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Table 2 WHO trial items

From: Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate

Data category

Information

Primary registry and trial identifying number

ISRCTN 17441953

Date of registration in primary registry

22 March 2021

Secondary identifying numbers

 

Source(s) of monetary or material support

Chief Scientist Office of Scotland

Primary sponsor

University of Strathclyde

Secondary sponsor(s)

N/A

Contact for public queries

joanne.cleland@strath.ac.uk

Contact for scientific queries

joanne.cleland@strath.ac.uk

Public title

Ultrasound visual biofeedback versus standard treatment for children with cleft lip and palate

Scientific title

SonoSpeech Cleft Pilot: a pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate

Countries of recruitment

Scotland

Health condition(s) or problem(s) studied

Cleft lip and palate

Intervention(s)

Active comparator: ultrasound visual biofeedback

Treatment as usual: articulation intervention

Key inclusion and exclusion criteria

Ages eligible for study: 4 to 16 years

Sexes eligible for study: all

Accepts healthy volunteers: no

Inclusion criteria: speech disorders associated with cleft lip and palate

Exclusion criteria: no spoken English; severe hearing loss; severe learning disability

Study type

Interventional

Allocation: randomized intervention model. Parallel assignment masking: single blind (investigator, outcomes assessor)

Primary purpose: treatment

Phase II

Date of first enrolment

October 2021

Target sample size

40

Recruitment status

Recruiting

Primary outcome(s)

Percentage targeted consonants correct measured using speech assessment as the percentage of treated speech sounds produced correctly in words at baseline, 6 weeks, and 3 months

Key secondary outcomes

1. Patient- and carer-reported speech function and intelligibility for children aged ≥ 8 years measured using the Intelligibility in Context Scale and the CLEFT-Q speech function scale at baseline, 6 weeks, and 3 months 2. Patient- and carer-reported quality of life for children aged ≥ 8 years measured using the CLEFT-Q quality of life scale at baseline, 6 weeks, and 3 months 3. Patient and carer satisfaction with both interventions measured using the Experience of Service Questionnaire at 6 weeks, and 3 months