Intervention for Fluency Difficulty

NCT ID: NCT04217460

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-24

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Word Finding Difficulty Communication Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Children screened for word-finding difficulty. Children at risk are matched with controls who do not have word-finding difficulty. Blind intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
All details pseudo-anonymized before analysis.

Study Groups

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Intervention for fluency difficulty (controls)

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

Group Type ACTIVE_COMPARATOR

Intervention for fluency difficulty

Intervention Type BEHAVIORAL

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.

Intervention for fluency difficulty (experimental)

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

Group Type EXPERIMENTAL

Intervention for fluency difficulty

Intervention Type BEHAVIORAL

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.

Interventions

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Intervention for fluency difficulty

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Peter Howell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peter Howell

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Peter Howell, PhD

Role: primary

+4402076797566 ext. +4402076797566

Roa'a AlSulaiman

Role: backup

+4402076797566 ext. +4402076797566

Other Identifiers

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phowell

Identifier Type: -

Identifier Source: org_study_id

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