Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000376842
Ethics application status
Approved
Date submitted
4/02/2021
Date registered
1/04/2021
Date last updated
3/06/2024
Date data sharing statement initially provided
1/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and evaluation of the 'Learning to Lead' program for children's leadership skills
Scientific title
Effect of the 'Learning to Lead' school-based peer leadership program on primary school children's leadership skills
Secondary ID [1] 303345 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
L2L
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fundamental movement skill competency 320597 0
Physical inactivity 320598 0
Occupational stress 320599 0
Well-being 320600 0
Executive Functioning 325506 0
Physical Fitness 325507 0
Condition category
Condition code
Public Health 318454 318454 0 0
Health promotion/education
Mental Health 318456 318456 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary aim of this trial is to develop, implement, and evaluate a school-based peer leadership program, known as Learning to Lead (L2L). The program will be evaluated using a cluster randomised controlled trial, which will be conducted in two cohorts. Cohort 1 (10 schools; 5 intervention and 5 control) will be assessed for baseline measures during 2022, whereas Cohort 2 (10 schools; 5 intervention and 5 control) will be assessed for baseline measures during 2023.

The L2L program will be delivered by leaders (Stage 3 students) to peers (Stage 2 students) over one school term (10 weeks), and is informed by the tenets of transformational leadership theory.

The research team will provide a five-hour professional development workshop for teachers of Stage 3 student leaders to facilitate program delivery. The workshop to be delivered to Stage 3 teachers will involve a combination of didactic delivery, interactive discussion, short videos, and practical demonstrations/activities (e.g., completing a L2L physical activity session). The professional development workshop will occur approximately two weeks following baseline data collection.

Approximately two weeks following the professional development workshop, Stage 3 teachers will deliver 6 x 40 minute lessons to leaders. The six lessons will include a mixture of practical activities and information to support leaders to deliver the program. It will address the four dimensions of transformational leadership. These include: (i) Idealised influence, (ii) Inspirational motivation, (iii) Individualised consideration, and (iv) Intellectual stimulation. To present this framework in age-appropriate terms, we refer to the four leadership dimensions as: i) Role modelling, ii) Motivating others, iii) Considering others, and iv) Helping others to think.

Following this, peers (i.e., students in Stage 2) will be placed into groups of 4-6 students by their classroom teachers. Two-to-three leaders will be allocated to each group, and will deliver 12 x 30-min fundamental movement skill (FMS) over the course of 10 weeks (1 school Term). This program encourages Stage 2 students to perform physical activities designed to enhance fitness, and apply and refine movement skills and concepts in a range of physical activity contexts. The FMS sessions will focus on the skills of catching, kicking, throwing, dribbling, and striking. The FMS sessions will commence at the beginning of the school term, approximately two weeks after teachers have delivered all 6 x 40 minute lessons to leaders.

Stage 3 teachers will be provided with training and support to facilitate leaders’ delivery of the FMS sessions. At the end of each session, Stage 3 teachers will be encouraged to meet briefly with leaders to discuss any challenges, concerns and offer potential solutions. This will also provide an opportunity for teachers to provide general and specific feedback to leaders.

Project and school records, as well as post-intervention questionnaires completed by intervention principals, school champions (Stage 3 teachers), teachers, and leaders will be used to monitor adherence. The following strategies will be used during intervention delivery: (i) schedule from the teachers to show that the 12 sessions were delivered (or how they were made up if they had to adapt); and (ii) Leaders' attendance at the training delivered by the school champion/Stage 3 teacher.
Intervention code [1] 319653 0
Behaviour
Intervention code [2] 319654 0
Prevention
Intervention code [3] 319655 0
Lifestyle
Comparator / control treatment
The study will employ a wait-list control design. Participants randomly allocated to the control group will continue with usual school practice (i.e., normal curricular lessons) for the duration of the intervention period. Schools allocated to the control group in cohorts 1 and 2 will receive the program following final study assessments.
Control group
Active

Outcomes
Primary outcome [1] 326415 0
Leaders: Leadership effectiveness (Teachers will rate students' leadership skills using an adapted version of the Transformational Teaching Questionnaire).
Timepoint [1] 326415 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the L2L program delivered by leaders to peers.
Secondary outcome [1] 391403 0
Leaders: Leadership self-efficacy (Assessed based on a standard protocol for assessing self-efficacy beliefs as proposed by Bandura). Leaders will be asked to rate their confidence to perform the key leadership behaviors being targeted in the intervention
Timepoint [1] 391403 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the L2L program delivered by leaders to peers.
Secondary outcome [2] 391404 0
Leaders: On-task behaviour in the classroom (Research assistants will assess on-task behavior in randomly selected students using a momentary time sampling procedure).
Timepoint [2] 391404 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the L2L program delivered by leaders to peers.
Secondary outcome [3] 391405 0
Peers: Actual object control fundamental movement skill (FMS) competency (assessed using items from the Test of Gross Motor Development 3).
Timepoint [3] 391405 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the L2L program delivered by leaders to peers.
Secondary outcome [4] 391406 0
Peers: Perceived object control fundamental movement skill (FMS) competency (assessed using the Pictorial Scale of Perceived Movement Skill Competence).
Timepoint [4] 391406 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the L2L program delivered by leaders to peers.
Secondary outcome [5] 391407 0
Peers: Physical activity during school hours (Assessed using wrist-worn ActiGraph GT9X Link accelerometers for one week). Accelerometers will be distributed at the start of each school day (i.e., 9:00am) and collected at the end of each school day (i.e., 3:00pm).
Timepoint [5] 391407 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Mid-intervention (Term 3: assessed in weeks 4-10). This will occur during the delivery of the L2L program delivered by leaders to peers.
Secondary outcome [6] 391408 0
Teachers: Occupational stress (Assessed using the Teacher Stress Inventory).
Timepoint [6] 391408 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Follow-up (Term 4: assessed once during weeks 5-10). This will occur in the school term following the delivery of the L2L program.
Secondary outcome [7] 392528 0
Teacher: Teacher well-being (Assessed using the Teacher Well-Being Scale).
Timepoint [7] 392528 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Follow-up (Term 4: assessed once during weeks 5-10). This will occur in the school term following the delivery of the L2L program.
Secondary outcome [8] 407112 0
Peers: Executive Functioning - Peers will be assessed using two tests from the 'NIH Toolbox'. Executive Functioning will be assessed using the 'Flanker Inhibitory Control and Attention Test', and the 'Dimensional Change Card Sort Test'.
Timepoint [8] 407112 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the L2L program delivered by leaders to peers.
Secondary outcome [9] 407113 0
Health-related fitness (assessed using the 20m multistage fitness test and the standing long jump).
Timepoint [9] 407113 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2), This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the L2L program delivered by leaders to peers.
Secondary outcome [10] 414170 0
Leaders: Well-being (assessed using the 'Short Warwick Edinburgh Mental Well-being Scale')
Timepoint [10] 414170 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2). This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the Learning to Lead program delivered by leaders to peers.
Secondary outcome [11] 418745 0
Leaders and Peers: Prosocial behaviour (assessed using the five item Prosocial Scale taken from the Strengths and Difficulties Questionnaire)
Timepoint [11] 418745 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2). This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the Learning to Lead program delivered by leaders to peers.
Secondary outcome [12] 418746 0
Leaders: Self-Esteem (assessed using the Rosenburg Self-Esteem Scale)
Timepoint [12] 418746 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2). This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the Learning to Lead program delivered by leaders to peers.
Secondary outcome [13] 418747 0
Leaders: Empathy (assessed using the 14-item EmQue-CA Questionnaire)
Timepoint [13] 418747 0
Baseline (Term 1: assessed once during weeks 5-10, Term 2). This will occur prior to teachers' and leaders' training. Intervention end (Term 3: assessed once during weeks 5-10). This will occur at the end of the Learning to Lead program delivered by leaders to peers.

Eligibility
Key inclusion criteria
Government primary schools located within a 1-hour drive of the University of Newcastle will be eligible to participate in Cohort 1 (2022), and Government primary schools located within a 2-hour drive of the University of Newcastle will be eligible to participate in Cohort 2 (2023). Schools will be eligible to participate if they have at least two Stage 3 classes.

Eligible participants will be students in Stage 2 (peers) and 3 (leaders), and Stage 3 teachers at consenting schools.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools that are participating in any other leadership or physical activity programs.

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 to control or intervention groups will be conducted following recruitment and baseline assessments, using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following recruitment, we will match pair schools according to their size and level of socio-economic disadvantage (using My School data). Schools will be randomised by an independent researcher using a computer-based random number generator, such that one school from each pair will be allocated to the intervention condition and the remaining school will be allocated to the control condition. Using this approach, each school will have an equal chance of being allocated to the intervention condition, whilst maintaining an appropriate balance of school characteristics across the two conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The intervention will occur across two separate cohorts. Cohort 1 (10 schools; 5 intervention and 5 control) and Cohort 2 (10 schools; 5 intervention and 5 control).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: To ensure 80% power to detect a conservative effect of d = 0.50 for leadership effectiveness (adjusted between-group difference of ~0.4 units with standard deviation of 0.8), we required 128 Peer leaders for a non-clustered trial (two-tailed, p<0.05). However, as recommended by CONSORT, we adjusted our power calculation for the clustering of effects at the school level using a correction factor of [1+ (m - 1) × ICC], where m = participants per school and ICC = intraclass correlation coefficient. Assuming an average class size of 20 participating students, two classes per school and an ICC for leadership of 0.15, the correction factor is 5.68 [i.e., 1 + (40-1) × 0.15]. The required sample size to achieve 80% power with a levels set at p<0.05 is 727 (i.e., 128 x 5.68). Assuming each school has approximately 60 x Stage 3 students (2 classes), with a conservative response rate of 67% and allowing for an expected 10% loss to follow-up, we will aim to recruit at least 40 Stage 3 students from each of 20 schools (N = 800). We will also recruit 40 Stage 2 students per school (N = 800).

Statistical analysis: Analyses of primary and secondary outcomes will be conducted using linear mixed models in IBM SPSS Statistics for Windows, V.20.0 (IBM, Armonk, New York, USA). The models will be used to assess the impact of treatment (‘Learning to Lead’ or control), time (treated as categorical with levels baseline, mid-intervention and follow-up) and the group-by-time interaction. The primary end-point of the study will be intervention end (Term 3, weeks 5-10). Our analyses will be adjusted for the clustering of effects at the class and school levels, using random intercepts.

To examine whether changes in Peer leaders’ on-task behaviour mediate the effect of the L2L program on teachers’ work-related stress and well-being, we will conduct a full information statistical maximum likelihood procedure in Mplus, Version 8 that uses all available data. Structural equation models will be used to simultaneously test the following. First, the total effect of the program on work-related stress (C pathway). Second, single- and multiple-mediator models will explore evidence for mediation effects. These models will generate unstandardised regression coefficients for: (i) the effect of the intervention on the mediators (A pathways), (ii) the mediator effects on work-related stress (B pathways), and (iii) the direct effect of the L2L on work-related stress with the inclusion of mediators in the model (C' pathway). The models will also calculate the significance of the product-of-coefficients (A x B). As Mplus does not support bootstrapping with clustered data, single-level bootstrap confidence intervals will be compared with confidence intervals adjusted for clustering.

Similarly, structural equation models will be used to test: (i) the total effect of the program on executive functioning (C pathways), (ii) the effect of the program on the mediators (A pathways), (iii) the mediator effects on executive functioning (B pathways), (iv) the direct effect of the program on executive functioning with the inclusion of mediators (C’ pathways), and (v) the indirect effect of the program on executive functioning (AB pathways). As Mplus does not support bootstrapping with clustered data, single-level bootstrap confidence intervals will be compared with confidence intervals adjusted for clustering.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2022
Actual
6/04/2022
Date of last participant enrolment
Anticipated
Actual
24/03/2023
Date of last data collection
Anticipated
Actual
10/10/2023
Sample size
Target
1600
Accrual to date
Final
1900
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307762 0
Government body
Name [1] 307762 0
New South Wales Department of Education
Country [1] 307762 0
Australia
Primary sponsor type
Individual
Name
David Lubans
Address
The University of Newcastle
Level 3, ATC building
University Drive
Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 308464 0
None
Name [1] 308464 0
Address [1] 308464 0
Country [1] 308464 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307783 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 307783 0
Ethics committee country [1] 307783 0
Australia
Date submitted for ethics approval [1] 307783 0
23/03/2020
Approval date [1] 307783 0
03/07/2020
Ethics approval number [1] 307783 0
H-2020-0109
Ethics committee name [2] 307784 0
New South Wales Department of Education: State Education Research Applications Process (SERAP)
Ethics committee address [2] 307784 0
Ethics committee country [2] 307784 0
Australia
Date submitted for ethics approval [2] 307784 0
Approval date [2] 307784 0
19/10/2020
Ethics approval number [2] 307784 0
SERAP 2020143

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

Contacts
Principal investigator
Name 108482 0
Prof David Lubans
Address 108482 0
The University of Newcastle
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 108482 0
Australia
Phone 108482 0
+61 249212049
Fax 108482 0
Email 108482 0
[email protected]
Contact person for public queries
Name 108483 0
David Lubans
Address 108483 0
The University of Newcastle
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 108483 0
Australia
Phone 108483 0
+61 249212049
Fax 108483 0
Email 108483 0
[email protected]
Contact person for scientific queries
Name 108484 0
David Lubans
Address 108484 0
The University of Newcastle
Level 3, ATC Building
University Drive
Callaghan, NSW, 2308
Country 108484 0
Australia
Phone 108484 0
+61 249212049
Fax 108484 0
Email 108484 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


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.