跳至主要内容
临床试验/NCT04217460
NCT04217460招募中不适用

Intervention for Fluency Difficulty

University College, London1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年8月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Non-word Repetition (NWR)

研究概览

简要总结

The focus of the study is to identify children with word-finding difficulty and other speech and communication difficulties such as stuttering, a procedure referred to as screening. Ideally, investigators want to screen all children in the reception classes in the schools with which investigators work. The procedures were designed so that they work with children who speak English or those whose first language is not English. A second aim concerns what teachers can do when a child does not pass the screen. Investigators have developed a type of treatment designed for children who have either word-finding difficulty or fluency difficulty. This project concerns the intervention for children with word-finding difficulty.

The treatment is conducted in a quiet room with pairs of children. The children with word-finding difficulty in each group are assessed individually for about 10 min before the treatment starts to establish a baseline for assessing improvement using a standardized task that tests for word-finding difficulty. A recording is taken, similar to that investigators obtained at the screening phase. The training takes place over three weeks (one session a week of 20-30 minutes' duration). Word-finding difficulty and fluency are reassessed at the end of the three-week period and at follow-up one week later.

详细描述

The focus of the study is to identify children with word-finding difficulty and other speech and communication difficulties such as stuttering, a procedure referred to as screening. Ideally, investigators want to screen all children in the reception classes in the schools with which investigators work. The procedures were designed so that they work with children who speak English or those whose first language is not English. A second aim concerns what teachers can do when a child does not pass the screen. Investigators have developed a type of treatment designed for children who have either word-finding difficulty or fluency difficulty. This project concerns the intervention for children with word-finding difficulty.

The researcher will visit every participating child at school for approximately 10 minutes. Prior to that, the researcher will speak to the child's teacher to ensure that the sessions do not clash with any important class activities. Each child will be seen individually and will listen to a number of "nonsense" words one by one and will be asked to repeat the word. The child will be told that these are funny sounding made up word. The child will be audio-recorded while speaking to the researcher.

Each audio recording is then analysed anonymously at UCL for signs of fluency or word finding difficulty. All children occasionally show these signs and they are not usually a cause of concern. Some parents are then invited to volunteer their child for the experimental word-finding training based on these results. This does not necessarily mean that they have word-finding problems (e.g. for children acting as controls). Separate information sheets indicating what this involves will be given to parents.

Parents will also be given a link to a brief online questionnaire about the child's language history that they can fill out at their own time on their phone or computer. No identifiable information are collected and every parent will be assigned a number that matches the child's participation number. Only the researchers will have access to the questionnaire. There is no obligation on parents who have been contacted to have their children participate in the training.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

All details pseudo-anonymized before analysis.

入排标准

年龄范围
4 Years 至 11 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •matched to children with word-finding difficulty by age, gender and native language

排除标准

  • 未提供

研究组 & 干预措施

Intervention for fluency difficulty (controls)

Active Comparator

Behavioural intervention (children practice speaking specially constructed non-word materials). Intervention is the same for both arms, here this is for controls.

干预措施: Intervention for fluency difficulty (Behavioral)

Intervention for fluency difficulty (experimental)

Experimental

Behavioural intervention (children practice speaking specially constructed non-word materials). Intervention is the same for both arms, here this is for experimental group

干预措施: Intervention for fluency difficulty (Behavioral)

结局指标

主要结局

Non-word Repetition (NWR)

时间窗: 3 weeks intervention

This will be obtained to identify reception class children who have word finding difficulty (WFD) and fluency problems in schools. Samples of speech will be obtained to confirm children who have WFD or fluency difficulty.

Phonological Training

时间窗: 3 weeks intervention

The training procedure is delivered in a game form so that students can engage with and enjoy the test. All the following tests are conducted before and after training. Conversational speech samples are collected and analysed using a test for WFD (German, 1994) and one for fluency difficulty (Riley, 1994). Speech comprehension and letter sound knowledge tasks to assess educational impact.

Working Memory (WM) training

时间窗: 3 weeks intervention

This will involve three groups of children. For children with fluency difficulty, speech samples of about 10 minutes will be recorded before and at the end of WM training. Each speech sample will be assessed for %Stuttered Syllables (%SS) and Whole Word Repetition (%WWR) to obtain baseline measures and measurements following the intervention as well as in a follow up session. The intervention will be delivered to pairs of children. Two other groups of children who do not have fluency difficulty will take part either in a non-WM activity (group 1) using the same materials that will be used for the intervention group or the WM intervention (group 2).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Howell

Professor

University College, London

研究点 (1)

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