Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000577112
Ethics application status
Approved
Date submitted
22/03/2019
Date registered
12/04/2019
Date last updated
12/04/2019
Date data sharing statement initially provided
12/04/2019
Date results provided
12/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Piloting the Skills fOr Life Adjustment and Resilience (SOLAR) program in Tuvalu
Scientific title
Investigating the acceptability, feasibility and safety of the Skills fOr Life Adjustment and Resilience (SOLAR) program with cyclone affected communities in Tuvalu
Secondary ID [1] 297408 0
Nil known
Universal Trial Number (UTN)
U1111-1228-5825
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic stress disorder (PTSD) symptoms 311569 0
Anxiety 312362 0
Depression 312363 0
Psychological distress 312364 0
Condition category
Condition code
Mental Health 310200 310200 0 0
Anxiety
Mental Health 310201 310201 0 0
Depression
Mental Health 310202 310202 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Skills fOr Life Adjustment and Resilience (SOLAR).

Description: SOLAR is a brief psychosocial intervention aimed at promoting adjustment and resilience among disaster and other trauma survivors. In this pilot SOLAR was delivered to cyclone affected individuals in a face to face, intensive group format. This entailed 5, 1 to 2 hour sessions delivered across 5 consecutive days by trained community workers (termed SOLAR coaches). Each session comprised a session overview, revision of homework tasks completed by participants, an explanation of the session topics and rationale behind their inclusion in the program, instruction and demonstration of relevant skills, opportunities to practice new skills, and setting of homework. Sessions involved a combination of psycho education by the facilitator, group discussion, group activities, partner work, and individual reflection tasks.

Coaches comprised 12 local community members who were nominated by an array of government and non-government and community organisations, with prior experience providing spiritual, practical or emotional support within their communities. Coaches received 6 days of face to face training in the SOLAR protocol by Phoenix Australia - Centre for Posttraumatic Mental Health and were provided with a SOLAR Tuvalu coach manual. They delivered the intervention in pairs to groups of up to 10 participants.

Participants were allocated to the Nui intervention group or Funafuti control group according to their place of residence. The decision to include a control period prior to the intervention period in Funafuti, rather than Nui, was made for practical reasons. Travel to Nui outer island is possible only by a 2-4 day ferry ride from Funafuti and the ferry operates according to a loose schedule subject to frequent changes. This meant we could not ensure sufficient time on Nui island to provide both conditions.

Participants were provided with a SOLAR Tuvalu participant workbook in English and/or Tuvaluan. The participant workbook included an outline of the topics covered each session, instructions of activities covered each session to enable further practice at home, and space for participants to write down reflections and questions, a plan for activities they wanted to practice, and monitoring forms to keep track of activities completed.

The SOLAR protocol was developed through an international expert collaboration led by Phoenix Australia - Centre for Posttraumatic Mental Health. The protocol was adapted for this pilot to improve cultural fit through a process involving expert review, focus group discussion, and iterative adaptation on the basis of coach feedback. Fidelity to the protocol was determined through observation of program delivery and completion of fidelity checklists by the Phoenix Australia project manager and Tuvaluan research assistants. Coaches received daily supervision.
Intervention code [1] 313657 0
Treatment: Other
Intervention code [2] 313658 0
Behaviour
Comparator / control treatment
Control treatment comprised a wait-list control period (1 week, consistent with the intervention period), during which time participants recruited to the pilot were able to access community and medical supports as usual at their own initiation. Participants in the wait-list control condition were invited to participate in the SOLAR program, which commenced at the end of the control period.
Control group
Active

Outcomes
Primary outcome [1] 319523 0
Distress (depression and anxiety) symptoms as measured by the Hopkins Symptom Checklist (HSCL-25; Mollica, McDonald, Massagli & Silove, 2004) (adapted for Tuvalu, Gibson, 2019).
Timepoint [1] 319523 0
Post-intervention (within 1 week of completing intervention)
Six-months post-intervention
Secondary outcome [1] 368574 0
Posttraumatic stress symptoms as measured by the The PTSD Checklist for DSM-5 (PCL-5; Weathers et al, 2013)
Timepoint [1] 368574 0
Post-intervention (within 1 week of completing intervention)
Six-months post-intervention
Secondary outcome [2] 368575 0
Distress-induced impairment as measured by the Tuvalu Impairment Checklist (Gibson, 2019)
Timepoint [2] 368575 0
Post-intervention (within 1 week of completing intervention)
Six-months post-intervention
Secondary outcome [3] 368576 0
Participant-identified problems, associated difficulties in functioning, and sense of wellbeing, as measured by the The Psychological Outcome Profiles instrument (PSYCHLOPS; Ashworth, 2004)
Timepoint [3] 368576 0
Post-intervention (within 1 week of completing intervention)
Six-months post-intervention
Secondary outcome [4] 369292 0
Coaches’ levels of knowledge, as measured by a study-specific 15 item multiple choice questionnaire.
Timepoint [4] 369292 0
Day 6 (last day) of Coach training program
Secondary outcome [5] 369293 0
Coaches’ confidence in delivering the SOLAR intervention, as measured by a study-specific questionnaire comprising 5, Likert-scale items.
Timepoint [5] 369293 0
Day 6 (last day) of Coach training program
Secondary outcome [6] 369294 0
Coaches’ clinical decision making (in response to provided clinical vignettes)
Timepoint [6] 369294 0
Day 6 (last day) of Coach training program

Eligibility
Key inclusion criteria
Age of 18 or older

At least mild anxiety / depression symptoms: HSCL-25 > 1.25 and/or posttraumatic stress disorder symptoms: PCL-5 >15.

Self-report functional impairment in at least one out of five areas of daily life as a result of the distress symptoms: Tuvalu Functional Impairment Scale > 1 (total average score of five items ranging from 1 = no impairment to 4 = extreme impairment).

Are able to commit to attending the five sessions included in the SOLAR program as well as pre- and post-intervention assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
At imminent risk of self-harm or suicide according to structured clinical interview.

Severe mental disorder or cognitive impairment (e.g., severe intellectual disability, dementia, psychosis, intoxication) assessed by self-report or observation by interviewer

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
Parallel
Other design features
Non-randomised, delayed treatment control group design.
Group 1 exposed to control condition followed by intervention condition.
Group 2 exposed to intervention condition only, while Group 1 was exposed to control condition.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All outcomes measures will be treated as summed scale scores. Outcomes will be captured at two time points: pre-intervention and post-intervention (as well as pre- and postcontrol in the Funafuti group only). Given the preliminary nature of the study and primary focus on establishing the feasibility and safety of the intervention, there will be a small sample size selected. Recognising the concomitant low levels of statistical power for the study, we will produce effect size estimates for repeated measures (standardised by the variability in change scores), with 95% Confidence Intervals (95% CIs), to quantify the magnitude of within-group change in each outcome from pre-intervention to post-intervention. Paired samples t-test will also be reported (although we do not expect that effect will be statistically significant given the low levels of power), while individual trajectories will be displayed graphically in order to explore variability in individual scores over time.

Further analyses will be conducted to examine comparisons involving pre-intervention to post-intervention scores for participants who received the intervention (Nui group only), versus pre-control to post-control scores for participants who received usual care (i.e., involving informal community, familial and church-based support; access to traditional healers; and access to medical care from non-mental health specialists). These will
comprise a series of regression models (for example, linear or count regression depending on the distribution of the outcome variables), which will specify the post-intervention scores as endogenous variables, and a binary indicator of group status as an explanatory variable. Given the quasi-experimental nature of the study (and thus lack of randomised equivalence of groups), these regression models will also include controls for baseline scores and major confounding variables including age, gender, exposure to cyclone impacts, and poverty indicators.

Data file preparation and preliminary analyses will be conducted in SPSS version 24, while subsequent analyses will be conducted in Program R. Paired sample t-tests will be used to examine change in coaches’ levels of knowledge, confidence in delivering the intervention, and clinical decision making (in response to provided clinical vignettes) pre and post-training. All quantitative analyses will be completed using SPSS.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
13/10/2018
Date of last participant enrolment
Anticipated
Actual
26/10/2018
Date of last data collection
Anticipated
22/05/2019
Actual
Sample size
Target
60
Accrual to date
Final
79
Recruitment outside Australia
Country [1] 21362 0
Tuvalu
State/province [1] 21362 0
Funafuti, Nui

Funding & Sponsors
Funding source category [1] 301978 0
Government body
Name [1] 301978 0
Australian Department of Foreign Affairs and Trade
Country [1] 301978 0
Australia
Primary sponsor type
Other
Name
Phoenix Australia - Centre for Posttraumatic Mental Health
Address
Level 3, 161 Barry Street
Carlton, VIC 3053, Australia
Country
Australia
Secondary sponsor category [1] 301752 0
Charities/Societies/Foundations
Name [1] 301752 0
Australian Red Cross
Address [1] 301752 0
National Office
23/47 Villiers St,
North Melbourne VIC 305
Country [1] 301752 0
Australia
Other collaborator category [1] 280617 0
Other
Name [1] 280617 0
The Congregational Christian Church of Tuvalu (the EKT)
Address [1] 280617 0
PO Box 2,
Valuku, Funafuti
Tuvalu
Country [1] 280617 0
Tuvalu
Other collaborator category [2] 280618 0
Charities/Societies/Foundations
Name [2] 280618 0
Tuvalu Association of Non-Governmental Organisations (TANGO)
Address [2] 280618 0
P O Box 136,
Funafuti,
Tuvalu
Country [2] 280618 0
Tuvalu

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302657 0
University of Melbourne Human Ethics Sub-Committee (HESC)
Ethics committee address [1] 302657 0
Ethics committee country [1] 302657 0
Australia
Date submitted for ethics approval [1] 302657 0
02/07/2018
Approval date [1] 302657 0
24/08/2018
Ethics approval number [1] 302657 0
1852041

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

Contacts
Principal investigator
Name 90958 0
Prof Meaghan O'Donnell
Address 90958 0
Phoenix Australia | Centre for Posttraumatic Mental Health
Department of Psychiatry | The University of Melbourne
Level 3, 161 Barry Street
Carlton, VIC 3053, Australia
Country 90958 0
Australia
Phone 90958 0
+61 3 9035 5599
Fax 90958 0
+61 3 9035 5455
Email 90958 0
[email protected]
Contact person for public queries
Name 90959 0
Meaghan O'Donnell
Address 90959 0
Phoenix Australia | Centre for Posttraumatic Mental Health
Department of Psychiatry | The University of Melbourne
Level 3, 161 Barry Street
Carlton, VIC 3053, Australia
Country 90959 0
Australia
Phone 90959 0
+61 3 9035 5599
Fax 90959 0
+61 3 9035 5455
Email 90959 0
[email protected]
Contact person for scientific queries
Name 90960 0
Meaghan O'Donnell
Address 90960 0
Phoenix Australia | Centre for Posttraumatic Mental Health
Department of Psychiatry | The University of Melbourne
Level 3, 161 Barry Street
Carlton, VIC 3053, Australia
Country 90960 0
Australia
Phone 90960 0
+61 3 9035 5599
Fax 90960 0
+61 3 9035 5455
Email 90960 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
Participants were not asked to provide consent for public data access.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 376975-(Uploaded-27-09-2021-11-23-28)-Basic results summary.docx
Plain language summaryNo Evidence-based interventions are needed to support... [More Details]

Documents added automatically
No additional documents have been identified.