Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000279325
Ethics application status
Approved
Date submitted
28/05/2008
Date registered
30/05/2008
Date last updated
16/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A family-centred model of care in paediatric speech pathology: a pilot study
Scientific title
The efficacy of a family-centred model of care in paediatric speech pathology in improving speech and language measures and parent satisfaction, compared to usual speech pathology practice.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
paediatric speech and language disorders 3201 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3364 3364 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Family-centred model of care, speech pathology therapy techniques for speech and language disorders, detailed goal setting with parents, weekly therapy for 14 weeks, home visits by speech pathologist, home practice
Intervention code [1] 2938 0
Rehabilitation
Comparator / control treatment
Usual speech pathology therapy techniques and goal setting for speech and language disorders, weekly therapy for 14 weeks, home practice
Control group
Active

Outcomes
Primary outcome [1] 4250 0
Measure of Processes of Care (MPOC-56)
Timepoint [1] 4250 0
Immediately pre- and post-intervention period
Primary outcome [2] 4251 0
Articulation or phonology assessment of Diagnostic Evaluation of Articulation and Phonology (DEAP) tool
Timepoint [2] 4251 0
Immediately pre- and post-intervention period
Primary outcome [3] 4252 0
Receptive Language Index of Clincal Evaluaiton of Language Fundamentals - Preschool 2 Australian (CELF-P2A) tool
Timepoint [3] 4252 0
Immediately pre- and post-intervention period
Secondary outcome [1] 7181 0
Renfrew Action Picture test
Timepoint [1] 7181 0
Immediately pre- and post-intervention period
Secondary outcome [2] 7182 0
Goal Attainment Scale
Timepoint [2] 7182 0
Immediately pre- and post-intervention period
Secondary outcome [3] 7183 0
Parent satisfaction
Timepoint [3] 7183 0
Immediately pre- and post-intervention period

Eligibility
Key inclusion criteria
Aged between 3.0 and 6.0 years
Speech sound disorder or language disorder
Normal hearing and vision, with or without correction
Minimum age
3 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parent reported neuromuscular, cognitive or untreated behavioural disorders.
Oro-facial/oro-motor abnormality
ymptoms consistent with verbal dyspraxia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be recruited from the Ballarat Health Services speech pathology waiting list by a speech pathologist not involved as a researcher in the study. The randomisation schedule will be prepared by the principal researcher (not a member of the speech pathology department) and allocation will not be revealed until consent obtained and eligibility confirmed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random numbers table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 6098 0
3350

Funding & Sponsors
Funding source category [1] 3434 0
Hospital
Name [1] 3434 0
Ballarat Health Services
Country [1] 3434 0
Australia
Funding source category [2] 256831 0
Charities/Societies/Foundations
Name [2] 256831 0
Speech Pathology Australia
Country [2] 256831 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Bev Phillips
Address
Queen Elizabeth Centre
Ballarat Health Services
102 Ascot Street South
Ballarat VIC 3350
Country
Australia
Secondary sponsor category [1] 3076 0
Hospital
Name [1] 3076 0
Ballarat Health Services
Address [1] 3076 0
PO Box 577
Ballarat VIC 3353
Country [1] 3076 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5458 0
Ballarat Health Services and St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 5458 0
Ballarat Health Services
PO Box 577
Ballarat VIC 3353
Ethics committee country [1] 5458 0
Australia
Date submitted for ethics approval [1] 5458 0
30/05/2008
Approval date [1] 5458 0
Ethics approval number [1] 5458 0
12June08/2.8

Summary
Brief summary
The aim of the research project is to compare a family-centred model of care in paediatric speech pathology with usual paediatric speech pathology practice performed at Ballarat Health Services. The project will also explore parent/carer satisfaction/dissatisfaction with family-centred care.
Hypotheses
1. The family-centred model of care will produce similar speech and language outcomes compared to usual speech pathology practice.
2. Goals (as measured by the Goal Attainment Scale) will be achieved more successfully following a family-centred model of care compared to usual speech pathology practice.
3. Parents will be more satisfied with the family-centred model of care compared to those whose children participate in the usual practice model.
Trial website
Trial related presentations / publications
Speech Pathology Australia Annual Conference May 2010.
Public notes

Contacts
Principal investigator
Name 28625 0
Address 28625 0
Country 28625 0
Phone 28625 0
Fax 28625 0
Email 28625 0
Contact person for public queries
Name 11782 0
Associate Professor Bev Phillips
Address 11782 0
Queen Elizabeth Centre
Ballarat Health Services
102 Ascot Street South
Ballarat VIC 3350
Country 11782 0
Australia
Phone 11782 0
(03) 5320 3994
Fax 11782 0
(03) 5320 3800
Email 11782 0
bevph@bhs.org.au
Contact person for scientific queries
Name 2710 0
Associate Professor Bev Phillips
Address 2710 0
Ballarat Health Services
102 Ascot Street South
Ballarat VIC 3350
Country 2710 0
Australia
Phone 2710 0
(03) 5320 3994
Fax 2710 0
(03) 5320 3800
Email 2710 0
bevph@bhs.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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