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

Not Applicable

Completed

• Conditions: Cleft palate +/- cleft lip; Genetic Diseases; Cleft lip and cleft palate

• Registration Number: ISRCTN99721707
• Lead Sponsor: Coventry University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-22
• Study Completion: 2022-10-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Children with a diagnosis of cleft palate +/- cleft lip
2. Aged between 36-47 months
3. Treated at a specific Cleft Unit in the UK
4. Children eligible for a speech assessment at age 36-47 months

Healthy volunteers:
1. Children aged 36-47 months at the time of assessment
2. No current or previous involvement with Speech and Language Therapy, nor are waiting for a Speech and Language Therapy initial assessment
3. No medical condition(s) associated with communication impairments
4. Parent(s)/guardian(s) do not have any concerns about their child’s communication
5. Research Team do not have any concerns about the child’s communication

Speech and Language Therapists (SLTs):
1. The individual is currently working as an SLT
2. The SLT has designated sessions working with paediatric Cleft Patients in an NHS Cleft Centre
3. SLT has completed CAPS-A training and has participated in consensus listening in the audit assessment of children at five years of age

Exclusion Criteria

Individuals with cleft palate +/- cleft lip:
1. Individuals with Submucous Cleft Palate (SMCP)
2. Individuals with an identified genetic syndrome
3. Individuals from a non-English speaking family
4. Failure/technical problem with the recording of the speech assessment

Control group:
1. Failure/technical problem with the recording of the speech assessment
2. Children from a non-English speaking family

Speech and language therapists:
1. The SLT has carried out the study assessment with either a Cleft or Control Group Participant or has carried out a speech assessment with the Cleft Group Participant in the last year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
istener reliability ratings for both speech samples using both ordinal and visual analogue scales (VAS) following the collection of the speech sample data: listening session 1 (ordinal), listening session 2, minimum 4 weeks later (ordinal), listening session 3, minimum 4 weeks later (ordinal and VAS)

Secondary Outcome Measures

Name	Time	Method
1. The acceptability of the speech samples as judged by Specialist Speech and Language Therapists following the completion of all of the listening sessions<br>2. Completion rates of the speech samples by 3-year-old participants calculated in statistical analysis following the completion of all of the listening sessions