ISRCTN ISRCTN12718815
DOI https://doi.org/10.1186/ISRCTN12718815
IRAS number 276718
Secondary identifying numbers IRAS 276718, CPMS 44784
Submission date
12/11/2020
Registration date
23/11/2020
Last edited
13/01/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Ten percent of children have delayed language in the preschool years. Some make progress without help; others need advice from a health visitor or a speech and language therapist (SLT). If a child’s problems with language development continue, they may be diagnosed with Developmental Language Disorder, which can affect their learning and development.
A technology company called Therapy Box has developed an app called Language Explorer. The aim of this app is to help SLTs analyse children’s language abilities. It is hoped that it will support SLTs to make timely decisions about which children need therapy and what the focus of therapy should be, as well as which children may need advice and monitoring only. The Language Explorer app could save money in the NHS by reducing the time needed to carry out language assessment and potentially ensure more children receive the help they need.
The app requires children to listen to a story told with pictures via the app, and then re-tell the story in their own words. This will provide an example of their language which is recorded and analysed by the app to provide a report on the child’s language skills. The children will also be asked questions about the story and to repeat ten sentences.
The aim of this study is to trial the app with children who have problems with their language development to see whether the Language Explorer app can be used to assess their language skills accurately. The researchers will also be asking parents and speech and language therapists about their views and experiences of using Language Explorer.

Who can participate?
Children aged between 4 years and 7 years 11 months old who have a developmental language disorder, and their parents

What does the study involve?
Children aged 6 years and 0 months to 7 years and 11 months will be invited to attend a remote appointment session with their parents. Children aged 4 years and 0 months to 5 years and 11 months will be invited to attend a face-to-face appointment in a clinical setting with their parents. All children will be asked to complete the Language Explorer app and additional language assessments. The researchers will also ask parents if they are happy to be interviewed about their child’s experiences using the app. Once the software has been evaluated, it is hoped that the app can be used in NHS services across the country.

What are the possible benefits and risks of participating?
While there are no benefits to the participant, the study will provide information on how children perform on the Language Explorer app and participants' views and experiences of using the app. This information will help complete the development of the app which in turn may give speech and language therapists more time to work with more children and to reduce waiting times.
It is believed that there are no risks to the participant. However, in the unlikely event that something does go wrong and the participant is harmed during the research study there are no special compensation arrangements. If the participant is harmed and this is due to someone’s negligence then the participant may have grounds for legal action for compensation against North Bristol NHS Trust but the participant may have to pay participants' legal costs. The normal National Health Service complaints mechanisms will still be available to the participant.

Where is the study run from?
The study is being run and co-ordinated by the Bristol Speech and Language Therapy Research Unit (UK)

When is the study starting and how long is it expected to run for?
November 2020 to October 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Yvonne Wren, Yvonne.Wren@bristol.ac.uk

Study website

Contact information

Dr Yvonne Wren
Scientific

Bristol Speech and Language Therapy Research Unit
Pines and Steps
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

ORCiD logoORCID ID 0000-0002-1575-453X
Phone +44 (0)117 414 3951
Email Yvonne.Wren@bristol.ac.uk

Study information

Study designMulti-site prospective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Other
Study typeScreening
Participant information sheet ISRCTN12718815_PIS_Clinician_06Nov20_V2.pdf
Scientific titleClinical evaluation of an automated language transcription and analysis app to assist speech and language therapists with clinical decision making in the evaluation of developmental language disorders
Study acronymATLAS
Study objectives1. Does Language Explorer distinguish children with Developmental Language Disorder (DLD) from children who have typically developing language skills?
2. Does the Language Explorer identify patterns of performance which distinguish groups of children with DLD?
3. What are clinicians’ (speech and language therapists) and parents/carers’ views of Language Explorer?
Ethics approval(s)Approved 11/11/2020, North of Scotland Research Ethics Committee 1, (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; nosres@nhs.net), ref: 20/NS/0128
Health condition(s) or problem(s) studiedChildren with or suspected to have Developmental Language Disorder (DLD)
InterventionThree types of participants will be enrolled in the trial:
1. Children with confirmed or suspected DLD
2. The parents/carers of these children
3. The SLTs carrying out the Language Explorer assessments

Following enrolment into the study, the child will attend for a single assessment session held either remotely or in an SLT clinic, lasting 20 minutes to 1 hour. Children aged 6 years and 0 months to 7 years and 11 months will attend a remote appointment session at home with their parent/carer, facilitated by the local SLT in the clinic. In this session, the child will be asked to complete the Language Explorer App, and the CELF-5 UK assessment, with support from a parent/carer to access these resources on a tablet device. Children aged 4 years and 0 months to 5 years and 11 months will attend a face to face appointment in a clinical setting with their parent/carer. In this session, the local SLT will support the child to complete the Language Explorer App, and the CELF- Preschool 2 UK assessment.

Parents and carers who consent to be interviewed will complete a session by telephone on a separate occasion within 1 month following their child’s appointment. The session will take 20 to 30 minutes and will involve an interview about their child’s experiences using the Language Explorer app.

The SLTs facilitating the Language Explorer assessment sessions will be enrolled as study participants, as the researchers will collect interview data about their experience of using the Language Explorer app. Immediately following the assessment session, a member of the research team will complete the telephone interview with the participating SLT, which will take 20 to 30 minutes.

Four types of data will be collected and analysed:
1. Language Explorer transcription and analysis scores
2. Clinical Evaluation of Language Fundamentals (specifically CELF- Preschool 2 UK and CELF-5 UK) assessment forms and subtest scores
3. SLT Clinical Judgement Form
4. Parent and SLT interview

All children recruited to the study will be assessed on the Language Explorer app. All children will also have the SLT Clinical Judgement Form completed for them. Where the appointment happens remotely, the child will be assessed on the Q-Interactive version of the Clinical Evaluation of Language Fundamentals(CELF-5). Where it takes places in person in a clinical setting, the child will also be assessed on the Clinical Evaluation of Language Fundamentals (CELF-Preschool 2 UK).
Intervention typeOther
Primary outcome measureLanguage ability will be measured using the Language Explorer subscores and total score at a single timepoint (assessment session)
Secondary outcome measures1. For children aged 4 years and 0 months to 5 years and 11 months, language ability will be measured by CELF-preschool 2 UK word structure and recalling sentences subtests at a single timepoint (assessment session)
2. For children aged 6 years and 0 months to 7 years and 11 months, language ability will be measured by CELF-5 UK Word Structure, Recalling Sentences, Formulated Sentences, and Understanding Spoken Paragraphs subtests at a single timepoint (assessment session)
3. Areas of language impairment will be identified via the clinical judgement form using Catalise consortium categories, completed by an SLT at a single timepoint
4. Clinician and parent views of the Language Explorer app will be measured by deriving themes from semi-structured interviews completed within 1 month of the Language Explorer assessment session
Overall study start date01/11/2020
Completion date31/10/2021

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit7 Years
SexBoth
Target number of participants60
Total final enrolment15
Key inclusion criteria1. Children aged between 4 and 7 years inclusive
2. Children who speak and are exposed to only English in the home
3. Children who have been identified by a speech and language therapist as having DLD
4. Case histories that are unremarkable in terms of birth, overall development and general health
Key exclusion criteria1. Children with history of significant hearing problems (e.g. sensori-neural hearing loss or use of hearing aids in the case of severe and recurrent otitis media)
2. Evidence of structural or neurological disorders (e.g. cleft palate, cerebral palsy, autism)
3. Children with significant speech difficulties which impact their intelligibility
4. Children who have been assessed using one of the Clinical Evaluation of Language Fundamentals (CELF) tools in the previous 6 months
Date of first enrolment16/11/2020
Date of final enrolment31/08/2021

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Children’s Speech and Language Therapy Sirona Care & Health
Eastgate Centre
Eastgate Road
Bristol
BS6 6XX
United Kingdom
Children’s Integrated Speech and Language Therapy Service for Hackney and the City
Homerton University Hospital NHS Foundation Trust & Hackney Learning Trust
London
E9 6SR
United Kingdom
Paediatric Speech and Language Therapy
Newcastle upon Tyne NHS Foundation Trust
Level 3, Regent Point
Regent Farm Rd
Newcastle upon Tyne
NE3 3HD
United Kingdom

Sponsor information

Therapy Box Limited
Industry

Sun Studios
Unit 3
30 Warple Way
London
W3 0RX
United Kingdom

Phone +44 (0)208 7493474
Email rbright@therapy-box.co.uk
Website https://therapy-box.co.uk/
North Bristol NHS Trust
Hospital/treatment centre

Research and Innovation
Level 3, Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
England
United Kingdom

Phone +44 (0)117 4149330
Email researchsponsor@nbt.nhs.uk
Website https://www.nbt.nhs.uk/research-innovation
ROR logo "ROR" https://ror.org/036x6gt55

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/02/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination plan1. Submitting abstracts for verbal and poster presentations at conferences such as RCSLT conference, DLD Clinical Excellence Networks
2. Submitting research papers to journals such as International Journal of Language and Communication Disorders, Child Language and Teaching Therapy
3. Through the Bristol Speech and Language Therapy Research Unit newsletter
4. Emailing the clinical teams of the three research sites (Bristol, Newcastle, Hackney) through their service leads
5. Planned publication in high-impact peer-review journals
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V2 06/11/2020 02/12/2020 No Yes
Participant information sheet version V2 06/11/2020 02/12/2020 No Yes
Participant information sheet version V1 06/11/2020 02/12/2020 No Yes
Participant information sheet version V1 06/11/2020 02/12/2020 No Yes
Protocol file version V2 06/11/2020 02/12/2020 No No
Basic results 13/01/2023 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN12718815_PIS_Child4to5yrs_06Nov20_V1.pdf
Uploaded 02/12/2020
ISRCTN12718815_PIS_Child6to7yrs_06Nov20_V1.pdf
Uploaded 02/12/2020
ISRCTN12718815_PIS_Parent_06Nov20_V2.pdf
Uploaded 02/12/2020
ISRCTN12718815_PIS_Clinician_06Nov20_V2.pdf
Uploaded 02/12/2020
ISRCTN12718815_PROTOCOL_06Nov20_V2.pdf
Uploaded 02/12/2020
ISRCTN12718815_BasicResults.pdf

Editorial Notes

13/01/2023: Basic results summary uploaded.
06/12/2022: A scientific contact was removed.
09/09/2022: The final enrolment number has been added.
02/12/2020: The following changes have been made:
1. Uploaded protocol version 2.0, 6 November 2020 (not peer reviewed).
2. The participant information sheet has been uploaded as an additional file.
17/11/2020: Trial's existence confirmed by North of Scotland Research Ethics Committee 1.