Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001566426
Ethics application status
Approved
Date submitted
10/11/2016
Date registered
14/11/2016
Date last updated
21/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a group sensory motor approach intervention on behaviour, development and early academic skills of young children in a school setting: Results from a two-year cluster randomised controlled trial
Scientific title
Effects of a group sensory motor approach intervention on behaviour, development and early academic skills of young children in a school setting: Results from a two-year cluster randomised controlled trial
Secondary ID [1] 290443 0
None
Universal Trial Number (UTN)
U1111-1189-3392
Trial acronym
ABCDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sensory motor development 300800 0
Behaviour 300801 0
Learning 300802 0
Academic skills 300803 0
Condition category
Condition code
Public Health 300625 300625 0 0
Health promotion/education
Mental Health 300740 300740 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sensory motor approach intervention; Sensory Integration.
The Learning Connections Schools Program was administered daily in the morning for twenty minutes, in the classroom by the classroom teacher with a cluster (class) of children at each school for two years. This program involves a set of mixed sensory motor development (sensorimotor approach intervention) and sensory integration activities, such as squirming, patterned crawling, patterned walking, and visuomotor activities including repetition of sight words while undertaking movements, as well as humming, and self-soothing activities.
Teachers were provided with two days training by staff from The Learning Connections Centre, in the form of workshop group sessions with theoretical reading provided prior to the training, and audiovisual presentations during training. A further two days of follow up visits in the classroom were provided by Learning Connections Centre staff.
The study is pragmatic, recognising the fluctuations in the usual school setting with no monitoring of adherence or fidelity.
Testing on behavioural, development and academic skills was undertaken at the beginning of the first year, end of the first year and end of the second year of the trial.
Intervention code [1] 296290 0
Treatment: Other
Intervention code [2] 296291 0
Behaviour
Comparator / control treatment
Control group of similar clusters (classes) received no intervention but undertook the same testing at the same times.
Control group
Active

Outcomes
Primary outcome [1] 300141 0
To examine the effect of a sensory motor development integration program on young children's early academic skills (mathematics).
Assessed using test: Early mathematics concepts A and B.
Timepoint [1] 300141 0
Beginning of Year One of the trial (beginning of school Prep Year),
End of Year One of the trial (end of school Prep Year),
End of Year Two of the trial (end of Year 1 of schooling)
Primary outcome [2] 300142 0
To examine the effect of a sensory motor development integration program on young children's development and behaviour.
Assessed using test: Behavioural Assessment System for Children, 2nd ed.
Timepoint [2] 300142 0
Beginning of Year One of the trial (beginning of school Prep Year),
End of Year One of the trial (end of school Prep Year),
End of Year Two of the trial (end of Year 1 of schooling)
Primary outcome [3] 300143 0
To examine the effect of a sensory motor development integration program on young children's early language skills,
Assessed using tests: Astronaut Invented Spelling Test, 2nd ed.; Sutherland Phonological Awareness Test.
Timepoint [3] 300143 0
Beginning of Year One of the trial (beginning of school Prep Year),
End of Year One of the trial (end of school Prep Year),
End of Year Two of the trial (end of Year 1 of schooling)
Secondary outcome [1] 329183 0
No secondary outcomes were assessed
Timepoint [1] 329183 0
No secondary timepoints

Eligibility
Key inclusion criteria
Catholic Schools in Southeast Queensland Australia with at least one Prep class.
[Inclusion criteria pertain to schools with clusters of children in Prep year at the commencement of the study. No individual recruitment of children was undertaken]
Minimum age
4 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools that already have a sensory motor development program in place.
[Exclusion criteria pertain to schools only. No individual recruitment of children was undertaken]

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)
Schools were volunteered to participate by School Principals. Volunteering schools were randomly allocated to the intervention and control groups by central randomisation in an Excel database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation was undertaken by Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Power calculations determined a sample size of over 400 is required. Data analysis will be undertaken using SPSS Version 23 and Generalized Estimations Equation modelling.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/01/2012
Date of last participant enrolment
Anticipated
Actual
23/01/2012
Date of last data collection
Anticipated
Actual
13/12/2013
Sample size
Target
600
Accrual to date
Final
480
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294933 0
Commercial sector/Industry
Name [1] 294933 0
Queensland Catholic Education Commission, Directors
Country [1] 294933 0
Australia
Funding source category [2] 294937 0
University
Name [2] 294937 0
Australian Catholic University
Country [2] 294937 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
40 Edward Street,
North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 293764 0
Charities/Societies/Foundations
Name [1] 293764 0
The Learning Connections Centre
Address [1] 293764 0
Level 4 Lang Park PCYC,
Castlemaine St,
Paddington QLD 4064
Country [1] 293764 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296306 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 296306 0
40 Edward Street,
North Sydney NSW 2060
Ethics committee country [1] 296306 0
Australia
Date submitted for ethics approval [1] 296306 0
10/10/2011
Approval date [1] 296306 0
02/12/2011
Ethics approval number [1] 296306 0
Q2010 56

Summary
Brief summary
The overall aim of this research is to explore the effects of a program of sensory motor integration activities, The Learning Connections Schools Program, on young children’s behaviour, development and early academic skills.

In order to achieve this aim, the objectives are to:
*Conduct a cluster, pragmatic, unblinded, controlled trial to investigate the effect of a program of sensory motor integration activities on behaviour, development and academic skills in children in Prep Year and Year 1 of school.
*Implement the sensory motor integration program with a group of children (the experiment / intervention group) in Prep Year and Year 1, across a variety of schools
*Determine the effects of this program on behaviour, development and academic skills in that group of children by examining before and after measures
*Compare the results from these children to the results for a control group of children in the same years of schooling, from similar schools, who have not participated in the sensory motor integration program.

Sample
All Brisbane Catholic Education primary schools have been invited to participate. Of those that volunteered, 12 will be randomly selected to participate using a computer-based random number generator selection process (randomisation). School Principals will then be required to consent to their school participating in the research. As well teachers will be asked to consent to participation in the research, and parents will be asked to consent for their children to undertake the sensory motor program in class and undertake the assessments as part of usual classroom activities. The final sample will consist of six (6) control schools (3 urban; 3 rural/semirural/regional) and six (6) experimental schools (3 urban; 3 rural/semirural/regional). Based on the average school with an intake PREP year of 50-60 pupils (with an average class size of n = 25-30), this will result in an expected sample size of between 600 to 720 pupils across 12 schools.

Inclusion criteria
*All Brisbane Catholic primary schools with PREP year and Year 1 classes.
Exclusion criteria
*Schools with existing sensory motor integration programs (for the control group)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70110 0
Prof Paul Fulbrook
Address 70110 0
School of Nursing, Midwifery & Paramedicine (Brisbane),
Australian Catholic University,
1100 Nudgee Road,
Banyo QLD 4014
Country 70110 0
Australia
Phone 70110 0
+61 7 3139 4087
Fax 70110 0
Email 70110 0
[email protected]
Contact person for public queries
Name 70111 0
Ms Sandra Miles
Address 70111 0
School of Nursing, Midwifery & Paramedicine (Brisbane),
Australian Catholic University,
1100 Nudgee Road,
Banyo QLD 4014
Country 70111 0
Australia
Phone 70111 0
+61 7 3623 7293
Fax 70111 0
Email 70111 0
[email protected]
Contact person for scientific queries
Name 70112 0
Ms Sandra Miles
Address 70112 0
School of Nursing, Midwifery & Paramedicine (Brisbane),
Australian Catholic University,
1100 Nudgee Road,
Banyo QLD 4014
Country 70112 0
Australia
Phone 70112 0
+61 7 3623 7293
Fax 70112 0
Email 70112 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.