Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001109796
Ethics application status
Approved
Date submitted
2/10/2013
Date registered
3/10/2013
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A 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
Secondary ID [1] 283345 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral language delay 290238 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290629 290629 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase Two: Evaluating the efficacy of the narrative intervention
The second phase of this study, which follows on from the pilot study ACTRN12613001108707) will involve administering the narrative intervention programme to determine efficacy of the programme.

Treatment sessions will occur at a selected school within the North East Metropolitan Education Region. Treatment will occur with 12 participants in small groups of three-four, three times a week for a period of six weeks. Participants will be monolingual English speaking, and aged between 5.5 and 6.5. The primary researcher will conduct the treatment sessions and all treatment sessions will be video and audio recorded with consent for later data analysis.

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.

Intervention code [1] 288066 0
Treatment: Other
Comparator / control treatment
Single subject repeated measures multiple baseline across participants research design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290642 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] 290642 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] 290643 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] 290643 0
During each intervention session (3 times per week for 6 weeks).
Secondary outcome [1] 304968 0
nil
Timepoint [1] 304968 0
n/a

Eligibility
Key inclusion criteria
Twelve 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
15/03/2014
Date of last participant enrolment
Anticipated
Actual
1/05/2014
Date of last data collection
Anticipated
Actual
31/10/2014
Sample size
Target
12
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 288074 0
University
Name [1] 288074 0
Curtin University
Country [1] 288074 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
GPO Box U1987
Perth
WA
6845
Country
Australia
Secondary sponsor category [1] 286796 0
None
Name [1] 286796 0
Address [1] 286796 0
Country [1] 286796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290001 0
Curtin University HREC
Ethics committee address [1] 290001 0
Ethics committee country [1] 290001 0
Australia
Date submitted for ethics approval [1] 290001 0
26/08/2013
Approval date [1] 290001 0
19/11/2013
Ethics approval number [1] 290001 0

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

Contacts
Principal investigator
Name 42522 0
Dr Suze Leitao
Address 42522 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
WA 6845
Country 42522 0
Australia
Phone 42522 0
+ 61 8 9266 7620
Fax 42522 0
Email 42522 0
[email protected]
Contact person for public queries
Name 42523 0
Suze Leitao
Address 42523 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
WA 6845
Country 42523 0
Australia
Phone 42523 0
+ 61 8 9266 7620
Fax 42523 0
Email 42523 0
[email protected]
Contact person for scientific queries
Name 42524 0
Suze Leitao
Address 42524 0
School of Psychology & Speech Pathology
Curtin University
GPO Box U1987
Perth
WA 6845
Country 42524 0
Australia
Phone 42524 0
+ 61 8 9266 7620
Fax 42524 0
Email 42524 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.