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临床试验/NCT07815249
NCT07815249招募中不适用

A Single Case Experimental Design Study of Motor Speech Treatment for Children With Childhood Apraxia of Speech and Rare Genetic Conditions

Murdoch Childrens Research Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年7月1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
20
试验地点
1
主要终点
Change in accuracy of trained speech targets following speech intervention where accuracy is measured by the percentage of words correct on an individualised probe word list

研究概览

简要总结

The goal of this trial is to learn if speech therapy can improve speech accuracy in children with rare genetic conditions and childhood apraxia of speech (CAS). This study will look at each child individually.

Participants will complete 4-weeks of motor speech therapy (3 times per week) and will complete speech assessments before, during and after therapy to measure change. The motor speech therapy will be either Rapid Syllable Transition Treatment (ReST) or Dynamic Temporal and Tactile Cueing (DTTC). Assignment to ReST or DTTC will be based on the participant's age and speech ability. This trial will not compare ReST and DTTC.

详细描述

This study uses a single case experimental design (SCED) approach with a multiple baseline design.

Participants will be allocated to either speech movement therapy approach (Dynamic Temporal and Tactile Cueing [DTTC] or Rapid Syllable Transition Treatment [ReST]) (based on clinical and speech characteristics). Each participant is allocated to one treatment only. Each participant will follow an A-B-F pattern as follows.

A: Baseline: Within each group, participants will be randomly allocated to baseline lengths of 3, 4 or 5 probes (i.e., providing experimental control). Baseline probes will be collected twice per week (i.e., baseline duration will run from 1.5 to 2.5 weeks)

B: Treatment: All participants will complete a 4-week treatment block (3 sessions per week) with a qualified speech pathologist.

F: Follow-up: Maintenance probes will be completed at 1 week, 4 weeks and 8 weeks post-treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 3 and 16 years, with a confirmed genetic condition and a diagnosis of childhood apraxia of speech; English as the primary language at home; able to participate in speech therapy 3 times per week for 4 weeks

排除标准

  • Diagnosis of an acquired brain or movement condition likely to affect speech; currently receiving motor speech therapy in the community; diagnosis of a behavioural condition likely to impact engagement (i.e., unable to participate for 45 minutes, unable to focus attention at the speech therapist's face for a few minutes at a time, unable to say any sounds and/or use gesture, unable to try to copy speech therapist; intolerant to touch (if touch cues are needed for DTTC)

研究组 & 干预措施

Motor speech therapy

Experimental

DTTC or ReST

干预措施: Rapid Syllable Transition Treatment (Behavioral)

Motor speech therapy

Experimental

DTTC or ReST

干预措施: Dynamic Temporal and Tactile Cueing (Behavioral)

结局指标

主要结局

Change in accuracy of trained speech targets following speech intervention where accuracy is measured by the percentage of words correct on an individualised probe word list

时间窗: Baseline (3, 4 or 5 baselines depending on baseline allocation, complete twice weekly pre-treatment), Treatment week 1, Treatment week 2, Treatment week 3, Treatment week 4, 1-week post treatment, 4-weeks post treatment, 8-weeks post treatment.

This will be used to determine changes in accuracy of trained speech targets following speech intervention. Accuracy will be determined using an individualised probe word list (a higher percentage of correct words demonstrates higher accuracy).

次要结局

  • Change in accuracy of untrained speech targets following speech intervention where accuracy is measured by the percentage of words correct on an individualised probe word list(Baseline (3, 4 or 5 baselines depending on baseline allocation, complete twice weekly pre-treatment), Treatment week 1, Treatment week 2, Treatment week 3, Treatment week 4, 1-week post treatment, 4-weeks post treatment, 8-weeks post treatment.)
  • Change in the percentage of subjective (listener-based) single word speech intelligibility following speech intervention measured using the Preschool/Childhood Speech Intelligibility Measure (PSIM/CSIM)(Baseline (3, 4 or 5 baselines depending on baseline allocation, complete twice weekly pre-treatment), Treatment week 1, Treatment week 2, Treatment week 3, Treatment week 4, 1-week post treatment, 4-weeks post treatment, 8-weeks post treatment.)
  • Change in subjective (listener-based) sentence level (connected speech) intelligibility following speech intervention measured using the Assessment of the Intelligibility of Dysarthric Speech (ASSIDS)(Baseline (3, 4 or 5 baselines depending on baseline allocation, complete twice weekly pre-treatment), Treatment week 1, Treatment week 2, Treatment week 3, Treatment week 4, 1-week post treatment, 4-weeks post treatment, 8-weeks post treatment.)
  • Change in objective measures of speech timing following speech intervention measured using acoustic measures obtained from three short speech tasks (2-minute monologue, diadochokinetic rate (i.e., "pa-pa-pa") and sustained vowel.(Baseline (3, 4 or 5 baselines depending on baseline allocation, complete twice weekly pre-treatment), Treatment week 1, Treatment week 2, Treatment week 3, Treatment week 4, 1-week post treatment, 4-weeks post treatment, 8-weeks post treatment.)
  • Change in objective measures of vocal control following speech intervention measured using acoustic measures obtained from three short speech tasks (2-minute monologue, diadochokinetic rate (i.e., "pa-pa-pa") and sustained vowel.(Baseline (3, 4 or 5 baselines depending on baseline allocation, complete twice weekly pre-treatment), Treatment week 1, Treatment week 2, Treatment week 3, Treatment week 4, 1-week post treatment, 4-weeks post treatment, 8-weeks post treatment.)
  • Change in objective measures of vocal quality following speech intervention measured using acoustic measures obtained from three short speech tasks (2-minute monologue, diadochokinetic rate (i.e., "pa-pa-pa") and sustained vowel.(Baseline (3, 4 or 5 baselines depending on baseline allocation, complete twice weekly pre-treatment), Treatment week 1, Treatment week 2, Treatment week 3, Treatment week 4, 1-week post treatment, 4-weeks post treatment, 8-weeks post treatment.)
  • Tolerability for the parent/caregiver and participant measured using a 5-point Likert scale of strongly agree to strongly disagree(Completed at end of 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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