Intervention for Fluency Difficulty
FIST
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 24, 2018
CompletedFirst Submitted
Initial submission to the registry
December 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 3, 2020
January 1, 2020
3.4 years
December 29, 2019
January 2, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Non-word Repetition (NWR)
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.
3 weeks intervention
Phonological Training
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.
3 weeks intervention
Working Memory (WM) training
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).
3 weeks intervention
Study Arms (2)
Intervention for fluency difficulty (controls)
ACTIVE COMPARATORBehavioural intervention (children practice speaking specially constructed non-word materials). Intervention is the same for both arms, here this is for controls.
Intervention for fluency difficulty (experimental)
EXPERIMENTALBehavioural intervention (children practice speaking specially constructed non-word materials). Intervention is the same for both arms, here this is for experimental group
Interventions
Children are required to speak materials they hear on recordings. The materials are not words, but contain sound sequences that occur in their language and English.
Eligibility Criteria
You may qualify if:
- matched to children with word-finding difficulty by age, gender and native language
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peter Howell
London, WC1H0AP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- All details pseudo-anonymized before analysis.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 29, 2019
First Posted
January 3, 2020
Study Start
August 24, 2018
Primary Completion
December 31, 2021
Study Completion
December 31, 2024
Last Updated
January 3, 2020
Record last verified: 2020-01