Speech intervention for preschoolers with cleft palate using principles of motor learning

• Register: ANZCTR
• Last refreshed on: 10 March 2020
• Main ID: ACTRN12616001446459
• Date of registration: 17/10/2016
• Prospective Registration: Yes
• Primary sponsor: The University of Sydney
• Public title: Speech intervention for preschoolers with cleft palate using principles of motor learning
• Scientific title: Speech intervention for preschoolers with cleft palate using principles of motor learning
• Date of first enrolment: 26/05/2017
• Target sample size: 8
• Recruitment status: Active, not recruiting
• URL: https://anzctr.org.au/ACTRN12616001446459.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Alison Purcell

• Name: Ms Leah Hanley

Key inclusion & exclusion criteria

Inclusion criteria: 1. Non-syndromic cleft palate which has been surgically repaired
2. Evidence of at least two cleft type speech and/or resonance errors on speech pathology assessment (at least 1 passive error and at least 1 active error)
3. 3-6 years of age
4. Age appropriate comprehension skills as measured with the Preschool Language Scales – Fifth Edition (PLS-5)
5. No sensorineural hearing loss
6. English spoken at home
7. No other medically diagnosed developmental disability
Exclusion criteria: Presence of speech errors in a child that has a cleft palate that are not able to be classified as cleft type speech errors on assessment by a speech pathologist

Age minimum: 3 Years
Age maximum: 6 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Physical Medicine / Rehabilitation - Speech therapy

cleft palate;speech disorder;
cleft palate
speech disorder

Intervention(s)

This is an initial study to apply speech intervention using the principles of motor learning to active and passive cleft type speech errors in preschool children aged 3-6 years. It is an alternating treatment single subject design with multiple baselines across participants and behaviours over two treatment phases.
Two treatment phases, phase I and phase II, will be conducted twice weekly for eight weeks. A 4 week maintenance phase will follow each treatment phase. A final assessment will be administered 4 weeks after the final treatment session in phase II. The total study duration will be 28 weeks.
The pre/post-treatment assessment and treatment in the study will be conducted by Certified Practising Speech Pathologists experienced in working with young children. Treatment sessions will go for 45-60 minutes. Each participant will be treated by the same speech pathologist throughout. There is no requirement for any practice outside of the twice-weekly speech therapy sessions.
Parents/carers will attend all the sessions with the participant.
Pre and post assessments and treatment will be conducted in the speech therapy clinic at: Sydney Children’s Hospital, Randwick or Communication Disorders Treatment and Research Clinic (CDTRC), The University of Sydney or the Canberra Hospital.
Therapy speech targets
A set of individualised speech targets will be selected for each participant in the study. Targets will be based on the speech sound errors identified during pre-treatment assessment using the results from the standardised assessment and the cleft speech assessment. A set of 3-6 treatment words that correspond with each selected target will be chosen as treatment items. These treatment items will be presented on picture cards that are age appropriate and

Primary Outcome(s)

Percentage of control words (similar but untreated words) produced correctly[Control probe, at beginning of treatment sessions 3, 6, 9, 12, and 15]

Percentage of treatment items produced correctly in treatment sessions[each treatment session]

Percentage consonants correct on standardised speech assessment (the standardised speech assessment to be used is the Diagnostic Evaluation of Articulation and Phonology (DEAP) articulation and phonology subtests)[in first baseline session and at the post treatment assessment 4 weeks after completion of treatment]

Secondary Outcome(s)

Acceptability measure by blinded listener (a Certified Practising Speech Pathologist) based on connected speech sample using the Universal Parameters for Reporting Speech Outcomes for Individuals with Cleft Palate (Sweeney, Trost-Cardamone, & Whitehill, 2008)[Connected speech sample collected at during baseline and at the post treatment assessment 4 weeks after completion of treatment]

Intelligibility measure by parents using the Intelligibility in Context Scale (ICS)[during first baseline session and at the post treatment assessment 4 weeks after completion of treatment]

Intelligibility measure by blinded listener (a Certified Practising Speech Pathologist) based on connected speech sample using the Universal Parameters for Reporting Speech Outcomes for Individuals with Cleft Palate (Sweeney, Trost-Cardamone, & Whitehill, 2008)[Connected speech sample collected during baseline and at the post treatment assessment 4 weeks after completion of treatment]

Presence of cleft-type errors on cleft specific speech assessment, the Great Ormond Street Speech Assessment (GOS.SP.ASS ’98) (Sell, Harding, & Grunwell, 1999)[in first baseline session and at the post treatment assessment 4 weeks after completion of treatment]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Leah Hanley - Postgraduate student project

Ethics review

Status: Approved
Approval date: 20/09/2016
Contact:

Sydney Children’s Hospitals Network Human Research Ethics Committee

Results

• Date Posted: 15/03/2019