Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000208707
Ethics application status
Approved
Date submitted
19/11/2021
Date registered
7/02/2022
Date last updated
7/02/2022
Date data sharing statement initially provided
7/02/2022
Date results provided
7/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Journey of Hope evaluation: a mixed methods evaluation examining how the program influenced the emotional and interpersonal wellbeing of primary and secondary students
Scientific title
Journey of Hope evaluation: a mixed methods evaluation with a stepped-wedge cluster-non-randomised trial, examining how the Journey of Hope program influenced the emotional and interpersonal wellbeing of primary and secondary students
Secondary ID [1] 305651 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma exposure 324208 0
Emotional resilience 324648 0
Condition category
Condition code
Mental Health 321692 321692 0 0
Anxiety
Mental Health 321694 321694 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 321695 321695 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Journey of Hope is a school-based, group work intervention for children and early adolescents who have experienced a collective trauma, such as a natural hazard or disaster. It was created in New Orleans, United States, in response to children experiencing ongoing stress from Hurricane Katrina (Powell and Blanchet-Cohen 2014). The program is delivered by two trained facilitators working with a group of 8-10 students in one-hour sessions, during school hours once a week for eight weeks. The facilitators help children develop coping skills through structured games, stories and creative play in safe, small groups. The program is designed to support children in normalising emotions associated with a community trauma while developing positive coping strategies. The program is delivered in modules that have been tailored to developmental ages.

Each session follows a similar routine to promote normalcy for students whilst also creating an emotionally safe place, using developmentally appropriate learning strategies, which include:
• Books and dialogue to introduce knowledge, reinforce messages and promote the development of children’s literacy and critical thinking skills
• Cooperative games to encourage (in a non-competitive manner) teamwork, social skills and awareness of stressors
• Art, dance and other forms of movement to give children an opportunity to learn through
alternative methods and to provide a creative outlet for expression.
The program’s design and delivery approach are grounded in cognitive-behavioural theory, to support social and psychological wellbeing for children after a traumatic experience (Duncan and Arnston 2004).

The program is delivered in modules that have been tailored to developmental ages. The modules developed include:
• Early Years – Preschool
• Early Primary – Year Prep to Year 2
• Upper Primary – Year 3 to 6
• Early High – Year 7 to 9
• Upper High – Year 10 to 12
• Caregivers – Parents and caregivers

The modules for younger participants, such as those in upper primary school years include more creative forms of learning, as well as more reading and conversations to help develop their literacy skills. In comparison, modules for older participants such as those in early high school years, use more journaling and group discussions to explore topics. The group discussions explore themes in much more detail than the Upper Primary module. Both have role play activities but the practitioners have more/less probing questions and/or lines of exploration for each group depending on the module.

Examples of activities for the Upper Primary module include:
• Reading books and facilitating conversations to introduce knowledge and promote the development of children's literacy and critical thinking skills
• Cooperative games in a non-competitive manner to encourage teamwork, social skills, and awareness of stressors
• Art, music, dance, and other forms of movement to give children an opportunity to learn through alternative methods and to provide a creative outlet for expression

Examples of activities for the Early High module include:
• Experiential cooperative games to encourage, in a non-competitive manner, teamwork, social skills, and ability to be aware of stressors
• Discussions between students and practitioners to share knowledge and strategies on effective coping strategies
• Journaling to promote self exploration and written account of feelings that participants may not feel comfortable discussing in group

All children in each group receive the same intervention, and no homework is assigned to participants. Attendance was taken for all participants, and from time to time a senior staff member (not a facilitator) conducted fidelity checks of sessions.
Intervention code [1] 322048 0
Prevention
Intervention code [2] 322049 0
Lifestyle
Intervention code [3] 322050 0
Behaviour
Comparator / control treatment
As a part of the stepped wedge design of this evaluation, two clusters of schools received the intervention - one in Term 4, 2020 and the other in Term 1, 2021. Each cluster were assigned a baseline period of one week where they are not exposed to the intervention. Following this, they then receive the intervention for a period of eight weeks. Allocation for this non-randomised stepped wedge trial was determined based on school availability.
Control group
Active

Outcomes
Primary outcome [1] 329458 0
Mean total Strengths and Difficulties Questionnaire score

The primary outcome was change in overall strengths and difficulties, measured using the Strengths and Difficulties (SDQ) scale.
Timepoint [1] 329458 0
Baseline (pre-intervention) and follow up (post-intervention - immediately post-intervention completion)
Secondary outcome [1] 402677 0
Mean Strengths and Difficulties Questionnaire prosocial subscale score

The secondary outcome was change in prosocial behaviours, measured by the SDQ prosocial subscale.
Timepoint [1] 402677 0
Baseline (pre-intervention) and follow up (post-intervention - immediately post-intervention completion)
Secondary outcome [2] 402678 0
Mean number of KIDCOPE positive and negative coping strategies

The secondary outcome was change in positive coping strategies, measured by the KIDCOPE scale; and change in capacity to recognise and manage emotional responses, measured using questions developed by Save the Children Australia with the research team.
Timepoint [2] 402678 0
Baseline (pre-intervention) and follow up (post-intervention - immediately post-intervention completion)

Eligibility
Key inclusion criteria
Students in 35 schools impacted by the Black Summer bushfires in 2019/2020, in New South Wales, if they attended grade 4-6 in primary schools and years 7-9 in secondary schools in Term 4, 2020 or Term 1, 2021 were eligible for participation. Government, religious, and independent schools were all eligible for participation.
Minimum age
8 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Special development schools were ineligible for participation.

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
Other
Other design features
This was a stepped wedge cluster non-randomised trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A mixed-methods approach was used for the evaluation, including student questionnaires (pre and post Journey of Hope program), student focus group discussions and adult (parent and teacher) interviews. A stepped wedge cluster-non-randomised study design was used for the quantitative component to accommodate the pragmatic challenges of conducting an evaluation trial in disaster affected school communities while still enabling rigorous comparison of groups receiving the program versus waiting for the program.

The quantitative component of the evaluation used a stepped-wedge cluster-non-randomised trial with 21 schools over 2 time period steps. A power calculation for the design was performed for the primary outcome measure. It was conducted with a conservative sample size estimate of 10 students from each year level (grades 3-6) of 10 primary schools (total of 400 students, 40 per primary school). Using a stepped-wedge cluster-non-randomised trial with 10 primary schools, over 2 time periods or steps (i.e. 2 intervention steps), a sample size of 40 children per school was deemed to be sufficient to detect a clinically important decrease in the primary outcome (mean SDQ total score) of 0.9 units (0.15SDs; the same effect size was used to power another similar study – see STARS cluster RCT (Ford T, et al. Psychological Medicine 2018), assuming a standard deviation of 6 units for SDQ (Mellor D, Australian Psychologist, November 2005; 40(3): 215 – 222), a within-period intra-cluster correlation (ICC) of 0.10 (Ford T, et al. Psychological Medicine 2018) and individual auto-correlation of 0.8, with 80% power and a 5% significance level. The power calculation was performed using the R Shiny CRT calculator, https://clusterrcts.shinyapps.io/rshinyapp/ (Hemming K, et al. Int J Epidemiol. 2020).

Students completed a questionnaire at the beginning of the first Journey of Hope session (pre), and then again at the end of the final Journey of Hope session (post, approximately eight weeks later). Students from a sub-sample of eight schools were invited to take part in focus groups at the end of Term 4, 2020. Teachers were asked to identify potential focus group participants with variation in age, gender and degree of engagement with the Journey of Hope program. Semi-structured telephone interviews ran for 20-60 minutes and were conducted with teachers (n=8) and parents (n=6) to explore their experiences of the Journey of Hope program and their perception of the program impacts and experiences of their students or children. Interviews were conducted by Save the Children Australia's Evaluation Team towards the end of Term 4, 2020.

Descriptive statistics were produced for all questionnaire items. The difference in the primary and secondary outcome measures before and after the program were analysed by the University of Melbourne evaluation team. The primary analysis was conducted consistent with the intention to treat principle. The primary outcome (mean total SDQ score) was analysed using linear mixed-effects models, with intervention (post versus pre-intervention) and time period (Term 4, 2020 versus Term 1, 2021) as fixed effects and school (cluster) and child as random effects. Adjustments were made for age and sex. Analyses were performed on the total sample, then stratified by program module (upper primary school, lower secondary school). All analyses were conducted in STATA SE 14 or STATA SE 16. Interviews and focus groups were inductively, thematically analysed by the Save the Children evaluation team.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/10/2020
Date of last participant enrolment
Anticipated
Actual
29/01/2021
Date of last data collection
Anticipated
Actual
1/04/2021
Sample size
Target
931
Accrual to date
Final
671
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310008 0
Charities/Societies/Foundations
Name [1] 310008 0
The LEGO Group Foundation
Country [1] 310008 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Child & Community Wellbeing Unit, Centre for Health Equity
Melbourne School of Population and Global Health
Level 5, 207 Bouverie St VIC 3010
Country
Australia
Secondary sponsor category [1] 311239 0
Charities/Societies/Foundations
Name [1] 311239 0
Save the Children Australia
Address [1] 311239 0
33 Lincoln Square South
Carlton VIC 3053
Country [1] 311239 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309718 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 309718 0
Ethics committee country [1] 309718 0
Australia
Date submitted for ethics approval [1] 309718 0
Approval date [1] 309718 0
31/08/2020
Ethics approval number [1] 309718 0
2057364
Ethics committee name [2] 309879 0
NSW Department of Education
Ethics committee address [2] 309879 0
Ethics committee country [2] 309879 0
Australia
Date submitted for ethics approval [2] 309879 0
Approval date [2] 309879 0
26/11/2020
Ethics approval number [2] 309879 0
SERAP number 2020268
Ethics committee name [3] 309880 0
Catholic Schools NSW
Ethics committee address [3] 309880 0
Ethics committee country [3] 309880 0
Australia
Date submitted for ethics approval [3] 309880 0
Approval date [3] 309880 0
03/12/2020
Ethics approval number [3] 309880 0
N/A

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

Contacts
Principal investigator
Name 115150 0
Prof Lisa Gibbs
Address 115150 0
Child & Community Wellbeing Unit, Centre for Health Equity
Melbourne School of Population and Global Health
Level 5, 207 Bouverie St, The University of Melbourne VIC 3010
Country 115150 0
Australia
Phone 115150 0
+61 3 83440920
Fax 115150 0
Email 115150 0
[email protected]
Contact person for public queries
Name 115151 0
Lisa Gibbs
Address 115151 0
Child & Community Wellbeing Unit, Centre for Health Equity
Melbourne School of Population and Global Health
Level 5, 207 Bouverie St, The University of Melbourne VIC 3010
Country 115151 0
Australia
Phone 115151 0
+61 3 83440920
Fax 115151 0
Email 115151 0
[email protected]
Contact person for scientific queries
Name 115152 0
Lisa Gibbs
Address 115152 0
Child & Community Wellbeing Unit, Centre for Health Equity
Melbourne School of Population and Global Health
Level 5, 207 Bouverie St, The University of Melbourne VIC 3010
Country 115152 0
Australia
Phone 115152 0
+61 3 83440920
Fax 115152 0
Email 115152 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.