Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Yvonne Wren
ORCID ID
http://orcid.org/0000-0002-1575-453X
Contact details
Bristol Speech and Language Therapy Research Unit
Pines and Steps
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)117 414 3951
Yvonne.Wren@bristol.ac.uk
Type
Scientific
Additional contact
Dr Jennifer Chesters
ORCID ID
http://orcid.org/0000-0002-0843-7536
Contact details
North Bristol NHS Trust
Pines and Steps
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
-
Jennifer.Chesters@nbt.nhs.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 276718, CPMS 44784
Study information
Scientific title
Clinical 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
Acronym
ATLAS
Study hypothesis
1. 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
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
Study design
Multi-site prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Screening
Patient information sheet
See additional files for children aged 4-5 years (ISRCTN12718815_PIS_Child4to5yrs_06Nov20_V1), children aged 6-7 (ISRCTN12718815_PIS_Child6to7yrs_06Nov20_V1), parents (ISRCTN12718815_PIS_Parent_06Nov20_V2), and clinicians (ISRCTN12718815_PIS_Clinician_06Nov20_V2) (added 02/12/2020)
Condition
Children with or suspected to have Developmental Language Disorder (DLD)
Intervention
Three 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 type
Other
Phase
Drug names
Primary outcome measure
Language ability will be measured using the Language Explorer subscores and total score at a single timepoint (assessment session)
Secondary outcome measures
1. 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 trial start date
01/11/2020
Overall trial end date
31/10/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. 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
Recruitment start date
16/11/2020
Recruitment end date
31/08/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Children’s Speech and Language Therapy Sirona Care & Health
Eastgate Centre
Eastgate Road
Bristol
BS6 6XX
United Kingdom
Trial participating centre
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
Trial participating centre
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
Organisation
Therapy Box Limited
Sponsor details
Sun Studios
Unit 3
30 Warple Way
London
W3 0RX
United Kingdom
+44 (0)208 7493474
rbright@therapy-box.co.uk
Sponsor type
Industry
Website
Organisation
North Bristol NHS Trust
Sponsor details
Research and Innovation
Level 3
Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)117 4149330
researchsponsor@nbt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. 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 statement
The data-sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/02/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
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