An investigation as to which speech samples lead to the most reliable listener judgements when assessing speech in 3-year-old children with cleft palate with or without a cleft lip

Plain English summary of protocol

Background and study aims
A cleft is a gap or split in the upper lip and/or roof of the mouth (palate) that is present from birth. This research aims to develop an assessment framework to assess speech in three-year-old children with cleft palate. To develop the assessment framework the researchers need to find out the following information:
1. Which speech samples (the type of speech produced e.g. single words in picture naming, repeating sentences, playing with and talking about toys) are most easily completed by 3-year-olds with a cleft palate?
2. How do different speech samples, and rating scales impact upon speech ratings made by Cleft Speech and Language Therapists?
3. Which speech samples and rating scales do Cleft Speech and Language Therapists find easiest or the most appropriate to use?
The researchers will then use the information they have collected to put forward a new assessment framework.
In the UK one of the key times that Speech and Language Therapists see children with cleft palate with or without a cleft lip for an assessment is when they are 3 years old. This is an important assessment time as they can pick up on any problems with their speech and arrange for them to have any extra help if they need it before they start school. However, at the moment there is no agreed format on how best to assess speech at this age. If an assessment framework was developed this could be used at different cleft centres across the UK. This may allow Speech and Language Therapists to compare how patients are doing and track their progress between ages 3 and 5.

Who can participate?
1. 3-year-old children with cleft palate with or without a cleft lip
2. 3-year-old healthy volunteers
3. Speech and Language Therapists who specialise in the area of cleft palate with or without a cleft lip

What does the study involve?
Children taking part in the study will be seen by a Cleft Speech and Language Therapist working at the designated cleft unit. In children with cleft palate with or without a cleft lip, this will be when they attend their usual Speech and Language Therapy appointment at age 3. Children taking part in the study will complete different assessment activities e.g. naming pictures, repeating short phrases, playing with toys. This is similar to the usual assessment activities at age 3 but children will be asked to complete more than one activity. As part of the study, all the assessments will be video recorded.
The study assessment may take longer than an hour. Usually, a 3-year assessment takes 30-60 minutes. Children taking part in the study can take breaks during the assessment if they need to. After the appointment, a report will be provided from the Cleft Speech and Language Therapist.
The recording will be checked to make sure that the sound and video are of high quality. Cleft Speech and Language Therapists will watch the video and analyse the children’s speech.

What are the possible benefits and risks of participating?
Children will receive their speech assessment at 3 years of age as usual (this would be the case if they didn’t participate in the study). Children and their families may be helping the researchers to improve speech assessments for children affected by cleft palate in the future. Although the assessment should take no longer than an hour (excluding any breaks the child might want to take) the assessment may take slightly longer than the usual 3-year assessment.
There are no anticipated disadvantages to healthy volunteers participating in the study. Children and their parent/guardian will need to travel to Birmingham Children’s Hospital and to stay for the assessment session; this will take up some of their time. Children participating in the study will receive a speech assessment which they may not have had otherwise. A short report about the child’s assessment will be provided after the appointment. In the unlikely event that the Speech and Language Therapist has any concerns about a child’s speech, parents/guardians will be asked to give consent to refer their child to community Speech and Language Therapy services.
Speech and Language Therapists participating in the study will be contributing to the development of cleft speech assessments at age 3 years.
Participating in the study will take some time either work time or personal time.

Where is the study run from?
The West Midlands Cleft Lip and Palate Service, based at Birmingham Children’s Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2017 to October 2022

Who is funding the study?
1. Coventry University (UK)
2. Investigator initiated and funded

Who is the main contact?
Elizabeth Fitzpatrick
beth.fitzpatrick@nhs.net

Contact information

Miss Beth Fitzpatrick
Public

Speech and Language Therapy Department
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom

ORCID ID	0000-0003-2072-4156
Phone	+44 (0)121 333 9382
Email	beth.fitzpatrick@nhs.net

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

Coventry University
University/education

Associate Pro Vice Chancellor (Research)
Alan Berry Building
1 Priory Street
Coventry
CV1 5FB
England
United Kingdom

Phone	+44 (0)2477659732
Email	iras-sponsor@coventry.ac.uk
Website	http://www.coventry.ac.uk/
"ROR"	https://ror.org/01tgmhj36

Funders

Funder type

University/education

Results and Publications

Study outputs

Editorial Notes

02/11/2023: The intention to publish date was changed from 01/10/2023 to 01/10/2024.
12/02/2021: Trial's existence confirmed by the HRA and Health and Care Research Wales (HCRW).