Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001287527
Ethics application status
Approved
Date submitted
4/10/2024
Date registered
23/10/2024
Date last updated
23/10/2024
Date data sharing statement initially provided
23/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Resilience and wellbeing in the era of climate change: an acceptability and feasibility pilot of the Bee Well program for treating eco-anxiety in rural children exposed to natural hazards
Scientific title
The acceptability, feasibility, and clinical utility of the Bee Well program for treating eco-anxiety in rural children exposed to natural hazards
Secondary ID [1] 313079 0
None
Universal Trial Number (UTN)
U1111-1313-8950
Trial acronym
Bee Well
Linked study record

Health condition
Health condition(s) or problem(s) studied:
climate change anxiety 335319 0
Condition category
Condition code
Mental Health 331893 331893 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a single day workshop, conducted face-to-face in a natural environment outdoors. The workshop will run for a duration of approximately 6 hours and each participant will only attend the workshop once. The intervention will be delivered in a group setting, with 10-12 participants receiving the intervention together and concurrently. The workshop will be delivered by registered Clinical Psychologists. The intervention will be conducted through interactive activities that include psycho-education and guided-interactive discussions on eco-emotions, coping, and resilience, a group nature restoration project building a bee hive, guided mindfulness meditation, and brainstorming self-care strategies such as taking a break from climate news. The manualised intervention comprises 5 inter-related and consecutive modules; 1) finding common ground, 2) taking action together, 3) coping, 4) cultivating resilience, 5) bringing it together. The manual for this intervention was specifically designed for this trial and is available publically https://www.une.edu.au/about-une/faculty-of-medicine-and-health/school-of-psychology/research/psychosocial-health-and-wellbeing-focussing-on-rural-communities/bee-well-project. The Clinical Psychologists who developed the treatment manual are responsible for delivering the intervention. Adherence of participants to the treatment will be recorded as the number of modules completed (0 to 5).


Intervention code [1] 329636 0
Treatment: Other
Comparator / control treatment
No control group. Single-group design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339508 0
Change in psychological distress from pre to post-intervention
Timepoint [1] 339508 0
Baseline (1 week pre-intervention) and immediately post-intervention (end of treatment)
Secondary outcome [1] 440248 0
Change in resilience from pre to post-intervention
Timepoint [1] 440248 0
Baseline (1 week pre-intervention) and immediately post-intervention (end of treatment)
Secondary outcome [2] 440443 0
Change in climate change worry from pre to post-intervention
Timepoint [2] 440443 0
Baseline (1 week pre-intervention) and immediately post-intervention (end of treatment)
Secondary outcome [3] 440444 0
Change in climate change emotions from pre to post-intervention
Timepoint [3] 440444 0
Baseline (1 week pre-intervention) and immediately post-intervention (end of treatment)

Eligibility
Key inclusion criteria
Persons age 10-14 years;
Living in a rural area, defined as Modified Monash Model 3 or higher;
Self-reported exposure to one or more natural hazards, including any bushfire, flood, tornado, or drought.
Minimum age
10 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any medical or psychological condition prohibiting participation in a six hour interactive workshop ascertained by clinical judgement.

Study design
Purpose of the study
Treatment
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
This project pilots an intervention, generally precluding definitive sample size calculation. It has been argued that, for clinical intervention pilots, a minimum of 10 persons completing in the intervention group is required. In order to allow for up to 10% attrition and ensure sufficient data for preliminary efficacy testing, a minimum sample of 12 is anticipated.

The intervention's potential efficacy will be assessed by mean change from pre- to post-intervention with paired samples t-tests for continuous measures of primary outcome (DASS-Y) and secondary outcomes (RS10, climate change worry). The secondary outcome climate change emotions (e.g. sad, helpless, etc) are categorical responses, requiring a chi-square for trend analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 43252 0
2350 - Armidale

Funding & Sponsors
Funding source category [1] 317524 0
Charities/Societies/Foundations
Name [1] 317524 0
The Peregrine Centre (Rural Mental Health Small Project Grants)
Country [1] 317524 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Peregrine Centre
Address
Country
Australia
Secondary sponsor category [1] 319869 0
None
Name [1] 319869 0
Address [1] 319869 0
Country [1] 319869 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316235 0
University of New England Human Research Ethics Committee
Ethics committee address [1] 316235 0
Ethics committee country [1] 316235 0
Australia
Date submitted for ethics approval [1] 316235 0
24/05/2023
Approval date [1] 316235 0
29/08/2023
Ethics approval number [1] 316235 0
HE23-080

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

Contacts
Principal investigator
Name 137238 0
A/Prof Suzanne Cosh
Address 137238 0
School of Psychology, Elm Ave, The University of New England, Armidale NSW 2351
Country 137238 0
Australia
Phone 137238 0
+61 2 6773 2073
Fax 137238 0
Email 137238 0
scosh@une.edu.au
Contact person for public queries
Name 137239 0
Joanne Robinson
Address 137239 0
School of Psychology, Elm Ave, The University of New England, Armidale NSW 2351
Country 137239 0
Australia
Phone 137239 0
+61 2 6773 5508
Fax 137239 0
Email 137239 0
jrobin20@une.edu.au
Contact person for scientific queries
Name 137240 0
Suzanne Cosh
Address 137240 0
School of Psychology, Elm Ave, The University of New England, Armidale NSW 2351
Country 137240 0
Australia
Phone 137240 0
+61 2 6773 2073
Fax 137240 0
Email 137240 0
scosh@une.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


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.