Maximising the impact of speech and language therapy for children with speech sound disorder - Phase 2 England

ISRCTN	ISRCTN90817895
DOI	https://doi.org/10.1186/ISRCTN90817895
Integrated Research Application System (IRAS)	338532
Central Portfolio Management System (CPMS)	60438
National Institute for Health and Care Research (NIHR)	208136
Sponsor	North Bristol NHS Trust
Funder	National Institute for Health and Care Research

Submission date: 09/12/2025
Registration date: 21/01/2026
Last edited: 16/02/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Every year around 50,000 children with speech problems are referred to NHS speech and language therapy. The therapy these children receive varies and we do not yet know what works best. In the preparatory work for this study, we worked with speech and language therapists, young people, parents, and carers to develop a Core Outcome Set. This is an agreed list of things to measure before and after therapy to show what changes have taken place in a child’s speech. It includes the number of sounds that the child uses correctly and parent/carer views on how easy they are to understand. Collecting this data from a large number of children will help us to work out which types of therapy work best for different children. In this study, we are testing the process for collecting data with five NHS sites.

Who can participate?
We will recruit one hundred children and young people who are having speech and language therapy to help with their speech. They will be invited to take part by speech and language therapists at the five participating NHS sites. We will also interview NHS staff, including speech and language therapists, service managers and commissioners.

What does the study involve?
During routine speech and language therapy sessions, therapists will use a new electronic form to fill in information about children’s speech, goals and progress. The therapy that children receive will not change. Speech and language therapists, managers and commissioners will be invited to focus groups and interviews to talk about what might make it difficult for their service to collect the data as well as what would make it easier.

What are the possible benefits and risks of participating?
Participants will help researchers learn how to make speech and language therapy better for children and young people in the future. We do not think there is anything negative about taking part in the project.

Where is the study run from?
The study is being run by researchers at Bristol Speech and Language Therapy Research Unit, Newcastle University and University of Strathclyde (UK)

When is the study starting and how long is it expected to run for?
March 2026 to February 2027

Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Dr Sam Burr, misltoe@nbt.nhs.uk

Contact information

Dr Sam Burr
Scientific

Bristol Speech and Language Therapy Research Unit
North Bristol NHS Trust
Pines and Steps
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

ORCID ID	0000-0002-4177-2459
Phone	+44 (0)117 41 43951
Email	MISLToe@nbt.nhs.uk

Dr Sam Burr
Scientific

Bristol Speech and Language Therapy Research Unit
North Bristol NHS Trust
Pines and Steps
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Dr Caitlin Holme
Scientific

Bristol Speech and Language Therapy Research Unit
North Bristol NHS Trust
Pines and Steps
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Dr Reny Raju
Scientific

Bristol Speech and Language Therapy Research Unit
North Bristol NHS Trust
Pines and Steps
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Study information

Primary study design	Observational
Study design	Observational; Design type: Validation of outcome measures
Secondary study design	Validation of outcome measures
Scientific title	Maximising the Impact of Speech and Language Therapy for children with Speech Sound Disorder Phase 2 (MISLToe_SSD-2): A feasibility study of collection of the Core Outcome Set
Study acronym	MISLToe_SSD-2
Study objectives	Primary objective: To determine the feasibility of collecting COS data with children with speech sound disorder as part of routine NHS Speech and Language Therapy clinical practice. Secondary objectives: 1. Establish the process for COS data collection through SystmOne, an electronic health record system. 2. Identify the barriers and enablers to implementation of COS data collection in SLT services. 3. Determine approaches to mitigation of barriers. 4. Carry out a feasibility study to determine potential for participant recruitment and COS data collection in a full-scale study.
Ethics approval(s)	Approved 17/12/2025, West of Scotland REC 5 (West of Scotland Research Ethics Service Level 2, Administration Building, Gartnavel Royal Hospital, 1055 Great Western Road, Glasgow, G12 0XH, United Kingdom; +44 (0)141 314 0213; ggc.wosrec5@nhs.scot), ref: 25/WS/0194
Health condition(s) or problem(s) studied	Speech sound disorder
Intervention	To achieve our aim of establishing whether data collection for the Core Outcomes Set (COS) is feasible as part of routine clinical practice for NHS speech and language therapy (SLT) services in England, we will do the following: First, in WP1 we will work with speech and language therapists to test, finalise and pilot the collection of the Core Outcome Set data within SystmOne. SystmOne is one of the most widely used electronic patient record systems in the UK. We will test the feasibility of data collection in five NHS sites across England. We will collect feedback on the usability and functionality of the S1 questionnaire from a clinician's perspective (the SLTs). Second, in WP2 we will explore potential barriers and enablers to future large-scale routine data collection across NHS sites. This will involve qualitative data collection from the following participant groups: 1. 3 x focus groups with SLTs from participating sites (month 4, month 8 and month 12) 2. 1 x focus group with SLTs from non-data collecting sites (month 4) 3. Individual interviews with service managers (month 4 and month 13) 4. Individual interviews with people who have commissioning responsibilities (month 9) 5. Parent feedback via questionnaires (ongoing throughout the project) 6. 2 x surveys of UK-based SLTs (including closed and open questions to generate both quantitative and qualitative data) (month 5 and month 13) We will also speak with members of the IT systems teams from each site to examine and determine a response to minimise the potential barriers and maximise enablers to the collection of COS data and the minimum dataset from an organisational and individual perspective. The feedback we gather will inform the design a theory-led training package for clinicians to enable successful implementation of collection of COS data in routine clinical practice. Third, in WP3 we will test the COS data collection in routine clinical care by collecting data with 20 children with SSD from each participating site. We will examine the completeness and accuracy of the data collected. This will enable us to determine the potential for recruitment and data collection in a future large-scale study to collect these data from NHS sites across the UK as part of subsequent Programme Grant for Applied Research (PGfAR) funded MISLToe_SSD Phase 3.
Intervention type	Other
Primary outcome measure(s)	Speech intelligibility measured using the Intelligibility in Context Scale at pre- and post-intervention
Key secondary outcome measure(s)	1. Percentage of consonant sounds produced correctly measured using the Diagnostic Evaluation of Articulation and Phonology (DEAP) pre- and post-intervention 2. Ability to produce phonemes, e.g. in imitation, measured using the DEAP pre- and post-intervention 3. Number of phonemes used measured using the DEAP pre- and post-intervention 4. Percentage of vowel sounds produced correctly measured using the DEAP pre- and post-intervention 5. Percentage of phonemes produced correctly measured using the DEAP pre- and post-intervention 6. Phonological awareness measured using the Newcastle Assessment of Phonological Awareness pre- and post-intervention
Completion date	26/02/2027

Eligibility

Participant type(s)	Carer, Health professional, Patient
Age group	Mixed
Sex	All
Target sample size at registration	535
Key inclusion criteria	WP1 participants: 1. Any qualified Speech and Language Therapist (SLT) employed within one of the participating sites 2. HCPC/RCSLT registered 3. Specialism or special interest in working with children with Speech Sound Disorder (SSD) WP2 participants: 1. SLT focus groups/survey: 2. Qualified clinical SLTs with experience in assessing and providing intervention for children with SSD Service manager interviews: 1. Service managers working in one of the five participating NHS sites Commissioner interviews: 1. People with commissioning responsibilities working in one of the five participating NHS sites Parent questionnaires: 1. Parent/carer of a child who has been diagnosed with SSD 2. Parent/carer of a child who is participating in WP3 WP3 participants: 1. Children aged 2-18 years with SSD of unknown cause (not associated with cleft palate, cerebral palsy or hearing impairment) 2. Known to the NHS SLT service at one of the five participating sites 3. Children who have a legally responsible adult capable of giving consent for the child to participate in the study, or young people who are over the age of 16 years who can consent on their own behalf
Key exclusion criteria	WP1: 1. Non-SLTs WP2: 1. SLT focus groups/survey: 2. Individuals who are not qualified SLTs with clinical experience in assessing and providing intervention for children with SSD Service manager interviews: 1. Individuals who do not work as a service manager 2. Individuals who work as service managers, but not within one of the five participating NHS sites Commissioner interviews: 1. Individuals whose role does not include commissioning responsibilities 2. Individuals who have commissioning responsibilities, but not within one of the five participating NHS sites Parent questionnaires: 1. Parents whose children are not participating in WP3 WP3: 1. Adults (over 18 years) 2. Children with SSD of known cause (e.g., associated with cleft palate, cerebral palsy or hearing impairment) 3. Children who do not have a legally responsible adult capable of giving consent for the child to participate in the study, or where the young person is aged over 16 years the service deems them to lack capacity to consent
Date of first enrolment	02/03/2026
Date of final enrolment	01/02/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Cambridgeshire Community Services NHS Trust

Unit 7-8
Meadow Park
Meadow Lane
St. Ives
PE27 4LG
England

Hertfordshire Community NHS Trust

Unit 1a Howard Court
14 Tewin Road
Welwyn Garden City
AL7 1BW
England

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England

Wirral Community Health and Care NHS Foundation Trust

Derby Road
Birkenhead
CH42 0LQ
England

County Durham and Darlington NHS Foundation Trust

Darlington Memorial Hospital
Hollyhurst Road
Darlington
DL3 6HX
England

North Bristol NHS Trust

Southmead Hospital
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
England

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Editorial Notes

16/02/2026: The date of first enrolment was changed from 02/02/2026 to 02/03/2026.
04/02/2026: Study contacts were added to the record.
09/12/2025: Study's existence confirmed by the NIHR.