In children with cleft palate speech disorder, is speech improved when trained and supported parents deliver the therapy compared with typical care?

Not Applicable

Completed

• Conditions: Articulation difficulties in children born with cleft palate/velopharyngeal dysfunction; Signs and Symptoms

• Registration Number: ISRCTN10540035
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary

2020 Results article in https://doi.org/10.1111/1460-6984.12542 results (added 20/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-05-01
• Study Start: 2019-12-12
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

For children:
1. Aged between 3 and 6.5 years
2. Presenting with cleft palate with or without cleft lip at birth or velopharyngeal dysfunction, with or without a syndrome not associated with learning disability, with or without suspected velopharyngeal insufficiency
3. Presenting with at least one cleft speech characteristic, with or without developmental speech errors
4. Stimulable for at least one novel consonant
5. Has age-appropriate attention and listening skills, behaviour and receptive and expressive language levels
6. Fluent in English

For parents:
7. Fluent in English,
8. No diagnosed learning disability or mental health issues
9. Able to commit the time to undertake the intervention for 12 weeks

Exclusion Criteria

For children:
1. Has a syndrome with an associated learning disability
2. Has a known neurological deficit
3. Has behavioral problems
4. Has a bilateral hearing loss of greater than 30 decibels
5. Has a symptomatic fistula judged to affect articulation
6. Velopharyngeal surgery planned within the following 4 months
7. Presenting only with lateralisation/palatalisation or double articulation, or has no intra-oral air pressure on pressure consonants

For parents:
8. Known learning disability or mental health issues
9. Unable to make the time commitment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent of speech sound disorder assessed using Percent Consonant Correct - Revised scores. Single word naming, sentence repetition, sound stimulability and spontaneous speech were video recorded on five occasions: at baseline, immediately pre-intervention, midway through the intervention, immediately post-intervention and 2 months post-intervention. Consonants produced with correct place, manner and voice but with accompanying nasal emission/turbulence, dental/interdental, and weak/nasalized realizations were categorised as correct. PCC was calculated by the number of targets elicited divided by the number of targets correct, multiplied by 100. The targets analysed included a single target for each English consonant in word-initial and word-final position, except /h/ and /? /, and the plosives, fricatives and affricates in word-initial and word-final position in the phrase/sentence samples. Two independent therapists, blinded to the treatment arm, completed the analysis.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Intelligibility of speech assessed using the Intelligibility in Context Scale (ICS) questionnaire at baseline and immediately after the end of the intervention<br> 2. Real-world communication ability assessed using the Focus on Communication Outcomes for under Six (FOCUS) scale completed by the parent-trained group on day 1 of training and by the parents in the control group on day 1 of therapy and by all parents immediately after the end of the intervention<br>