NCT04217460

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

3.4 years

First QC Date

December 29, 2019

Last Update Submit

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 COMPARATOR

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

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

Behavioral: Intervention for fluency difficulty

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.

Intervention for fluency difficulty (controls)Intervention for fluency difficulty (experimental)

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

RECRUITING

MeSH Terms

Conditions

AnomiaCommunication Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Language DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

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
Model Details: Children screened for word-finding difficulty. Children at risk are matched with controls who do not have word-finding difficulty. Blind intervention.
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

Locations