Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001108707
Ethics application status
Approved
Date submitted
29/08/2013
Date registered
3/10/2013
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to measure the efficacy of a manualised oral narrative intervention programme for school-age children with narrative delay
Scientific title
For school-age children with narrative delay is a manualised oral narrative intervention programme more effective than typical practice as measured by narrative macrostructure, microstructure and quality: A pilot study
Secondary ID [1] 283108 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral language delay 289952 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290325 290325 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase One: Designing, Manualising and Piloting the Treatment Programme
1. Design narrative programme structure and develop manual to include scope and sequence of intervention targets and parameters of intervention.
2. Map structure to intervention sessions and goals/targets for each session.
3. Develop teaching scripts for each narrative element, to include a definition, model and examples.
4. Develop scripted contingent responses for macrostructure and microstructure elements.
5. Create scoring procedure to evaluate participants’ performance for macrostructure and microstructure as well as a pre and post measure of narrative quality.

Intervention sessions will consist of a range of activities such as book sharing, story generation, picture sequencing, story re-tells and character maps. These activities are commonly used in Speech Pathology sessions with young children. Each intervention session will last for 45 minutes.

The programme will be piloted with 6 monolingual English speaking participants, aged between 5.5 and 6.5. Intervention will be carried out in 2 groups of three, 3 times a week for 6 weeks. Changes to the programme will be made as needed, based on participant engagement and clinician judgment. Reasons for changes will be documented for future reference.
Intervention code [1] 287827 0
Treatment: Other
Comparator / control treatment
Single subject repeated measures multiple baseline across participants research design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290359 0
Pre- and post-treatment data collection will use the Test of Narrative Language. Narratives will be analysed according to the test guidelines, utilizing SALT. Samples will be scored on narrative quality, using a like-ert scale. Measures of narrative quality include; amount of scaffolding and support required, use of paralinguistic features and engagement.

Gillam, R. B., & Pearson, N. A. (2004). Test of Narrative Language. Austin, TX: Pro-Ed.
Miller, J., & Iglesias, A. (2008). Systematic Analysis of Language Transcripts (SALT) [Computer Software]: LLC.
Timepoint [1] 290359 0
Pre-treatment will be carried out in the week prior to intervention commencing and post-treatment will be carried out in the week following intervention.
Primary outcome [2] 290360 0
Measures of narrative macrostructure and microstructure, will use a researcher generated analysis method to profile the samples in more detail. Measures will be collected during each intervention session.
Repeated measures analysis of the DVs will be completed using the macro and microstructure measures collected during baseline and treatment to determine change, and determine if changes are related to onset of treatment. Visual and statistical methods will be used to evaluate clinical and statistical significance.
Timepoint [2] 290360 0
During each intervention session (3 times per week for 6 weeks).
Secondary outcome [1] 304358 0
Nil
Timepoint [1] 304358 0
Nil

Eligibility
Key inclusion criteria
Six monolingual English-speaking children between the ages of 5.5 to 6.5 with narrative delay will be selected from a metropolitan mainstream school. The school will be implementing typical classroom practice that does not include explicit teaching of narrative. A parent/teacher questionnaire will be used to ensure all participants are typically developing with no evidence of significant hearing, vision, behavioural, language and educational or medical issues present.
Minimum age
5 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Evidence of significant hearing, vision, behavioural, language and educational or medical issues.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2014
Actual
3/03/2014
Date of last participant enrolment
Anticipated
Actual
14/03/2014
Date of last data collection
Anticipated
Actual
31/10/2014
Sample size
Target
9
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287862 0
University
Name [1] 287862 0
Curtin University
Country [1] 287862 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
GPO Box U1987
Perth
WA
6845
Country
Australia
Secondary sponsor category [1] 286591 0
None
Name [1] 286591 0
Address [1] 286591 0
Country [1] 286591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289805 0
Curtin University HREC
Ethics committee address [1] 289805 0
Ethics committee country [1] 289805 0
Australia
Date submitted for ethics approval [1] 289805 0
26/08/2013
Approval date [1] 289805 0
19/11/2013
Ethics approval number [1] 289805 0

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

Contacts
Principal investigator
Name 42530 0
Dr Suze Leitao
Address 42530 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
WA 6845
Country 42530 0
Australia
Phone 42530 0
+ 61 8 9266 7620
Fax 42530 0
Email 42530 0
[email protected]
Contact person for public queries
Name 42531 0
Suze Leitao
Address 42531 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
WA 6845
Country 42531 0
Australia
Phone 42531 0
+ 61 8 9266 7620
Fax 42531 0
Email 42531 0
[email protected]
Contact person for scientific queries
Name 42532 0
Suze Leitao
Address 42532 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
WA 6845
Country 42532 0
Australia
Phone 42532 0
+ 61 8 9266 7620
Fax 42532 0
Email 42532 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
No additional documents have been identified.