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Trial registered on ANZCTR


Registration number
ACTRN12618002045291
Ethics application status
Approved
Date submitted
19/12/2018
Date registered
21/12/2018
Date last updated
21/12/2018
Date data sharing statement initially provided
21/12/2018
Date results information initially provided
21/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Acceptability and Feasibility Trial of the Good Behaviour Game in Australian Primary Schools
Scientific title
Exploring early pathways to mental illness and related harms: An implementation feasibility and acceptability study of the Good Behaviour Game in Australian Primary Schools
Secondary ID [1] 296903 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 310849 0
Behavioural problems 310850 0
Emotional problems 310851 0
Condition category
Condition code
Mental Health 309524 309524 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PAX Good Behaviour Game is a teacher-delivered program, designed to be embedded into usual classroom activities. The program is made up of multiple ‘kernels’ (i.e., evidence-based behavioural contingencies) which include:
1. Classroom Vision (sets out the agreed desirable and undesirable behaviours),
2. PAX Hands (a thumbs up/thumbs down card worn by teachers to discreetly point out to students when they are doing the right or wrong thing - and not draw attention of the whole class to the behaviour)
3. PAX Quiet (use of a harmonica to gain the children’s attention and achieve silence)
4. Granny’s wacky prizes (rewards for desirable behaviours)
5. Beat the Timer (the primary part of the program in which children are split into teams, a timer is set, and children work on task for the amount of time specified by the teacher. Children/teams who stay on task are rewarded at the end of the playing period)
6. Tootle Notes (students write positive notes about each other to reinforce positive relations between students).
7. PAX Voice (using hand signals to teach children how to modulate noise in the classroom)
8. PAX Leader (children chosen for leadership roles in the classroom to develop confidence and increase investment in the program)
The kernels are designed to be used throughout the day to encourage desirable behaviour and to teach children to make positive choices.

While the kernels can be used individually throughout the day, the ‘beat the timer’ part of the program is the key component which teaches self- and co-regulation. During ‘beat the timer’ the students are divided into small teams, where known disruptive students, or known shy/anxious students, are distributed evenly among the teams to create equilibrium in the classroom. The teacher then sets the timer for how long the ‘game’ will be played, and students have to work within their teams to engage in on-task/desirable behaviours until the timer ends. Any off-task or less desirable/unwanted behaviours receive one point, and at the end of the playing period, teams with three or fewer points are rewarded. When the program is first delivered, rewards are given immediately following a ‘beat the timer’ game, and then are increasingly delayed, to teach delayed self-gratification. This part of the program is played up to 3 times per day, from 10 to 40 minutes (games get longer and more frequent over time), as the children’s self-regulation and behaviour improves.

In this study, the Good Behaviour Game is delivered for 12 weeks, with the expectation that teachers will deliver the primary part of the intervention (beat the timer) at least once per day for the trial's duration. In addition, at least one of the remaining eight kernels need to be delivered once per day, with teachers' having discretion regarding which kernel or kernels they will deliver.

Adherence to the intervention is monitored in two key ways:
1. Four x classroom observations per classroom by a research officer trained in the Good Behaviour Game;
2. A teacher maintained daily log of the number of times Beat the Timer was played per day, for how long, which team/s won, and the number of spleems per 'game', as well as other kernels used and issues arising. The log could be kept via the PAX Up! app, and teachers were provided tablets for this purpose. A paper version of the log was also provided for teachers who preferred not to use the app.
Intervention code [1] 313173 0
Behaviour
Comparator / control treatment
The study did not include a control group due to the purpose of the study being to establish feasibility and acceptability, rather than effectiveness
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308480 0
Acceptability of the program. An eight-item Intervention Acceptability Scale was developed to assess adherence to, and adoption of, the program. Each item was designed to assess a different domain of acceptability (e.g., perceived usefulness, ease of use, enjoyment, and comprehension), and therefore item scores were considered separately as well as globally (maximum score 18, higher scores indicate greater acceptability).
Timepoint [1] 308480 0
Immediately post-intervention using quantitative questionnaires with teachers, supplemented by in-depth qualitative interviews - these had to be conducted within four-weeks post-intervention.
Primary outcome [2] 308498 0
Feasibility of the program. An eight-item Intervention Feasibility Scale was developed to assess whether and how conveniently the Good Behaviour Game program could be delivered in Australian schools. Each item was designed to assess a different domain of feasibility (e.g., training burdensome, access to materials, willingness to implement, buy-in of school leaders), and therefore item scores were considered separately as well as globally (maximum score 13, higher scores indicate greater feasibility).
Timepoint [2] 308498 0
Immediate post-intervention using quantitative questionnaires with teachers.
Secondary outcome [1] 355113 0
Change in childhood emotional problems measured using the Strengths and Difficulties Questionnaire.
Timepoint [1] 355113 0
Change in score between baseline and following the 12-week intervention
Secondary outcome [2] 355169 0
Change in childhood behavioural problems measured using the Strengths and Difficulties Questionnaire.
Timepoint [2] 355169 0
Change in score between baseline and following the 12-week intervention

Eligibility
Key inclusion criteria
Schools were invited to participate in the study if:
They were an Independent school in New South Wales or Victoria, Australia
They had teachers in Grades 1 through to 6 who were willing to trial a classroom-based intervention
They had a minimum of 15 students in each class

All students received the Good Behaviour Game if the school principal agreed for their school to participate in the trial,
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Government and Catholic schools were excluded from the trial.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
A single-arm non-experimental trial of 6 primary schools in greater Sydney (NSW) and Warrnambool (Victoria), involving n=11 teachers and n=200 students.

There are two measurement occasions:
Wave 1: Pre-intervention in which teacher-rated SDQ data is collected for all students in the class, and teacher questionnaire to assess stigma to child mental health, awareness of mental health problems, and acceptability of program training.
Wave 2: Post-intervention in which teacher-rated SDQ data is collected for all students in the class, and teacher questionnaire to assess the acceptability and feasibility of program training.
Follow-up qualitative interview to further explore acceptability of the intervention,
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative data (SDQ) will be analysed using an ANOVA approach to test change in pre-post test scores. The feasibility of implementation will be assessed using descriptive and simple inferential techniques, such as chi-square and t-test/pairwise comparisons, as well as qualitative analysis to identify key themes around challenges encountered.

The proposed sample size is n=200 which will be able to address pre-post change on psychopathology measures so we can estimate effect size in a fully powered trial. We have used an effect size estimate of d=0.30 from the literature for behavioural outcomes. To detect an effect size of 0.30 between pre-post, with alpha at .05 and power at 0.8, we need 119 subjects. Our sample accounts for 40% attrition. The sample size of n=11 teachers usign mixed-methods is suitable for assessing feasibility and acceptability.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
16/04/2018
Date of last participant enrolment
Anticipated
Actual
20/08/2018
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
200
Accrual to date
Final
230
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 25214 0
2031 - Randwick
Recruitment postcode(s) [2] 25215 0
2145 - Westmead
Recruitment postcode(s) [3] 25216 0
2770 - Mount Druitt
Recruitment postcode(s) [4] 25217 0
2100 - Oxford Falls
Recruitment postcode(s) [5] 25218 0
3280 - Warrnambool

Funding & Sponsors
Funding source category [1] 301470 0
Charities/Societies/Foundations
Name [1] 301470 0
Society of Mental Health Research
Country [1] 301470 0
Australia
Funding source category [2] 301497 0
Commercial sector/Industry
Name [2] 301497 0
Perpetual IMPACT fund
Country [2] 301497 0
Australia
Primary sponsor type
Individual
Name
Helen Christensen
Address
Black Dog Institute
University of New South Wales
Hospital Road, Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 301190 0
None
Name [1] 301190 0
Address [1] 301190 0
Country [1] 301190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302215 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 302215 0
University of New South Wales,
Sydney, NSW, 2052
Ethics committee country [1] 302215 0
Australia
Date submitted for ethics approval [1] 302215 0
02/02/2018
Approval date [1] 302215 0
21/03/2018
Ethics approval number [1] 302215 0
HC180034

Summary
Brief summary
Poor mental health has been identified as key factor in multiple risk behaviours that contribute to premature mortality and disability. Reducing liability to mental illness at the population level (e.g., universally), appears to be crucial to disrupting trajectories to mental disorder and related harms. For successful prevention, however, interventions need to be implemented early enough to effect real change. Yet, the majority of ‘early’ universal prevention research occurs in adolescence, in secondary schools, when mental illness is already rapidly increasing. As it is strongly empirically supported that mental illness has origins in childhood, intervening in early-to-mid childhood is likely to achieve significant preventative gains. Despite this, comparatively little evidence-based prevention occurs in this developmental period. We propose a small feasibility study to trial a universal prevention program in a mid-childhood cohort (the ‘Good Behaviour Game’ [GBG]). This program has been extensively evaluated, and been shown to significantly reduce conduct disorder, ASPD, anxiety and depression, drug and alcohol dependence, and suicide attempt, with effects sustained into early adulthood. Given its expected benefits, it is important to test whether the GBG can be delivered as intended in an Australian setting, and whether it is acceptable to schools. Such work will provide empirical justification for the next iteration, i.e., a full-scale trial. This trial focuses on establishing acceptability and feasibility of the program in Australian primary schools, and providing preliminary evidence for efficacy of the program in reducing emotional and behavioural problems.
Trial website
https://www.blackdoginstitute.org.au/research/key-research-areas/prevention-in-young-people/good-behaviour-game
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89474 0
Dr Michelle Tye
Address 89474 0
Black Dog Institute
University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 89474 0
Australia
Phone 89474 0
+61 293829289
Fax 89474 0
Email 89474 0
[email protected]
Contact person for public queries
Name 89475 0
Victoria Rasmussen
Address 89475 0
Black Dog Institute
University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 89475 0
Australia
Phone 89475 0
+61 293829289
Fax 89475 0
Email 89475 0
[email protected]
Contact person for scientific queries
Name 89476 0
Michelle Tye
Address 89476 0
Black Dog Institute
University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 89476 0
Australia
Phone 89476 0
+61 293829289
Fax 89476 0
Email 89476 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
We have collected limited, single purpose data for the trial which will be published in journals. Outside of the planned publications, there would be extremely limited capacity to analyse the data in any other way.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Torok, M., Rasmussen, V., Wong, Q., Werner-Seidle... [More Details]

Documents added automatically
No additional documents have been identified.