Maximising the impact of speech and language therapy for children with speech sound disorder

ISRCTN	ISRCTN66763072
DOI	https://doi.org/10.1186/ISRCTN66763072
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	313900
Protocol serial number	IRAS 313900, CPMS 52574
Sponsor	North Bristol NHS Trust
Funder	National Institute for Health Research

Submission date: 30/03/2022
Registration date: 13/06/2022
Last edited: 10/03/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Every year over 70,000 children with speech sound disorders receive different types of speech and language therapy. We don’t know which is most effective. We want to collect information which will help us work out which type works best. This study will enable us to agree what information we should collect.

Many children have difficulties learning to speak and some of these have a speech sound disorder. These children can be difficult to understand or sound different to their friends. If their problems persist, they are less likely to do well in school and may struggle to make friends or get jobs in adulthood.

Who can participate?
This study is open to qualified speech and language therapists working with specialist experience of working with children with speech sound disorder (SSD) in NHS services.

What does the study involve?
We will use information from previous research to work out what information would be helpful to collect. We will run workshops with speech and language therapists and also with young people and parents of children with speech sound disorders to find out what information they think we should collect. A panel of experts will help us to establish a process for collecting information from NHS services. This will mean that information can be compared across NHS services. We will be able to list the different types of therapy and record the amount of progress children make. We will use this information to determine which types are most effective.

What are the possible benefits and risks of participating?
Taking part in this research will help this study to achieve its aim of improving the efficiency and effectiveness of NHS SLT services for children with SSD, and their families.

Your participation in this research can be recorded as a Continuing Professional Development (CPD) activity.

During the conversations with other professionals in the workshop different opinions may be shared, which could make some participants feel uncomfortable. Members of the study team are trained in conflict management and will be able to support the discussions in a way that means everyone can share their views and have open, positive and constructive discussions.

Taking part in this workshop will mean you need to take around 6 hours out of work. This time is compensated to your clinical service by the study. We can also provide funding towards childcare to support you to take part in the workshops.

Where is the study run from?
Bristol Speech and Language Therapy Unit (BSLTRU) (UK)

When is the study starting and how long is it expected to run for?
March 2022 to August 2023

Who is funding the study?
This study is part of a larger project funded by a National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) study (ref NIHR202766) (UK)

Who is the main contact?
Senior Research Associate Dr Sam Burr, sam.burr@nbt.nhs.uk

Contact information

Dr Sam Burr
Scientific

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

ORCID ID	0000-0002-4177-2459
Phone	+44 117 41 43951
Email	sam.burr@nbt.nhs.uk

Study information

Primary study design	Other
Study design	Multicentre qualitative study
Secondary study design
Study type	Participant information sheet
Scientific title	MISLToe_SSD: Maximising the Impact of Speech and Language Therapy services for children with Speech Sound Disorder
Study acronym	MISLToe_SSD
Study objectives	76,000 children with Speech Sound Disorder (SSD) are referred to speech and language therapy (SLT) in the UK every year. Untreated, SSD leads to poor outcomes in education, employment, and mental health. SLT intervention in the UK is delivered via care pathways and these are often resource rather than evidence-driven and there is significant national variation. There is a pressing need to identify which care pathways are most effective and efficient within NHS service constraints to improve outcomes and maximise cost-effectiveness. Before we can determine which care pathways are most effective and efficient, we must establish a Core Outcomes Set (COS) and minimum dataset. The objectives of this develop work are therefore to: 1. Develop a protocol for collection of a COS and minimum dataset for children with SSD; 2. Agree a standard diagnostic process for identifying subtypes of SSD; 3. Determine the range and specification of interventions for SSD in UK NHS SLT services; 4. Identify the process for future health economic analysis.
Ethics approval(s)	This study does not require ethics approval because it involves solely NHS staff as participants.
Health condition(s) or problem(s) studied	Participants will be qualified professional speech and language therapists with specialist knowledge of working with children with speech sound disorders (SSD). They will take part in a virtual workshop to discuss and agree a standard process for assessing and diagnosing speech sound disorder in children. They will agree a list of interventions for SSD and which ones should be used to treat the different sub-types of SSD. Participants will also be invited to complete an online survey and online card sorting activity to agree labels and descriptions for each of the interventions. A further participant activity will involve a modified Delphi study during which a panel of expert SLTs and academics will agree the diagnostic process, interventions and outcomes to form a Core Outcome Set for SSD.
Intervention	Umbrella review of current literature to inform content for the COS and minimum dataset. Participatory workshop with parents and SLTs to agree the diagnostic process for SSD. Expert panel of SLTs and parents to agree a final COS and minimum dataset.
Intervention type	Other
Primary outcome measure(s)	A comprehensive list of speech sound assessments and interventions, used with children between x and Y, at any point in their treatment pathway. This will be elicited through discussion with the focus group members, and supplemented through a list compiled by the research team through a prior umbrella review. These outcomes and assessments will then be reviewed using a nominal-group/Delphi technique to understand which of the assessments and interventions are most commonly used in practice.
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	28/02/2024

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	All
Target sample size at registration	5
Total final enrolment	6
Key inclusion criteria	1. Any gender, age, ethnicity or socio economic grouping. 2. Any qualified SLT 3. HCPC/RCSLT registered 4. Specialism or special interest in working with children with SSD
Key exclusion criteria	Unqualified or unregistered SLTs (HCPC/RCSLT). SLT with no experience of working with children with SSD.
Date of first enrolment	01/06/2022
Date of final enrolment	01/10/2022

Locations

Countries of recruitment

United Kingdom
England
Scotland

Study participating centres

Northumbria Healthcare NHS Foundation Trust

Speech and Language Therapy
Albion Road Resource Centre
North Shields
NE29 0HG
United Kingdom

Solent NHS Trust

Solent NHS Trust Headquarters
Highpoint Venue
Bursledon Road
Southampton
SO19 8BR
United Kingdom

Northern Lincolnshire and Goole NHS Foundation Trust

Diana Princess of Wales Hospital
Scartho Road
Grimsby
DN33 2BA
United Kingdom

Sirona Care & Health

2nd Floor Kingswood Civic Centre, High Street, Kingswood
Bristol
BS15 9TR
United Kingdom

NHS Lothian

Waverley Gate
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to participant confidentiality.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		29/04/2024	10/03/2025	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/03/2025: Publication reference added.
21/02/2024: The contact confirmed the record is up to date.
09/08/2023: The following changes were made to the trial record:
1. The overall end date was changed from 28/08/2023 to 28/02/2024.
2. The total final enrolment was added.
18/10/2022: The total final enrolment was added.
04/07/2022: Internal review.
03/05/2022: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).