Word Finding DifficultyFISTNCT04217460
Intervention for Fluency Difficulty
A study testing Intervention for fluency difficulty in people with Word Finding Difficulty and Communication Disorders, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Word Finding Difficulty, Communication Disorders
- What is being tested?
- Intervention for fluency difficulty
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- matched to children with word-finding difficulty by age, gender and native language
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Peter Howell
London, WC1H0AP
Peter Howell, PhD, +4402076797566 ext. +4402076797566, p.howell@ucl.ac.uk
Roa'a AlSulaiman, +4402076797566 ext. +4402076797566, roaa.al-sulaiman.17@ucl.ac.uk
About this study
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.
Read the detailed description
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.
- Conditions
- Word Finding Difficulty, Communication Disorders
- Being tested
- Intervention for fluency difficulty
- Medical subject headings
- Anomia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for fluency difficultyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention for fluency difficulty |
| 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 Receives: Behavioral: Intervention for fluency difficulty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 3 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start24 Aug 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Word Finding DifficultyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Children screened for word-finding difficulty. Children at risk are matched with controls who do not have word-finding difficulty. Blind intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Howell, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217460
- Sponsor's protocol ID
- phowell
- Acronym
- FIST
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Pseudoanonymized in parents agree
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Fluency Difficulty
- ClinicalTrials.gov ID
- NCT04217460
- Acronym / sponsor ID
- FIST / phowell
- Conditions
- Word Finding Difficulty, Communication Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Children screened for word-finding difficulty. Children at risk are matched with controls who do not have word-finding difficulty. Blind intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention for fluency difficulty (controls) | Active comparator | Behavioral: Intervention for fluency difficultyBehavioural 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) | Experimental | Behavioral: Intervention for fluency difficultyBehavioural intervention (children practice speaking specially constructed non-word materials). Intervention is the same for both arms, here this is for experimental group |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- matched to children with word-finding difficulty by age, gender and native language
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention for fluency difficultyChildren 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. | Behavioural | Intervention for fluency difficulty (controls), Intervention for fluency difficulty (experimental) |
Primary outcome
Non-word Repetition (NWR)
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: Undecided. Pseudoanonymized in parents agree
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention for fluency difficulty in people with Word Finding Difficulty and Communication Disorders, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-word Repetition (NWR) (time frame: 3 weeks intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.