Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000954820p
Ethics application status
Submitted, not yet approved
Date submitted
14/05/2021
Date registered
21/07/2021
Date last updated
21/07/2021
Date data sharing statement initially provided
21/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of a self-regulation intervention in primary schools: An occupational therapy approach
Scientific title
Evaluating the effect of a self-regulation intervention on primary school children's perception of their well-being and self-regulation: An occupational therapy approach
Secondary ID [1] 304051 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Student well-being 321735 0
Condition category
Condition code
Mental Health 319475 319475 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stage 1
Objective: Identifying engine speeds
Pre-intervention training: Participating teachers must attend training with the occupational therapist in Week 1 of Term 2 1x3hr session delivered in face to face group session subject to general health recommendations during the global pandemic.
Baseline assessment: Week 1 of Term 2
Frequency: 1 hour per week
Timeline: Weeks 2-4 of Term 2
Monitoring: The occupational therapist will meet with participating classroom teachers on a regular basis to discuss the program, including teacher adherence to activities outline in the intervention manual (designed specifically for this study based on the How Does your Engine run training manual). Class attendance will be monitored.
Sessions:
i. Learning engine words; learning to identify and label engine levels in others; and developing awareness and feel of different engine speeds
ii. Continuation of learning engine words and labels in others as above
iii. Learning to identify and label engine levels in themselves

Stage Two
Objective: Experimenting with Methods to Change Engine Speeds
Frequency: 1 hour per week
Timeline: Weeks 5-9 of Term 2
Monitoring: The occupational therapist will meet with participating classroom teachers on a regular basis to discuss the program, including teacher adherence to activities outline in the intervention manual. Class attendance will be monitored. Students will be provided with a booklet (designed specifically for this study) at in session V, to monitor there sensory preferences and begin developing their engine toolkit to use in Term 3.
Sessions:
iv. Tools for the mouth
v. Tools for the body and hands
vi. Tools for the eyes
vii. Tools for the ears
viii. Program review- this will include a review of all content covered in weeks 2-8, as well as a brief in-class popular quiz for the participating students.

Stage Three
Objective: Regulating Engine Speeds
Timeline: Weeks 1-11 of Term 3
Sessions: This component will be included as part of the intervention, with classroom teachers delivering additional interactional activities at their discretion in Term 3. Classroom teachers are expected to adhere to this. Research team will provide participating teachers with suggestions describing how to embed the concepts and language from Stage 1 and Stage 2 throughout the school week.
Monitoring: The occupational therapist will meet with participating classroom teachers on a regular basis to discuss the program, including teacher adherence to activities outline in the intervention manual (designed specifically for this study), as well as use of the engine toolkit booklet provided in session V (designed specifically for this study).
Post-intervention assessment: baseline assessments repeated in Week 10 of Term 3
Intervention code [1] 320407 0
Prevention
Comparator / control treatment
Classes will maintain their regular routines, structures, and management processes and practices.
Control group
Active

Outcomes
Primary outcome [1] 327350 0
Child perception of well-being as assessed by the Rumbles Quest

Timepoint [1] 327350 0
Pre-intervention (baseline), post-intervention & 12 weeks following intervention.
Secondary outcome [1] 394678 0
Social adaptation of students as assessed by the Teacher Observation of Child Adaptation - Checklist
Timepoint [1] 394678 0
Pre-intervention (baseline), post-intervention & 12 weeks following intervention.
Secondary outcome [2] 394680 0
School behaviour as assessed by school administration data (behavioural reports/ suspension data & absenteeism data.)
Timepoint [2] 394680 0
Pre-intervention (baseline), post-intervention & 12 weeks following intervention.
Secondary outcome [3] 396729 0
This study explicitly reviews the cost associated with running the school Alert program. We will cost the school Alert program through recording time spent by OT, equipment used by OT and time spent by teacher(s) participating in this program. This will provide a comprehensive overview of the cost of the Alert program in terms of staffing and equipment.
Timepoint [3] 396729 0
Immediately after the last session follow up will occur 10 weeks later.

Eligibility
Key inclusion criteria
The research will be conducted at two primary school sites in The Hunter Region, New South Wales. Two schools with similar enrolment numbers, teaching pedagogies and socioeconomic status (e.g. 2020/2021 funding allocation, Family Occupation and Education Index [FOEI] via the www.myschool.edu.au website were identified by student supervisor (CL). Participating schools need to meet the following inclusion criteria:
• Have the closest alignment with these conditions
• Do not/have not received prior occupational therapy clinical services from The University of Newcastle Occupational Therapy Clinic
• Within 50km of Newcastle CBD

Stage 2 students from the included classes will be eligible to participate.
Minimum age
8 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools currently receiving services from The University of Newcastle Occupational Therapy Clinic will not be eligible to participate in this study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using a randomised database external to the CI.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be checked for normality, and descriptive statistics will be run to report key baseline demographics of participants. If the data retains normality, inferential statistics, including independent samples t-test and analysis of variance will be implemented to examine the effectiveness of the intervention on child, teacher and academic outcomes between the control and test groups. These statistical measures will determine whether statistically significant changes in self-regulation occur following implementation of the class-wide program.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/04/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308469 0
University
Name [1] 308469 0
University of Newcastle
Country [1] 308469 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 309266 0
None
Name [1] 309266 0
Address [1] 309266 0
Country [1] 309266 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308392 0
University of Newcastle
Ethics committee address [1] 308392 0
Human Research Ethics Committee
University Drive
Callaghan NSW 2308
Ethics committee country [1] 308392 0
Australia
Date submitted for ethics approval [1] 308392 0
12/04/2021
Approval date [1] 308392 0
Ethics approval number [1] 308392 0

Summary
Brief summary
We aim to examine the clinical effectiveness and economic benefit of a whole of class self-regulation program in mainstream schools.
We aim to: 1) improve the self-regulation skills of school-aged children experiencing social disadvantage and 2) determine the cost of an occupational therapy service delivering the intervention.
Participants: Eligible Stage 2 students from two separate schools, one as the control group and the other an intervention group. Participants will be children aged 8-10 years, and their classroom teacher.
Methods: a control group and treatment group will be utilised to establish a cause and effect relationship between a whole class occupational therapy led self-regulation program, and the selfregulation skills of participants.

Hypotheses: we expect that the self-regulation skills of children in the treatment group will show more improvement over time than the control group. A reduction in behavioural incidents, suspensions and absenteeism is also expected.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110558 0
Dr Kylie Wales
Address 110558 0
University of Newcastle
Hunter Building
University Drive
Callaghan NSW 2308
Country 110558 0
Australia
Phone 110558 0
+61 02 49138073
Fax 110558 0
Email 110558 0
[email protected]
Contact person for public queries
Name 110559 0
Dr Kylie Wales
Address 110559 0
University of Newcastle
Hunter Building
University Drive
Callaghan NSW 2308
Country 110559 0
Australia
Phone 110559 0
+61 02 49138073
Fax 110559 0
Email 110559 0
[email protected]
Contact person for scientific queries
Name 110560 0
Dr Kylie Wales
Address 110560 0
University of Newcastle
Hunter Building
University Drive
Callaghan NSW 2308
Country 110560 0
Australia
Phone 110560 0
+61 02 49138073
Fax 110560 0
Email 110560 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an unfunded study. There is no resourcing available to have participant data available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11522Study protocol  [email protected] We are currently submitting the protocol for publi... [More Details]
11523Clinical study report    This will be available at the end of the study.
11524Ethical approval  [email protected] Once approved this will be available via the PI



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.