ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Student well-being

Condition category

Condition code

Mental Health

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]

Prevention

Comparator / control treatment

Classes will maintain their regular routines, structures, and management processes and practices.

Control group

Active

Outcomes

Primary outcome [1]

Child perception of well-being as assessed by the Rumbles Quest

Timepoint [1]

Pre-intervention (baseline), post-intervention & 12 weeks following intervention.

Secondary outcome [1]

Social adaptation of students as assessed by the Teacher Observation of Child Adaptation - Checklist

Timepoint [1]

Pre-intervention (baseline), post-intervention & 12 weeks following intervention.

Secondary outcome [2]

School behaviour as assessed by school administration data (behavioural reports/ suspension data & absenteeism data.)

Timepoint [2]

Pre-intervention (baseline), post-intervention & 12 weeks following intervention.

Secondary outcome [3]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Newcastle

Address [1]

University Drive, Callaghan NSW 2308

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive
Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

University of Newcastle

Ethics committee address [1]

Human Research Ethics Committee
University Drive
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/04/2021

Approval date [1]

Ethics approval number [1]

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

Dr Kylie Wales

Address

University of Newcastle
Hunter Building
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 02 49138073

Fax

[email protected]

Contact person for public queries

Name

Kylie Wales

Address

University of Newcastle
Hunter Building
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 02 49138073

Fax

[email protected]

Contact person for scientific queries

Name

Kylie Wales

Address

University of Newcastle
Hunter Building
University Drive
Callaghan NSW 2308

Country

Australia

Phone

+61 02 49138073

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email	Other Details
11522	Study protocol	[email protected]	We are currently submitting the protocol for publi... [More Details]
11523	Clinical study report		This will be available at the end of the study.
11524	Ethical 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.

Trial Review

Documents added manually

Documents added automatically