（1）利德科姆程序是否适用于学龄儿童，（2）是否有任何迹象表明它需要针对学龄儿童进行修改，（3）治疗效果是否持久，（4）需要多少次治疗来显著减少口吃频率，以及（5）随访期与复发倾向之间是否存在关联。
对 12 名儿童进行了治疗，其中 1 名儿童需要在利德科姆程序中增加内容。这名儿童的结果被排除在组分析之外，留下了一组 6-10 岁的儿童。采用回顾性方法，使用常规治疗前诊所录音。在随访中，所有儿童均在 7-10 天的随机时间内通过电话和录音三次。
一名盲法观察者的平均音节口吃率治疗前为 9.2%，随访时为 1.9%。未发现随访期与口吃率之间存在关联。治疗前平均音节每分钟为 145.8，随访时为 179.3。这些结果是在中位数为 8 次就诊的情况下获得的，就诊次数范围为 6-10 次。
从程序上讲，利德科姆程序适用于学龄儿童，家长报告说喜欢实施该程序。似乎可以在合理数量的临床时间内达到治疗效果。这些结果促使在随后的 II 期和 III 期研究中对年轻的学龄儿童进行进一步探索。
读者将能够：（1）总结学龄儿童口吃临床试验的现状，（2）描述临床试验开发的阶段，（3）评估利德科姆计划对学龄人群口吃减少和治疗时间的效果，（4）评估利德科姆计划对学龄口吃儿童人群的适用性，以及（5）对口吃率与随访之间无相关性的发现进行解释。
