Intervention for Fluency Difficulty (FIST)

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.

Study Overview

• Status: Recruiting
• Conditions: Communication Disorders; Word Finding Difficulty
• Intervention / Treatment: Behavioral: Intervention for fluency difficulty

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, WC1H0AP
    • Recruiting
    • Peter Howell
    • Contact: Peter Howell, PhD; Phone Number: +4402076797566 +4402076797566; Email: p.howell@ucl.ac.uk
    • Contact: Roa'a AlSulaiman; Phone Number: +4402076797566 +4402076797566; Email: roaa.al-sulaiman.17@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Behavioral: 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.
EXPERIMENTAL: 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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 24, 2018
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: December 29, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (ACTUAL): January 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 2, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Anomia; Communication Disorders
• Other Study ID Numbers: phowell

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Pseudoanonymized in parents agree

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No