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Trial registered on ANZCTR


Registration number
ACTRN12611001039976
Ethics application status
Approved
Date submitted
30/09/2011
Date registered
4/10/2011
Date last updated
19/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Group, individual and home based speech pathology interventions for three and four year olds
Scientific title
Comparative analysis of parent perceptions of the efficacy of group, individual and home based speech pathology interventions for three and four year olds
Secondary ID [1] 273147 0
None
Universal Trial Number (UTN)
U1111 1124 4236
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
speech and language delays and disorders 270892 0
Condition category
Condition code
Physical Medicine / Rehabilitation 279067 279067 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each treatment arm will form it's own control group as prior to the intervention period there will be an 8 week period of no intervention. Each group acts as it's own control in crossover but the three different treatments are run in parallel. Each participant receives only one type of treatment during the course of the study.

All arms will involve an 8 week intervention period with group and individual treatment arms having weekly therapy sessions of one hour duration. The home based treatment arm will have an initial one hour session to explain and demonstrate how to implement the program and then a phone review consultation at the midpoint (week 4) of their intervention period to monitor their progress and to update their program if required. All treatment arms have access to phone consultation with the treating speech pathologist on request throughout the intervention period.


Arm 1: Group therapy for speech and language using eclectic therapy approach utilising current standard clinical practice by an experienced speech pathologist and home practice with parent.

Arm 2: Individual therapy for speech and language using eclectic therapy approach utilising current standard clinical practice by an experienced speech pathologist and home practice with parent

Arm 3: Home based therapy for for speech and language using eclectic therapy approach utilising current standard clinical practice with parent under the supervision of an experienced speech pathologist

For speech delays/disorders the eclectic therapy approach involves application of phological based therapies including metaphon approach, cycles, multiple oppositions, maximal and minimal pairs therapy integrated with phonological awareness therapy as well as traditional articulation therapy heirarchies. For language delays/disorders the therapy will include language stimulation training for parents in the use of strategies such as modelling, recasting as well as expansion and direct practice of specific language skills and forms such as understanding spcific concepts, use of Subject Verb Object sentence structure, use of Wh question forms, use of adjectives and use of specific tense markers and pronouns.

All therapy approaches involve the speech pathologist and/or parent playing games with the child and encouraging them to attempt new ways of producing speech sounds or to attempt specific language skills and providing verbal feedback on their productions/attempts.
Intervention code [1] 269479 0
Treatment: Other
Intervention code [2] 269485 0
Rehabilitation
Comparator / control treatment
No treatment period preceeding intervention period for all participants in all treatment arms will provide participant matched control period of 8 weeks. Patient acts as own control (cross over study) for contrasting each therapy individually to a no intervention control group.

The three therapies will be contrasted to each other to determine relative efficacy as the dependent variable is actually the service delivery modality as all treatment arms involve the use of the same therapy approaches by the same treating clinician.

A comparison of one of the control groups to all three treatment arms will be conducted utilising the group whose demographic data is most representative of the entire sample (i.e. may be Arm 1, 2 or 3) based on age, gender and highest level of parental education.
Control group
Active

Outcomes
Primary outcome [1] 279717 0
Parent perceptions as reported on a survey using a Likert scale of 1-10 of their concern about their child's communication, knowledge of how to help their child's communication and confidence in helping their child with their communication.
Timepoint [1] 279717 0
Baseline prior to no treatment period
Midpoint (8 weeks after baseline and prior to commencing intervention)
Post-intervention (after 8 weeks of intervention)
Primary outcome [2] 279722 0
Parent perceptions as reported on a survey using a Likert scale of 1-10 of their child'e ability to: use words to say what he/she wants and needs; join words together the same as other children his/her age; understand what people say; speak clearly and say words correctly; use appropriate social skills and behave well
Timepoint [2] 279722 0
Baseline prior to no treatment period
Midpoint (8 weeks after baseline and prior to commencing intervention)
Post-intervention (after 8 weeks of intervention)
Secondary outcome [1] 294285 0
Assessment results on the following speech and language tests:
Peabody Picture Vocabulary Test - 4th Edition
Expressive Vocabulary Test - 2nd Edition
Golman-Fristoe Test of Articulation - 2nd Edition
Preschool Inventory of Phonological Awareness (if clinically indicated)
Timepoint [1] 294285 0
Baseline prior to no treatment period
Midpoint (8 weeks after baseline and prior to commencing intervention)
Post-intervention (after 8 weeks of intervention)
Secondary outcome [2] 294286 0
A spontaneous speech sample to be analysed for speech and language ability. The sample will be obtained by audio recording of spontaneous conversation by the child during play with their parent or carer. The sample will be transcribed and then analysed using the SALT-NZ software (research version see http://www.saltsoftware.com/salt/nzresearch/ for further details) as well as the audio file analysed and rated by an independent speech pathologist for speech intelligibility.
Timepoint [2] 294286 0
Baseline prior to no treatment period
Midpoint (8 weeks after baseline and prior to commencing intervention)
Post-intervention (after 8 weeks of intervention)

Eligibility
Key inclusion criteria
Aged 3 years 0 months to 4 years 11 months at start of participation in study.
Must have some speech and or language difficulties.

All participants will have had a prior consulation with an allied health professional, child health nurse or medical practitioner for referral purposes and to check general health as this is part of existing service intake requirements.
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
English is not the child’s first language
Previous speech pathology interventions
Currently seeing a Physiotherapist or Occupational Therapist
Known intellectual impairment
Diagnosis of Autistic Spectrum Disorders
Permanent hearing impairment
Uncorrected visual impairments

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)
After a participant consents to participate they are then randomly assigned a treatment modality by the randomisation list holder (not otherwise associated with the research project) using computer generated randomised list. The list holder then records and informs the treating clinician which treatment modality the participant is assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence generation of numbers 1-3 for allocation to to the 3 treatment arms.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Both crossover and parallel - each group acts as own control in crossover but 3 different treatments are run in parallel. Each participant receives only one treatment during the course of the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
99
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269956 0
Charities/Societies/Foundations
Name [1] 269956 0
Toowoomba Hospital Foundation and Pure Land Learning College
Country [1] 269956 0
Australia
Primary sponsor type
Hospital
Name
Darling Downs Health Service District
Address
Toowoomba Hospital
Pechey Street
PMB 2
Toowoomba QLD 4350
Country
Australia
Secondary sponsor category [1] 268952 0
University
Name [1] 268952 0
The University of Queensland
Address [1] 268952 0
School of Health and Rehabilitation Sciences
St Lucia Queensland 4072
Country [1] 268952 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271925 0
Darling Downs Health Service District Human Research Ethics Committee
Ethics committee address [1] 271925 0
Ethics committee country [1] 271925 0
Australia
Date submitted for ethics approval [1] 271925 0
Approval date [1] 271925 0
27/07/2011
Ethics approval number [1] 271925 0
HREC/11/QTDD/9

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33220 0
Address 33220 0
Country 33220 0
Phone 33220 0
Fax 33220 0
Email 33220 0
Contact person for public queries
Name 16467 0
Rachel Tosh
Address 16467 0
Toowoomba Hospital
Speech Pathology
PMB 2
Toowoomba QLD 4350
Country 16467 0
Australia
Phone 16467 0
+617 46166000
Fax 16467 0
+617 46165699
Email 16467 0
[email protected]
Contact person for scientific queries
Name 7395 0
Rachel Tosh
Address 7395 0
Toowoomba Hospital
Speech Pathology
PMB 2
Toowoomba QLD 4350
Country 7395 0
Australia
Phone 7395 0
+617 46166000
Fax 7395 0
+617 46165699
Email 7395 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
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