Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001054101
Ethics application status
Approved
Date submitted
28/06/2019
Date registered
26/07/2019
Date last updated
26/07/2019
Date data sharing statement initially provided
26/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Resilience Project: an exploratory trial of a resilience promotion intervention in Victorian primary schools
Scientific title
The impact of The Resilience Project on uptake of behavioural strategies relating to gratitude, kindness and mindfulness in primary school settings: a mixed methods exploratory trial.
Secondary ID [1] 298105 0
None
Universal Trial Number (UTN)
U1111-1232-5846
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Resilience 313496 0
Emotional wellbeing 313497 0
Condition category
Condition code
Public Health 311917 311917 0 0
Health promotion/education
Mental Health 311918 311918 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TIDIER checklist
Brief name: The Resilience Project Evaluation
Why: Child and youth mental health problems are highly prevalent globally. Resilience refers to an individual’s capacity to continue to function and adapt to major life disruptions and significant adversity. The Resilience Project’s school-based program aims to improve resilience of children and create a supportive school community through a coordinated program of presentations, teacher focused curriculum materials, and personal student journals.
What
Materials:
Face-to-face presentations (1 to 1.5 hours each) by one of two staff members of the Resilience Project, both of whom hold teaching qualifications. Presentations are motivational and focus on use of daily strategies such as mindfulness, kindness, and gratitude to promote emotional wellbeing and personal resilience. Presentations are delivered in a school setting, commencing with presentations to teaching staff, following by student presentations and concluding with a presentation to parents/guardians.
In addition to the initial presentation, school teaching staff receive a Professional Development session (approx. 1 hour) run by The Resilience Project schools coordinator to describe implementation of the Resilience Project curriculum in classrooms, through use of the teacher resource and student journal.
Curriculum materials: Teacher resource including 30 lesson plans (to be delivered at each teacher’s discretion but recommended 1 per week) delivered by the primary school classroom teacher. Lesson plans focus on teaching students strategies for using gratitude, kindness and mindfulness to improve resilience.
A corresponding student journal is provided to all students participating in the program to be used with Resilience curriculum lessons delivered by teachers.
All materials used in the intervention, including the ‘teacher resource’ and the ‘student journal’ are developed and owned by the Resilience Project and used in their regular school-based program and have not been altered for the trial.
Tailoring: Lesson plans were developed to fit with Australian national curriculum and are tailored to students’ year level to suit children’s development. Materials and presentations are identical for all schools, however classroom teachers have discretion in how lesson plans are delivered throughout the school year in order to fit around regular classroom teaching.

Strategies to maintain or improve fidelity
The evaluation is designed to assess the different components of the intervention including fidelity. Three waves of quantitative data collection will be conducted: Wave 1 - before the initial presentations; Wave 2 approximately 1 month after the presentations to capture their initial impact; and Wave 3 will assess the combined impact of the curriculum and presentations over time. Wave 3 will take place approximately 6 months after the teacher professional development sessions which is assumed to be the starting point of curriculum delivery. Fidelity of program implementation will be evaluated through survey data at two time points (Wave 2 and Wave 3 of data collection), including questions to:
• students, parents/guardians, teachers about whether they attended the initial presentations
• teachers on how program lesson plans have been delivered throughout the intervention period including the number of lessons delivered and approximate frequency.
• students on their use of the Resilience journal provided as part of the program.

The semi-structured interviews and focus group discussions that will be held between Wave 2 and 3 with participants will include open ended questions regarding use of specific elements of the resilience program.
Intervention code [1] 314888 0
Lifestyle
Intervention code [2] 314889 0
Behaviour
Comparator / control treatment
Waitlist control. Students at control schools complete the standard Australian school curriculum including any wellbeing related initiatives already implemented at their school. They have the opportunity to implement the Resilience Project in the following school year should they choose to do so.
Control group
Active

Outcomes
Primary outcome [1] 320586 0
Attitudes towards gratitude in children, from mean score on Gratitude Questionnaire-6 (McCullough, Emmons & Tsang, 2002), and self-reported frequency of gratitude reflection, measured by survey question designed for the study.
Timepoint [1] 320586 0
Wave1; 1 month after delivery of program presentation to students (Wave 2); and 6 months after commencement of program curriculum in classrooms (Wave 3- primary timepoint).
Primary outcome [2] 320587 0
Self-reported frequency of acts of kindness, measured by two survey questions designed for the study.
Timepoint [2] 320587 0
Wave 1; 1 month after delivery of program presentation to students (Wave 2); and 6 months after commencement of program curriculum in classrooms (Wave 3- primary timepoint).
Primary outcome [3] 320588 0
Self-reported frequency of use of mindfulness, measured by two survey questions designed for the study.
Timepoint [3] 320588 0
Wave 1; 1 month after delivery of program presentation to students (Wave 2); and 6 months after commencement of program curriculum in classrooms (Wave 3- primary timepoint).
Secondary outcome [1] 372119 0
Positive and negative affect in children as measured by the Positive and Negative Affect Scale for Children
Timepoint [1] 372119 0
Wave 1; 1 month after delivery of program presentation to students (Wave 2); and 6 months after commencement of program curriculum in classrooms (Wave 3).
Secondary outcome [2] 372120 0
Emotion Expression in children as measured by Emotion Expression Scale for Children
Timepoint [2] 372120 0
Wave 1; 1 month after delivery of program presentation to students (Wave 2); and 6 months after commencement of program curriculum in classrooms (Wave 3).
Secondary outcome [3] 372121 0
Resilience in children as measured by Child and Youth Resilience Measure
Timepoint [3] 372121 0
Baseline; 1 month after delivery of program presentation to students (Wave 2); and 6 months after commencement of program curriculum in classrooms (Wave 3).
Secondary outcome [4] 372122 0
Qualitative data on perceptions and experiences of staff, students and parents, collected via interviews, focus groups, and student case studies. This is an exploratory outcome.
Timepoint [4] 372122 0
4-6 months after commencement of program curriculum in classrooms

Eligibility
Key inclusion criteria
All students in grade 4 to 6, attending one of twelve (6 intervention, 6 comparison) pre-determined primary schools in Victoria.
All parents of students in grade 4 to 6 attending one of twelve (6 intervention, 6 comparison) pre-determined primary schools in Victoria.
All teaching staff of students in grade 4 to 6 working at one of twelve (6 intervention, 6 comparison) pre-determined primary schools in Victoria.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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



Intervention assignment
Parallel
Other design features
One group of participants receive the same intervention (standard school curriculum plus the Resilience Project) for the entire study, the comparison group receives the standard school curriculum with no intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study will be conducted as an exploratory trial to allow the intervention to be refined, acceptability and uptake tested, and evaluation methods and measures to be assessed. This will include an assessment of impact for the primary outcomes and for the secondary outcomes relating to attitudes, to establish a likely effect size for future randomised trials. The evaluation will also include examination of participant experience and process evaluation components; and additional secondary outcomes, not powered to detect significant differences, including adult behaviour and attitude changes, and changes in child resilience. As this is an exploratory trial, no adjustments will be made for multiple significance tests.

Sample Size Calculation:
The sample size calculation includes allowance for school-based clustering, with a design effect of 2.38 assuming an average school size of 70 pupils and intra-class correlation (ICC) of 0.02. Average school size is calculated from estimated student populations in grades 4, 5 and 6 of the 12 included schools, with initial recruitment of 40% of students and attrition to Wave 3 of 10%. Recruitment and attrition rates are assumed from previous school-based research work conducted by the same University of Melbourne research team. The ICC is estimated from previous Australian school-based intervention research (Calear, A.L., Christensen, H., Mackinnon, A., Griffiths, K.M., & O’Kearney, R. (2009). The YouthMood Project: a cluster randomized controlled trial of an online cognitive behavioural program with adolescents. Journal of Consulting and Clinical Psychology, 77, p. 1021-1032).
Sample size calculations are based on an effect size of 0.29 (based similar interventions targeting gratitude in 8-11-year-old school students; Froh, J.J. et al. (2014). Nice Thinking! An educational intervention that teaches children to think gratefully. School Psychology Review, 43(2), p. 132-152), with power set at 0.8, two-tailed alpha of 0.05, with independent means and equal group size between control and interventions. This produces a total target sample size of 895 students, or 448 per condition.

Primary quantitative analysis:
Overall effects of primary and secondary outcomes will be analysed using mixed-model repeated measures, including random effects for school to accommodate potential clustering effects and treating the outcome measures as continuous variables. Each outcome will be assessed with a contract measure change in the outcome variable from Baseline to Wave 3, comparing between the intervention and comparison schools. Mixed effects models will also be used to test mediators of outcomes, including exposure to the intervention based on student, parent, and teacher process evaluation data, baseline measures of negative affect on the PANAS-C for students, and parent and teacher data on the use of gratitude, kindness, and mindfulness strategies across the three waves. Other demographics variables such as student gender, age, and SES based on postcode may be explored as covariates.

Qualitative analysis:
Qualitative records of interviews and focus groups will be analysed using inductive thematic analyses informed by a grounded theory approach to enable unanticipated themes to emerge and to develop an in-depth understanding of how the program is experienced by the different stakeholders within the school communities. Findings from high impact student case studies will also be used to develop anonymous composite case scenarios to represent the nature and circumstances of students likely to benefit most from the program to investigate the targeted versus universal benefits of the program.
For each survey item asking for a word to describe the program, a wordle will be produced (www.wordle.net), and frequency of words will be described. Any free text comments on the surveys from all participants will be analysed with qualitative thematic analysis as for the main qualitative analysis.

Secondary analysis:
If the primary analyses show effects in primary and secondary outcomes for students, secondary analyses will be conducted using Qualitative Comparative Analysis to investigate which aspects of the RP program contribute to improvements of student wellbeing outcomes of emotional expression and resilience. Factors included in this analysis will be student, parent, and teacher participation in the program, baseline affect measured by the PANAS, and uptake of the three types of strategies in the program (gratitude, kindness, and mindfulness).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
20/02/2019
Date of last participant enrolment
Anticipated
Actual
10/06/2019
Date of last data collection
Anticipated
20/12/2019
Actual
Sample size
Target
895
Accrual to date
Final
1020
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302637 0
Other Collaborative groups
Name [1] 302637 0
The Resilience Project
Country [1] 302637 0
Australia
Primary sponsor type
University
Name
Professor Lisa Gibbs
Address
Centre for Health Equity, Melbourne School of Population and Global Health
University of Melbourne Level 5, 207 Bouverie Street, Carlton, VIC 3053
Country
Australia
Secondary sponsor category [1] 303174 0
None
Name [1] 303174 0
Address [1] 303174 0
Country [1] 303174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303263 0
University of Melbourne, Medicine and Dentistry Human Ethics Sub-Committee
Ethics committee address [1] 303263 0
Ethics committee country [1] 303263 0
Australia
Date submitted for ethics approval [1] 303263 0
10/11/2018
Approval date [1] 303263 0
07/12/2018
Ethics approval number [1] 303263 0
1853222
Ethics committee name [2] 303730 0
Department of Education and Training
Ethics committee address [2] 303730 0
Ethics committee country [2] 303730 0
Australia
Date submitted for ethics approval [2] 303730 0
06/12/2018
Approval date [2] 303730 0
22/01/2019
Ethics approval number [2] 303730 0
2018_003909
Ethics committee name [3] 303731 0
Catholic Education Melbourne
Ethics committee address [3] 303731 0
Ethics committee country [3] 303731 0
Australia
Date submitted for ethics approval [3] 303731 0
11/12/2018
Approval date [3] 303731 0
01/02/2019
Ethics approval number [3] 303731 0
0842

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

Contacts
Principal investigator
Name 93058 0
Prof Lisa Gibbs
Address 93058 0
Centre for Health Equity, Melbourne School of Population and Global Health
University of Melbourne Level 5, 207 Bouverie Street, Carlton, VIC 3053
Country 93058 0
Australia
Phone 93058 0
+61 3 8344 0920
Fax 93058 0
Email 93058 0
[email protected]
Contact person for public queries
Name 93059 0
Lauren Carpentar
Address 93059 0
Centre for Health Equity, Melbourne School of Population and Global Health
University of Melbourne
Level 5 207 Bouverie Street, Carlton, VIC 3053
Country 93059 0
Australia
Phone 93059 0
+61 383440903
Fax 93059 0
Email 93059 0
[email protected]
Contact person for scientific queries
Name 93060 0
Lisa Gibbs
Address 93060 0
Centre for Health Equity, Melbourne School of Population and Global Health
University of Melbourne Level 5, 207 Bouverie Street, Carlton, VIC 3053
Country 93060 0
Australia
Phone 93060 0
+61 3 8344 0920
Fax 93060 0
Email 93060 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
The relevant ethics committees did not provide approval for sharing of individual participant data. As the data collected relates to personal child wellbeing and mental health, the research team agreed to maintain strict confidentiality and not seek to make the data publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2653Ethical approval    377500-(Uploaded-28-06-2019-16-06-33)-Study-related document.pdf



Results publications and other study-related documents

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