Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000498493
Ethics application status
Approved
Date submitted
2/05/2025
Date registered
22/05/2025
Date last updated
22/05/2025
Date data sharing statement initially provided
22/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Gaawaadhi Gadudha: A stepped-wedge cluster randomised trial and evaluation of the effectiveness of an Aboriginal cultural health program
Scientific title
Gaawaadhi Gadudha: Measuring the effectivness and evaluating the implementation process of a cultural health program for Aboriginal adults in New South Wales against participant reported outcomes of cultural health and social and emotional wellbeing using a stepped-wedge cluster randomised trial design.
Secondary ID [1] 314341 0
Nil
Universal Trial Number (UTN)
U1111-1322-1529
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cultural Health 337315 0
Pyschological distress 337316 0
Depression 337471 0
Social and emotional wellbeing 337472 0
Condition category
Condition code
Public Health 333700 333700 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial program will be delivered by the Gamilaraay, Yuwaalaraay, and Yuin (Aboriginal) Senior Cultural Health Facilitators and Cultural Health Facilitators, with support from Assistant Cultural Health Facilitators in each region. Senior Cultural Health Facilitators are respected cultural knowledge holders from their respective regions, who are experienced in delivering cultural health support and care, including the provision of cultural camps on Country, teaching Aboriginal languages, transmission of cultural knowledges of plants, foods and medicines, and traditional healing modalities. Because the Senior Cultural Health Facilitators were involved in co-designing the trial program and implementation plan, training to deliver the program will not be necessary. However, a workshop with the principal coordinating investigator will be held prior to trial program commencement, to ensure the program delivery team are confident that the program’s ‘implementation plan’ is feasible and appropriate, and to clarify any potential issues before commencing.

The Cultural Health Program will be delivered over a 2-month period to each cluster (total 4 clusters). The required contact time for participants is 112 hours which includes the following components: two yarning circle sessions at the beginning and end of the program (4 hours); five Gamilaraay (Northwestern region) or Yuin-Djirringanj (Far South Coast region) language sessions (2 hours per session, held fortnightly); one cultural medicine workshop (3 hours); one cultural foods gathering (3 hours); one cultural camp on-Country (4 days/96 hours). Details for each component are below. Attendance logs will be recorded by Cultural Health Facilitators at every program activity in order to asses adherence and fidelity.

Component 1 – Yarning circle start: Program participants will attend one 2-hour yarning circle at the beginning of the program in the community settings of Tamworth (Northwestern region) or Wallaga Lake (Far South Coast region). A welcome and acknowledgement of Country, and a smoking ceremony will occur prior to the official start of the yarning circle. Yarning circles are a culturally safe and non-hierarchical way of sharing experiences that promote relationality and reciprocity. Yarning circles will be facilitated by a Senior Cultural Health Facilitator or Cultural Health Facilitator, and will be gender-separated to observe cultural norms. Yarning circles will provide an opportunity for participants to be acquainted collectively, and for Cultural Health Facilitators to provide further clarification and depth on the program. Following this, Cultural Health Facilitators will use a yarning circle guide to encourage participants to share information about their cultural journey and aspirations, their cultural health needs, challenges moving forward in life, and expectations for the program. Yarning circles will be audio recorded and transcribed.

Component 2 – Language course: Program participants will attend five language sessions (2 hours per session) which will occur on a mostly fortnightly basis in the community settings of Tamworth (Northwestern region) or Wallaga Lake (Far South Coast region). Language sessions will be delivered by a Language Educator and a Senior Cultural Health Facilitator and aim to equip participants with basic Gamilaraay (Northwestern region), or Yuin-Djirringanj (Far South Coast region) language competency. Each session will emphasise the importance of language in cultural connection, practice and identity. Aboriginal language competency is strongly associated with strength and pride in cultural identity, both of which are protective factors to Social and Emotional Wellbeing (SEWB). Language sessions will not cover gender-sensitive topics, and therefore it is deemed culturally appropriate to deliver them to male and female participants together in the one group. The language course will be delivered using the Language Course Outline. A brief description of structure is included below:
Session 1: Introduction, program expectations, alphabet and pronunciation, terminology, generic words, phrases, and sounds, basic greetings, learn how to introduce yourself, activities.
Session 2: Session 1 recap, receiving work booklet, addressing family, verbs/nouns/adjectives, suffixes and conjunctions, game, common phrase activity
Session 3: Session 2 recap, learning on Country and place names, weapons and tools, food names
Session 4: Session 3 recap, body parts, mammals, birds, activity
Session 5: Session 4 recap, walk and talk on Country, reptiles, insects, marine life, creative writing activity, reflection, discuss use of language beyond program.

Component 3 – Cultural medicines workshop: Program participants will attend one traditional medicine workshop (3 hours) in the community settings of Tamworth (Northwestern region) or Wallaga Lake (Far South Coast region). The cultural medicines workshop will be delivered by a Cultural Health Facilitator and aim to equip participants with knowledge of at least three key Gamilaraay (Northwestern region), or Yuin-Djirringanj (Far South Coast region) plant-based or animal-based medicines. Participants will be shown the unprocessed medicine (e.g. plant leaves or bark) and be encouraged to learn to identify each using sensory learning (see, touch, smell). They will then be given the processed version (e.g. brewed plant tea) to try, and be provided with knowledge on what each medicine is used for. A yarning circle about the importance of cultural medicines will follow, giving participants an opportunity to ask questions. Cultural medicine knowledge and the ability to share this intergenerationally is strongly associated with a sense of healing and pride in identity, both of which are protective factors to SEWB. Cultural medicine workshop will not cover gender-sensitive topics, and therefore it is deemed culturally appropriate to be delivered to male and female participants together in the one group.

Component 4 – Cultural foods gathering: Program participants will attend one cultural foods gathering (3 hours) in the community settings of Tamworth (Northwestern region) or Wallaga Lake (Far South Coast region). The cultural foods gathering will be delivered by a Cultural Health Facilitator and aim to equip participants with knowledge of at least three key Gamilaraay (Northwestern region), or Yuin-Djirringanj (Far South Coast region) plant-based or animal-based foods. Participants will be shown how to prepare and cook cultural foods and be given the opportunity to try them. Cultural Health Facilitators will share knowledges on the medicinal properties of cultural foods. A yarning circle about the importance of cultural foods will follow, giving participants an opportunity to ask questions. Cultural food knowledge and the ability to share this intergenerationally is strongly associated with a sense of healing and pride in identity, both of which are protective factors to SEWB. Cultural food gathering will not cover gender-sensitive topics, and therefore it is deemed culturally appropriate to be delivered to male and female participants together in the one group.

Component 5 – Cultural camp on Country: Program participants will attend one cultural camp that will be held in a cultural landscape (e.g. a landscape minimally impacted by colonisation) ‘on-Country’ in each region, facilitated by two Cultural Health Facilitators who hold knowledge of that Country. In the Northwestern region, the cultural camp location will be held at Narran Lakes. In the Far South Coast region, the cultural camp will be held near Gulaga National Park. The cultural camp will run for 4 days, allowing 2 days for travel to the location and set up/pack down. The cultural camp will observe gender-separated cultural norms, having separate men’s and women’s camp sites within the one camp. All food, equipment and travel will be provided for program participants. Cultural camps delivered by cultural knowledge holders of that Country are evidenced to positively impact indicators of cultural health, support healing, and provide stress relief. They do so by offering sensory experiences in a ‘natural’ environment and facilitating the learning and sharing of cultural knowledges and language, as well as engagement in cultural practices.9,10 The cultural camp combines elements of all other program components and delivers them in a culturally-safe setting on-Country. Some camp activities will be gender-separated and some combined, observing cultural norms, with a focus on cultural knowledge transmission, connection to Country, and learning and engaging in cultural practices (such as weaving, woodwork, fire yarning). A brief agenda of the cultural camp is as follows:

Day 1: Travel 1/2 day, set up, welcome & smoking ceremony, fire yarn
Day 2: Morning - Breakfast; cultural site visit & traditional story; Afternoon - Lunch at camp; weaving (women), woodwork (men); Evening: Fire yarns
Day 3: Morning - Breakfast; cultural site visit & traditional story; Afternoon - Lunch at camp; weaving (women), woodwork (men); Evening: Fire yarns
Day 4: Morning - Reflections; smoking ceremony & thank you, travel home.

Component 6 – Yarning circle finish: Program participants will attend one 2-hour yarning circle at the completion of all other program components. Yarning circles will be facilitated by a Cultural Health Facilitator, and will be gender-separated to observe cultural norms. Cultural Health Facilitators will use a yarning circle guide to prompt participants to share reflections of the program, and if and how it contributed to their sense of cultural health, healing and wellbeing, and how they might integrate their experiences and knowledge gained from the program into their daily lives. Yarning circles will be audio recorded and transcribed.
Intervention code [1] 330951 0
Treatment: Other
Comparator / control treatment
Due to the stepped-wedge cluster controlled trial design, all participants receive the program at different time points. The program will be delivered to each cluster in a staggered form, with clusters yet to receive the program serving as the control group. Survey data for all participants is collected at baseline, and then at the completion of the program within each cluster, allowing for comparison of program intervention and control data.
Control group
Active

Outcomes
Primary outcome [1] 341295 0
Cultural Health Measure: Importance of cultural health to personal sense of health and wellbeing
Timepoint [1] 341295 0
The stepped-wedge design requires all participants to be assessed at baseline then at 2 months, 4 months, 6 months, 8 months, and 10 months (2 month follow up), to allow for clusters yet to receive the program to act as control groups. The primary analysis will include data from all timepoints, both pre- and post- program delivery, to estimate the average treatment effect. However the primary ‘endpoint’ will be the timepoint immediate post-program completion for each cluster .
Primary outcome [2] 341448 0
Cultural Health Measure: Cultural knowledge
Timepoint [2] 341448 0
The stepped-wedge design requires all participants to be assessed at baseline then at 2 months, 4 months, 6 months, 8 months, and 10 months (2 month follow up), to allow for clusters yet to receive the program to act as control groups. The primary analysis will include data from all timepoints, both pre- and post- program delivery, to estimate the average treatment effect. However the primary ‘endpoint’ will be the timepoint immediate post-program completion for each cluster .
Primary outcome [3] 341449 0
Cultural Health Measure: Time spent practicing culture
Timepoint [3] 341449 0
The stepped-wedge design requires all participants to be assessed at baseline then at 2 months, 4 months, 6 months, 8 months, and 10 months (2 month follow up), to allow for clusters yet to receive the program to act as control groups. The primary analysis will include data from all timepoints, both pre- and post- program delivery, to estimate the average treatment effect. However the primary ‘endpoint’ will be the timepoint immediate post-program completion for each cluster .
Secondary outcome [1] 447040 0
Psychological distress
Timepoint [1] 447040 0
The stepped-wedge design requires all participants to be assessed at baseline then at 2 months, 4 months, 6 months, 8 months, and 10 months (2 month follow up), to allow for clusters yet to receive the program to act as control groups. Analysis of secondary outcomes will include data from all timepoints, both pre- and post- program delivery, to estimate the average treatment effect.
Secondary outcome [2] 447543 0
Depression
Timepoint [2] 447543 0
The stepped-wedge design requires all participants to be assessed at baseline then at 2 months, 4 months, 6 months, 8 months, and 10 months (2 month follow up), to allow for clusters yet to receive the program to act as control groups. Analysis of secondary outcomes will include data from all timepoints, both pre- and post- program delivery, to estimate the average treatment effect.
Secondary outcome [3] 447544 0
Emotional empowerment
Timepoint [3] 447544 0
The stepped-wedge design requires all participants to be assessed at baseline then at 2 months, 4 months, 6 months, 8 months, and 10 months (2 month follow up), to allow for clusters yet to receive the program to act as control groups. Analysis of secondary outcomes will include data from all timepoints, both pre- and post- program delivery, to estimate the average treatment effect.
Secondary outcome [4] 447545 0
Emotional empowerment
Timepoint [4] 447545 0
The stepped-wedge design requires all participants to be assessed at baseline then at 2 months, 4 months, 6 months, 8 months, and 10 months (2 month follow up), to allow for clusters yet to receive the program to act as control groups. Analysis of secondary outcomes will include data from all timepoints, both pre- and post- program delivery, to estimate the average treatment effect.

Eligibility
Key inclusion criteria
• 18 years of age or older
• living in the study region with confirmation of address
• able to communicate in English
• self-identified motivation to increase connection to culture and Country
• agree and can commit to attending 112 hours of program activities over a 2-month period in community and on-Country (land-based cultural locations outside of community) settings
• capable of providing informed consent at initial recruitment and answering baseline questions (successfully completing at least 75% of baseline questions).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• They do not identify as Aboriginal and/or Torres Strait Islander

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
Randomisation at regional level
Clusters will be randomised to receive the program at 2-month intervals. A maximum period of 2 months may occur between each cluster to account for calendar events that may impact optimal program participation (e.g. Christmas period and school holidays). Due to some trial program activities taking place in on-Country settings (e.g. outdoor camping), the time of year in which these activities occur must consider regional weather patterns. For example, in the Northwestern NSW study sites it is not appropriate to do outdoor camping activities between the months of October-March as the temperature can reach up to 50 degrees Celsius. For this reason, the project must take a pragmatic approach to randomisation. In doing so, the project will use a randomisation matrix which blocks out the possibility of the Northwestern NSW study sites delivering the program during October-March.

Randomisation at cluster level
After eligibility screening has taken place, and full consent has been received, each participant will be randomly allocated to one of two program clusters in their respective regions (total of 4 clusters in the study). A random number generator will choose between the numbers 1 and 2, to determine whether the first (1) or second (2) of the sites in each region is allocated to the program first. Randomisation will be conducted by a member of the research team who will document these results in an electronic document, which will be returned to the Coordinating Principal Investigator, who will archive this documentation prior to unblinding the site list and informing Cultural Health Facilitators of the allocation. Sites will be provided with the resources and research team services associated with their allocated condition during the 2-month program implementation periods, before swapping to the alternative condition in for the remainder of the study period. Sites will be informed of the importance of maintaining a consistent approach to screening and recruitment and minimising the sharing of information about the program or active control status of the study site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
All participants receive the program at different time points. The program will be delivered to each of the 4 clusters in a staggered form, with clusters yet to receive the program serving as the control group. Primary and secondary outcomes are assessed at baseline, at program completion for each cluster (every 8 weeks), and at follow up (10 months after baseline).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2025
Actual
Date of last participant enrolment
Anticipated
4/07/2025
Actual
Date of last data collection
Anticipated
3/07/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318860 0
Government body
Name [1] 318860 0
Australian Government Department of Health and Aged Care, Medical Research Future Fund
Country [1] 318860 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 321328 0
None
Name [1] 321328 0
Address [1] 321328 0
Country [1] 321328 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317476 0
Aboriginal Health & Medical Research Council Ethics Committee
Ethics committee address [1] 317476 0
Ethics committee country [1] 317476 0
Australia
Date submitted for ethics approval [1] 317476 0
Approval date [1] 317476 0
22/04/2025
Ethics approval number [1] 317476 0
2257/24

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

Contacts
Principal investigator
Name 141170 0
Dr Aryati Yashadhana
Address 141170 0
Level 3, Samuels Building, UNSW, NSW, 2052
Country 141170 0
Australia
Phone 141170 0
+61 02 90650108
Fax 141170 0
Email 141170 0
[email protected]
Contact person for public queries
Name 141171 0
Aryati Yashadhana
Address 141171 0
Level 3, Samuels Building, UNSW, NSW, 2052
Country 141171 0
Australia
Phone 141171 0
+61 02 90650108
Fax 141171 0
Email 141171 0
[email protected]
Contact person for scientific queries
Name 141172 0
Aryati Yashadhana
Address 141172 0
Level 3, Samuels Building, UNSW, NSW, 2052
Country 141172 0
Australia
Phone 141172 0
+61 02 90650108
Fax 141172 0
Email 141172 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24689Ethical approval    GG2_AHMRC Ethics approval letter_APRIL 2025.pdf
24755Ethical approval    GG2_AHMRC Ethics approval letter_MAY 2025.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.