Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000700730
Ethics application status
Approved
Date submitted
6/05/2022
Date registered
16/05/2022
Date last updated
13/04/2024
Date data sharing statement initially provided
16/05/2022
Date results information initially provided
26/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the efficacy of “Growing with Gratitude”: A community school-based program for promoting students’ resilience and well-being
Scientific title
Evaluating the efficacy of “Growing with Gratitude”: A community school-based program for promoting students’ resilience and well-being
Secondary ID [1] 307069 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression
 326226 0
Anxiety 326227 0
Well-being 326228 0
Condition category
Condition code
Mental Health 323528 323528 0 0
Depression
Mental Health 323529 323529 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The efficacy of the Growing with Gratitude program will be evaluated in Year 3, 4 and 5 classrooms. Prior to program delivery, teachers will attend a one hour training session via Zoom (recorded for those unable to attend), where they will be taught how to navigate the website, where to find lesson plans, and will have opportunity for Q&A. The program will be delivered face-to-face by teachers to students in their classroom. Teachers will use the program's online curriculum to deliver the program content. The program runs for 9-weeks, with one 30-45 minute session delivered each week, as well as three short 5-minute activities. There are five key topics in the program: An Attitude of Gratitude, Random Acts of Kindness, Positive Reflection, Well-being Warriors (mindfulness & physical activity) and Operation Home Service. The 30-45 minute lessons typically include a short video introducing the topic, classroom discussion of topics (e.g. What is gratitude?), and an engaging learning activity. One example of a learning activity is students place a sticky notes on things in the classroom they are grateful for. Short activities are found on the Daily Habits of Happiness wheel, which is an interactive online tool. Spinning the wheel results in a variety of activities, an example includes students writing down an act of kindness they have witness and placing in a box to be shared with the class. Fidelity will be measured weekly using a survey completed by teachers delivering the program.
Intervention code [1] 323524 0
Prevention
Comparator / control treatment
Teachers in the control group will deliver usual curriculum and no program to students in their classroom.
Control group
Active

Outcomes
Primary outcome [1] 331284 0
Stirling Children’s Well-being Scale
Timepoint [1] 331284 0
Baseline, mid-program, post-program and follow ups (6-months and 12-months)
Primary outcome [2] 331285 0
Revised Child Anxiety and Depression Scale – Short Version (RCADS)
Timepoint [2] 331285 0
Baseline, mid-program, post-program and follow ups (6-months and 12-months)
Secondary outcome [1] 409424 0
Child and Youth Resilience Measure (CYRM-R)
Timepoint [1] 409424 0
Baseline, mid-program, post-program and follow ups (6-months and 12-months)
Secondary outcome [2] 409425 0
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Timepoint [2] 409425 0
Baseline, mid-program, post-program and follow ups (6-months and 12-months)
Secondary outcome [3] 409426 0
The Gratitude Questionnaire-Six Item Form (GQ-6)
Timepoint [3] 409426 0
Baseline, mid-program, post-program and follow ups (6-months and 12-months)

Eligibility
Key inclusion criteria
Participants will be students in Year 3, 4 or 5
Minimum age
7 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students in other year levels are not eligible, no other exclusion criteria

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)
Person separate to research ran allocation via computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation completed by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Participants assigned either to intervention or control group
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
25 clusters (classrooms) needed per condition assuming a correlation of 0.3 between well-being at baseline and post-program, and an intraclass correlation coefficient of 0.1. This is roughly 1,250 participants total, depending on class size. Analyses will include the efficacy of the program based on whether well-being scores increases and depression/anxiety symptoms decrease between baseline and post-program, as well as evaluation of acceptability of the program by students and teachers, and examination of mechanisms involved (e.g. resilience, gratitude and emotion regulation).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/05/2022
Date of last participant enrolment
Anticipated
29/07/2022
Actual
30/07/2022
Date of last data collection
Anticipated
30/09/2023
Actual
28/09/2023
Sample size
Target
50
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 311382 0
University
Name [1] 311382 0
The University of Adelaide
Country [1] 311382 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University of Adelaide,
Adelaide, South Australia
5005 Australia
Country
Australia
Secondary sponsor category [1] 312771 0
None
Name [1] 312771 0
Address [1] 312771 0
Country [1] 312771 0
Other collaborator category [1] 282288 0
University
Name [1] 282288 0
Flinders University
Address [1] 282288 0
Sturt Rd, Bedford Park
South Australia 5042
Country [1] 282288 0
Australia
Other collaborator category [2] 282290 0
Individual
Name [2] 282290 0
Dr Michael Proeve
Address [2] 282290 0
School of Psychology, Hughes Building, The University of Adelaide,
Adelaide, South Australia
5005 Australia
Country [2] 282290 0
Australia
Other collaborator category [3] 282291 0
Individual
Name [3] 282291 0
Dr Junwen Chen
Address [3] 282291 0
Research School of Psychology
The Australian National University
Building 39
Science Road
Canberra ACT 2601
Country [3] 282291 0
Australia
Other collaborator category [4] 282292 0
Individual
Name [4] 282292 0
A/Prof Rachel Roberts
Address [4] 282292 0
School of Psychology, Hughes Building, The University of Adelaide,
Adelaide, South Australia
5005 Australia
Country [4] 282292 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310864 0
Flinders University Social and Behavioural Research Ethics Committee
Ethics committee address [1] 310864 0
Sturt Rd, Bedford Park
South Australia 5042
Ethics committee country [1] 310864 0
Australia
Date submitted for ethics approval [1] 310864 0
10/06/2019
Approval date [1] 310864 0
05/08/2019
Ethics approval number [1] 310864 0
8386

Summary
Brief summary
This trial will evaluate the efficacy of Growing with Gratitude as a preventative program, by specifically examining whether the program will: 1) increase gratitude and resilience, and 2) prevent and reduce anxiety and depression symptomology in children. Furthermore, the current trial will also aim to explore resilience, gratitude and emotion regulation as a potential mechanisms by which the program prevents negative affect such as anxiety and depression.
Trial website
Trial related presentations / publications
Public notes
Sample size refers to clusters as this trial is a cluster randomised controlled trial.

Contacts
Principal investigator
Name 119142 0
Dr Junwen Chen
Address 119142 0
Research School of Psychology
The Australian National University
Building 39
Science Road
Canberra ACT 2601
Country 119142 0
Australia
Phone 119142 0
+610261252038
Fax 119142 0
Email 119142 0
junwen.chen@anu.edu.au
Contact person for public queries
Name 119143 0
Mrs Jasmine Turner
Address 119143 0
School of Psychology, The University of Adelaide, Adelaide, South Australia
5005 Australia
Country 119143 0
Australia
Phone 119143 0
+61414501376
Fax 119143 0
Email 119143 0
jasmine.c.turner@adelaide.edu.au
Contact person for scientific queries
Name 119144 0
Mrs Jasmine Turner
Address 119144 0
School of Psychology, The University of Adelaide, Adelaide, South Australia
5005 Australia
Country 119144 0
Australia
Phone 119144 0
+61414501376
Fax 119144 0
Email 119144 0
jasmine.c.turner@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to confidential nature of the data and conditions of ethics


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.