Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001071516
Ethics application status
Approved
Date submitted
8/07/2024
Date registered
4/09/2024
Date last updated
4/09/2024
Date data sharing statement initially provided
4/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
GROW SHARE: Social prescribing of permaculture for adults with mental illness
Scientific title
Evaluate the change in quality of life through social prescribing of permaculture for adults living with a mental health condition
Secondary ID [1] 312460 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 334324 0
Condition category
Condition code
Mental Health 330982 330982 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
‘GROW SHARE’ is a new social prescribing Permaculture program for adults with mental illness. The key objectives of the ‘GROW SHARE’ permaculture program are to 1. To improve Quality of Life (QoL) (including perceptions of overall health, psychological distress levels, loneliness and recovery) - through engagement in activities of contribution, promoting goals and purpose, social connection and belonging; 2. To develop permaculture specific and transferable skills, increasing vocational readiness and opportunities to continue formal training; 3. To build confidence in participants to use and share developed skills building capacity and paying it forward to their communities.

GROW SHARE consists of eight 2–3-hour face-to-face sessions. Each session will consist of four to ten adults living with mental illness. Participants will be required to complete eight sessions but will have the flexibility to complete these sessions over a 12-week period to account for missed sessions due to acute illness, fluctuations in well-being, prior commitments, or adverse weather. Each session will have three phases: (1) Opening circle including Acknowledgment of country and group member introductions, (2) Permaculture activity in the garden, (3) Group cup of tea and snack (using fresh grown ingredients). The sessions will be underpinned by the ethics and principles of permaculture and guided by themes of water, nutrient cycling, life of the soil, preparing to plant, seeds, microclimates, and structures, harvesting, maximising nutrition, connection to land, community and self. Participants will be taught permaculture specific skills including system design, observing and interacting with nature, soil care, plant care, organic gardening, self-sufficiency, water management, harvesting, food preservation, and resource management. Through GROW SHARE participants will develop transferable skills including systems thinking, observation and awareness, resourcefulness, leadership, collaboration and communication, social, critical thinking, creative problem solving, innovation, adaptability, and ethical decision-making skills. Participants will be offered the ability to be assessed on their learning to gain credit towards a TAFE Certificate 1 in Permaculture. GROW SHARE will be taught by a permaculture teacher employed by Primary & Community Care Services to deliver the program.

Session attendance will be collected. Adults with mental illness will contribute to the study by providing pre, post and 12 months post surveys using validated outcome measures and single item measures. Individual realist interviews using photo elicitation will be conducted post completing the intervention and 12 month post program interviews will be conducted individually. To identify the contexts, mechanisms, intended and unintended outcomes of the program from multiple perspectives (Adults with mental illness, Primary and Community Care Services managers, link workers and facilitators, and a nominated family carer of the participant) will be measured by interviews, group interviews and facilitator reflection notes.

Intervention code [1] 328994 0
Lifestyle
Intervention code [2] 329237 0
Treatment: Other
Comparator / control treatment
No control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338743 0
Quality of Life
Timepoint [1] 338743 0
Pre intervention, post intervention (approx 12 weeks), & 12 months post completion of program
Primary outcome [2] 339053 0
Health
Timepoint [2] 339053 0
Pre intervention, post intervention (approx 12 weeks), & 12 months post completion of program
Primary outcome [3] 339054 0
Symptoms of mental illness [mild, moderate, severe]
Timepoint [3] 339054 0
Pre intervention, post intervention (approx 12 weeks), & 12 months post completion of program
Secondary outcome [1] 437264 0
To assess what extent ‘GROW SHARE’ impacts permaculture knowledge and skills
Timepoint [1] 437264 0
Pre intervention, post intervention (approx 12 weeks), & 12 months post completion of program
Secondary outcome [2] 438399 0
Loneliness
Timepoint [2] 438399 0
Pre intervention, post intervention (approx 12 weeks), & 12 months post completion of program
Secondary outcome [3] 438400 0
Recovery
Timepoint [3] 438400 0
Pre intervention, post intervention (approx 12 weeks), & 12 months post completion of program
Secondary outcome [4] 438415 0
Semi-structured interviews
Timepoint [4] 438415 0
Interviews at 12 months post program
Secondary outcome [5] 438416 0
Group interviews (individual interviews offered to those who would prefer)
Timepoint [5] 438416 0
Pre and 12 months post group interviews. Interviewees will also be offered individual interviews
Secondary outcome [6] 438417 0
Facilitatior reflection notes
Timepoint [6] 438417 0
After each GROW SHARE session
Secondary outcome [7] 438418 0
Number of GROW SHARE sessions held
Timepoint [7] 438418 0
Collected during program
Secondary outcome [8] 438858 0
Participation numbers per session
Timepoint [8] 438858 0
During the program
Secondary outcome [9] 438859 0
Number of sessions attended by individual participants, and number of weeks taken to complete program as a composite outcome
Timepoint [9] 438859 0
Post completion of the program
Secondary outcome [10] 438860 0
Number of enrolments in formal education
Timepoint [10] 438860 0
12 months post completion of the program
Secondary outcome [11] 438861 0
Percentage of employment gained
Timepoint [11] 438861 0
12 months post completion of the program

Eligibility
Key inclusion criteria
Group 1- Adults with mental illness
Group 1 participants will be adults living in the Gold Coast community with ongoing mental illness. Participants will be care-coordination clients of Primary & Community Care Services, a not-for profit organisation that specialises in Social Prescribing programs in Australia. Primary & Community Care Services has a steady flow of new care-coordination clients (who are referred by their GP), and who if eligible for ‘GROW SHARE’ will be offered the opportunity to be involved in the program evaluation.

Inclusion criteria will include clients over 18 years old who speak English, living in the community, and diagnosed with a moderate to severe mental illness likely to last six months or longer.

Group 2 participants will include Primary & Community Care Services stakeholders (program developers and managers, ‘GROW SHARE’ facilitators and Link Workers) and the nominated family carer.

Inclusion criteria will include
• program developers and managers, ‘GROW SHARE’ facilitators and Link Workers employed at Primary & Community Care Services
• nominated family carers over 18 years old and who speak English. Nominated family carers will be excluded if they are receiving acute mental health inpatient treatment or have a significant cognitive impairment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients will be excluded if they are receiving acute inpatient treatment, have thoughts of harm to themselves or others, or have a significant cognitive impairment.

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)
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For continuous/ratio variables, if the data is normally distributed, paired t-test will be used. If the data is not normally distributed, the Wilcoxon’s signed rank test will be used.

Qualitative data from participant and group interviews and facilitator reflection notes will be analysed independently then brought together using six-step thematic analysis (Braun & Clarke, 2006).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316875 0
Charities/Societies/Foundations
Name [1] 316875 0
Primary & Community Care Services
Country [1] 316875 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Primary & Community Care Services
Address
Country
Australia
Secondary sponsor category [1] 319119 0
None
Name [1] 319119 0
Address [1] 319119 0
Country [1] 319119 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315635 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 315635 0
Ethics committee country [1] 315635 0
Australia
Date submitted for ethics approval [1] 315635 0
Approval date [1] 315635 0
20/05/2024
Ethics approval number [1] 315635 0
2024/049

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

Contacts
Principal investigator
Name 135334 0
A/Prof Christina Aggar
Address 135334 0
Southern Cross University, Gold Coast Campus, Southern Cross Drive, Bilinga Qld, 4225
Country 135334 0
Australia
Phone 135334 0
+61 414754705
Fax 135334 0
Email 135334 0
[email protected]
Contact person for public queries
Name 135335 0
Cassandra Tognarini
Address 135335 0
Southern Cross University, Gold Coast Campus, Southern Cross Drive, Bilinga Qld, 4225
Country 135335 0
Australia
Phone 135335 0
+61 402583329
Fax 135335 0
Email 135335 0
[email protected]
Contact person for scientific queries
Name 135336 0
Cassandra Tognarini
Address 135336 0
Southern Cross University, Gold Coast Campus, Southern Cross Drive, Bilinga Qld, 4225
Country 135336 0
Australia
Phone 135336 0
+61 402583329
Fax 135336 0
Email 135336 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.