Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000573459
Ethics application status
Approved
Date submitted
21/04/2016
Date registered
3/05/2016
Date last updated
21/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact on writing alphabet symbols using an orthographic handwriting programme (The Secret Code), for children with handwriting difficulties, in year one or two of primary school.
Scientific title
Impact on writing alphabet symbols using an orthographic handwriting programme (The Secret Code), for children with handwriting difficulties, in year one or two of primary school.
Secondary ID [1] 289058 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children in year one or two, who have no known neurological diagnosis but have difficulty with learning to write. 298500 0
Condition category
Condition code
Other 298594 298594 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase A - Samples of the child's writing is taken from class to measure and as well the child will visit the researcher (experienced occupational therapist) where they will be recorded writing the alphabet and a sentence. This will occur over a minimum of 3 weeks and no more than 6 weeks, to determine a stable baseline of the child's writing performance from in class handwriting instruction.

Phase B - The intervention being tested, is the 'Secret Code', a novel orthographic handwriting programme, to help children in year one or two, who are having difficulty learning to write. The children will visit the researcher (experienced occupational therapist), for an individual one-on-one session, twice a week for ten weeks, for forty five minute sessions. The "Secret Code' intervention includes -
Teaching the children the eight shape components that alphabet letters are constructed from and ensure they understand direction, orientation and the colour and name of each of these shapes
The children then learn how each alphabet letter is constructed with these stroke component shapes. Because many children with difficulty learning to write have memory problems, this step utilises memory strategies such as association, stories and colour.
Once this step has been achieved the children learn how these shape components are placed on the dotted third lined paper and this is a crucial step that ensures legibility of their writing.
From here children learn the concepts necessary to write a legible sentence such as the spaces necessary between letters in words, spaces between words and punctuation.
Slowly the programme layers on new learning to help children learn how to write longer text.

The first steps mentioned are what will be taught in the research study. There is no technology used, just teaching and using writing instruments.

Second Phase A - This phase is similar to the first Phase A and will begin six weeks after the conclusion of the Phase B (intervention phase) and will occur over three weeks. During this phase, like with the first Phase A, a minimum of six samples of the child's writing will be collected and recorded, Samples will be taken from in class writing activities and also the researcher will observe the children writing the alphabet and a sentence, This phase is to determine if the child's handwriting performance post the intervention phase has been maintained or changed in anyway when they have returned to classroom teaching alone.
Intervention code [1] 294563 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298081 0
To determine the impact of an orthographic handwriting program (the Secret Code) on the ability of children with handwriting difficulties in Year One or Two at primary school, to write the letters of the alphabet.

The outcome will be assessed using the PRPP (Perceive, Recall, Plan Perform) Task Analysis Stage One and Stage two from the researcher (experienced occupational therapist) observing the child writing the alphabet and from handwritten work completed in class.
Timepoint [1] 298081 0
The child will be assessed weekly throughout the ten week intervention programme.
Primary outcome [2] 298118 0
To determine the impact of an orthographic handwriting program (the Secret Code) on the ability of children with handwriting difficulties in Year One or Two at primary school, to write a sentence.

The outcome will be assessed using the PRPP (Perceive, Recall, Plan Perform) Task Analysis Stage One and Stage two from the researcher (experienced occupational therapist) observing the child writing a sentence and from handwritten work completed in class.
Timepoint [2] 298118 0
The child will be assessed weekly throughout the ten week intervention programme.
Secondary outcome [1] 323218 0
To measure ability to write letters or the alphabet and a sentence post intervention.

The outcome will be assessed using the PRPP (Perceive, Recall, Plan Perform) Task Analysis Stage One and Stage two from the researcher (experienced occupational therapist) observing the child writing the alphabet and from handwritten work completed in class.
Timepoint [1] 323218 0
Six samples of the child's writing from in class and from observation by the researcher (experienced occupational therapist) will be assessed over a three week period in Second Phase A (six weeks after the conclusion of Phase B - intervention phase).

Eligibility
Key inclusion criteria
Once consent has been received from the parents for their child to participate in the study, the child will be screened to determine if they fit the criteria for eligibility to be included in the research. The eligibility for the inclusion in the study is
Attend regular primary schools and be in grade one or two.
Have no known neurological deficits or diagnosis such physical impairment, vision impaired, hearing impaired, speech impaired, intellectual delay or autism.
Score 60% or less on the Stage One of the Mastery of the PRPP assessment of writing the alphabet.
Minimum age
6 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If the child does not meet the inclusion criteria -
not in the correct age bracket
have a diagnosis (as listed in the inclusion criteria)
unable to speak fluent English
score above 60 % on the Stage One of the Mastery of the PRPP assessment of writing the alphabet.

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)
This study is a pilot study, utilising a non-concurrent, Single System Research Design (SSRD). For this reason, any children that meat the selection criteria can participate if they and their parents / guardian, provide their consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children will be recruited and included in the study as they are referred, until the total number of ten children has been reached.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study will be using an ABA format -
Phase A - establishing a baseline of performance of handwriting from classroom instruction alone
Phase B - a ten week intervention phase
Second A phase - after a six week break from the conclusion of the intervention phase (phase B), Phase A will be repeated to determine how the child's handwriting has changed (or not changed) or the skills have been maintained or not maintained after the intervention has ceased.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis
Data from PRPP Stage One and Stage Two task analyses will be calculated as a percentage of task mastery, graphed and entered into SPSS (Version 22). 6 separate graphs depicting obtained scores will be generated including: PRPP Stage One Total Score, PRPP Stage Two Total score: PRPP Perceive Quadrant Score, PRPP Recall Quadrant Scores, PRPP Plan Quadrant Score and PRPP Perform Quadrant Score. Each data point observed on the graphs represents an analysis of handwriting task mastery in relation to the expected outcome. The data will be checked for serial dependency. Data analysis will then be carried out in the following step-wise fashion: visual analysis, semi-statistical analysis and finally, statistical analysis which will be used to confirm visual analysis (Ottenbacher, 1986). Significance level will be set at 0.05.
Analysis will examine the changes within and between the phases and will include:
*descriptive statistics of the sample
*graphing scores generated by each variable’s data collection point across the three phases;
*visual analysis of the changes in mean, variability, trend and slope of the data within and between phases (Kazdin, 2011).
*semi-statistical analysis of differences between the phases using the two standard deviation band method (Ottenbacher), 1987)
*follow-up statistical analysis of the differences between the phases (Kazdin, 2011; Ottenbacher, 1987).
*Inter-rater agreement of the independent ratings will be obtained on one third of the data by an occupational therapist trained in the assessment protocol. Intra-rater reliability will be established on one third of the data by reviewing the scoring via video analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/05/2016
Actual
23/05/2016
Date of last participant enrolment
Anticipated
22/08/2016
Actual
12/09/2016
Date of last data collection
Anticipated
Actual
7/12/2016
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 13166 0
6003 - Highgate
Recruitment postcode(s) [2] 13199 0
6010 - Claremont

Funding & Sponsors
Funding source category [1] 293437 0
Self funded/Unfunded
Name [1] 293437 0
Kathryn Mathwin
Country [1] 293437 0
Australia
Primary sponsor type
Individual
Name
Kathryn Mathwin
Address
Kathryn Mathwin Occupational Therapy
5 Princess Rd
Claremont
Western Australia 6010
Country
Australia
Secondary sponsor category [1] 292261 0
None
Name [1] 292261 0
Address [1] 292261 0
Country [1] 292261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294884 0
The University of Sydney
Ethics committee address [1] 294884 0
Ethics committee country [1] 294884 0
Australia
Date submitted for ethics approval [1] 294884 0
24/03/2016
Approval date [1] 294884 0
04/05/2016
Ethics approval number [1] 294884 0

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

Contacts
Principal investigator
Name 65330 0
Dr Christine Chapparo
Address 65330 0
Senior Lecturer
University of Sydney
Faculty of Health Sciences
NSW 2006
Country 65330 0
Australia
Phone 65330 0
+ 61 2 9351 9206
Fax 65330 0
Email 65330 0
[email protected]
Contact person for public queries
Name 65331 0
Kathryn Mathwin
Address 65331 0
Kathryn Mathwin Occupational Therapy
5 Princess Rd
Claremont
Western Australia 6010
Country 65331 0
Australia
Phone 65331 0
+61 428 187 983
Fax 65331 0
Email 65331 0
[email protected]
Contact person for scientific queries
Name 65332 0
Christine Chapparo
Address 65332 0
Senior Lecturer
University of Sydney
Faculty of Health Sciences
NSW 2006
Country 65332 0
Australia
Phone 65332 0
+ 61 2 9351 9206
Fax 65332 0
Email 65332 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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