Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001530314
Ethics application status
Approved
Date submitted
19/10/2017
Date registered
3/11/2017
Date last updated
19/03/2021
Date data sharing statement initially provided
19/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Pursuit of Wellbeing: Staff and Parent Wellbeing in Disability Services
Scientific title
Trialling an intervention to support the wellbeing of parents of children with a disability and staff wellbeing: The Pursuit of Wellbeing Study
Secondary ID [1] 293182 0
None
Universal Trial Number (UTN)
U1111-1194-3587
Trial acronym
PoW Study (The Pursuit of Wellbeing: Staff and Parent Wellbeing in Disability Services)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 302524 0
Parental mental health 302525 0
Job-related wellbeing 305156 0
Condition category
Condition code
Public Health 302067 302067 0 0
Health service research
Public Health 302068 302068 0 0
Health promotion/education
Mental Health 302069 302069 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Yooralla will be implementing the program (intervention) across the service's six sites (using a staged process - stepped wedge study design) and all Key Workers and Managers will receive the program as part of their systems change directed by the Executive Management.
The training component of the intervention will be delivered to the first 2 sites in September 2017 with 2 additional sites crossing over to receive the intervention 3 months later in December 2017 and the final group of 2 sites crossing over to receive the intervention in March 2018. Implementation of the program is ongoing once the group of hubs have been exposed to the intervention.

The program will include:
1) Key worker and Manager training to support parental wellbeing, including information around supporting parental wellbeing, particularly to identify red flags and be able to refer onto appropriate supports; as well as supporting staff job-related wellbeing.
Delivery
Key workers will receive 1 x day of training at their place of employment which will be delivered as two modules 1) strengthening capacity to support parental wellbeing and 2) staff wellbeing and role boundaries. Managers will receive an additional 2 hours of training which will focus on strategies to strengthen support for their staff around staff self-care for their wellbeing and promoting debriefing and counselling options if experiencing heightened stress or distress. The training will be delivered by a professional organisational psychologist, and designed to include educational modules, role-play activities and discussion.
Modules
a) Strengthening capacity to support parental wellbeing
• How to identify issues with a parent’s wellbeing; identifying mental health ‘red flags’; how to support the wellbeing of parents and carers of children with a disability; dealing with complex families; addressing parental and family wellbeing through routine care and referral to appropriate services
• Role play activities about: how to manage difficult conversations with parents

b) Staff wellbeing and role boundaries
• How to identify and manage stress in the workplace; self-care strategies; clearer outline of key worker roles, responsibilities and boundaries. Team support strategies.
• Role play activities: how to debrief with another staff member and your manager
• Utilising the referral pathways document

c) Manager Training
• How to identify and manage stress in the workplace for yourself and your staff; promotion of key worker role boundaries. Team support strategies.
• Role play activities: how to debrief with your staff member
• Providing expertise in parental wellbeing and assuming the “Champion” role for your team.

2) Access to someone with expertise in parental wellbeing (to be known as the “Champion”). Managers will receive extra training (as described above) to support them in their conversations with Key Workers on supporting parents’ wellbeing and to act as a 'champion' for the team. This aims to build the capacity of managers to assist key workers with potentially difficult work events. This will be provided as necessary to staff, time dependent on staff needs and will involve debriefing and problem solving between managers and staff . This is tailored specifically for staff.

3) Provision of a referral pathways document (mental health supports, peer supports and other relevant local services) – this document will be developed for each Hub and provided to all Key Workers and Managers. The referral pathway document will be introduced during the training and will be an ongoing resource for the organisation. This resource will be updated as necessary by the Director of Allied Services and Wellbeing.

4) Formalised debriefing process for staff – ensuring staff are aware of the options for de-briefing and counselling. Access to debriefing process for staff will be introduced during the manager training and will be an ongoing process for the organisation. Managers will share this information with their staff at team meetings and promote the use of regular debriefing or as necessary. Staff will be familiar with debriefing and counselling options within the organisation , such as during fortnightly supervision meetings or confidential access to the Employee Assistance Program (EAP).
Intervention code [1] 297528 0
Behaviour
Intervention code [2] 297529 0
Prevention
Intervention code [3] 299419 0
Lifestyle
Comparator / control treatment
Using a stepped wedge cluster control design allows each hub or cluster to act as its own “pre versus post” control and, in the first two periods, there are at least two hubs acting as controls and at least two hubs receiving the program.
Control group
Active

Outcomes
Primary outcome [1] 301496 0
Key Workers and Managers self-efficacy (confidence) in supporting the wellbeing of parents.
Instrument: Developed items based on Bandura's recommendation that self-efficacy questionnaire's are task-specific
Timepoint [1] 301496 0
Baseline, every 3 months after randomisation for 9 months.
Secondary outcome [1] 332849 0
Key Workers and Managers perceptions of supervisory support
Instrument: Perceived Supervisor Support scale
Timepoint [1] 332849 0
Baseline, every 3 months after randomisation for 9 months.
Secondary outcome [2] 332850 0
Staff job-related mental wellbeing
Instrument: Warr's Job related wellbeing measure; Mental wellbeing will be measured also using the Shortened Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [2] 332850 0
Baseline, every 3 months after randomisation for 9 months
Secondary outcome [3] 332851 0
Parent satisfaction with Key Workers
Instrument: New items have been developed to assess mothers’ perception of support from their key worker. This scale has been designed specifically for this study.
Timepoint [3] 332851 0
Baseline, every 3 months after randomisation for 9 months
Secondary outcome [4] 332852 0
Parent wellbeing
Instrument: Mental wellbeing will be measured also using the Shortened Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [4] 332852 0
Baseline, every 3 months after randomisation for 9 months
Secondary outcome [5] 332853 0
Cost consequence analysis: Is the program good value for money and affordable
Instrument: Short version of WHO Health and Performance Questionnaire (HPQ)
Timepoint [5] 332853 0
Baseline, every 3 months after randomisation for 9 months

Eligibility
Key inclusion criteria
Staff: Currently employed staff working within the service (Yooralla's Children's Services Early Childhood Intervention Service) receiving the intervention.
Parents: Parents who access the Early Childhood Intervention Service receiving the intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria.

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)
Partly randomized design. Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For managerial reasons, the first two hubs will not be randomly selected. Two hubs will be selected based on readiness to undergo the trial and will receive the program immediately after baseline is established, with the remaining four hubs randomised, two at a time, every 3 months thereafter. In this way, hubs that were previously acting as control hubs, will progressively receive the program.
Simple randomisation using a randomisation table of random digits will be used to randomise the remaining 4 hubs. Cochran, WG (1977) Sampling techniques. 3rd Edition, John Wiley & Sons. Page 19, Table 2.1, entered at row 09 and column 22.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study uses a stepped wedge cluster non-randomized controlled trial design. The stepped wedge design is suitable for a phased evaluation approach, such as this, in which there is an imperative to allow all participants to have access to the new program. The design also allows each hub or cluster to act as its own “pre versus post” control and, in the first two periods, there are at least two hubs acting as controls and at least two hubs receiving the program. We seek to minimize potential bias by not revealing to the Key Workers when the new program is scheduled to be allocated to their hub.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The repeated measurements (four in total) on individuals in the 6 hubs over the three 3-month periods will be analysed using linear mixed models. For measurement scales that are not too coarse (e.g. > 7 distinct values) the statistical analyses will make use of the REML algorithm to fit the mixed model. This algorithm will take account of missing (at random) assessments and also allows the exploration of various autocorrelation models for the repeated measurements. Comparison of the “control” and “new program” means (adjusted for period effects) will be assessed with an F-test. If required, after inspection of diagnostic plots of residuals and fitted values, an empirical logit transformation will be used to re-analyse any item-scales that are bounded and coarse. Generalized linear mixed model techniques will be used to analyse binomial or other categorical data. Cumulative effects of exposure to the new program on key outcome variables will also be explored using the same methods. The final analysis will be conducted after all participants have had adequate opportunity to be assessed at the end of the third period (i.e. at 9 months) and the database has been locked.
The focus groups and interviews will be recorded and transcribed verbatim. Qualitative data will be analysed and coded for emergent themes using a grounded theory approach.
The sample size (6 hubs) is essentially pragmatically determined and limited by the number of hubs in Victoria and the roll-out period for the intervention. We expect approximately 8 out of 10 Key Workers located at each hub to consent to be repeatedly assessed (at 0, 3, 6 and 9 months) following the start of the study and approximately 3 out of the 10 families that they each support to consent to be surveyed during the study. The implications of this pragmatic choice, for the investigation of the outcome variables, can be explored by considering one of the key outcome measures, namely the mental well-being of Key Workers as assessed by the short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS). Accordingly we expect to have 192 observations of the SWEMWBS (6 hubs x 8 Key Workers x 4 measurement occasions). Based on 1000 simulations of this BDOS (viz SWEMWBS) for each conjectured scenario we find the study has 80% power to detect an increase, due to the intervention, in the mean well-being of 2.6 units (i.e. an effect size of 0.61) when the ICC is 0.25 and there is allowance for a mild “global” increasing, and confounding, trend of up to 2 units across the 9 months of the study. Moreover, when, optimistically, ICC=0.5, the power, ceteris paribus, increases to 93% and a smaller effect difference of 2.08, i.e. an effect size of 0.49, can be detected with 80% power. Accordingly, we conclude that this study has moderate to high power to detect small to moderate effect sizes for outcome variables that are measured repeatedly on Key Workers.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
30/11/2017
Actual
11/05/2018
Date of last data collection
Anticipated
31/12/2018
Actual
28/02/2020
Sample size
Target
220
Accrual to date
Final
101
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295938 0
Government body
Name [1] 295938 0
National Health and Medical Research Council
Country [1] 295938 0
Australia
Funding source category [2] 297800 0
Other Collaborative groups
Name [2] 297800 0
Yooralla
Country [2] 297800 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Level 5, 207 Bouverie St, Carlton, VIC 3053
Country
Australia
Secondary sponsor category [1] 294831 0
University
Name [1] 294831 0
Deakin University Health Economics
Address [1] 294831 0
Deakin University, Burwood Hwy, Burwood, VIC, 3125
Country [1] 294831 0
Australia
Secondary sponsor category [2] 296839 0
University
Name [2] 296839 0
The Royal Children's Hospital
Address [2] 296839 0
50 Flemington Rd, Parkville, VIC, 3052
Country [2] 296839 0
Australia
Other collaborator category [1] 279774 0
University
Name [1] 279774 0
Monash University
Address [1] 279774 0
The Alfred Centre, 99 Commercial Rd, Melbourne, Vic, 3004
Country [1] 279774 0
Australia
Other collaborator category [2] 279775 0
Other Collaborative groups
Name [2] 279775 0
Centre for Developmental Disablity Health Victoria - Monash Health
Address [2] 279775 0
122 Thomas Street, Dandenong, VIC, 3175
Country [2] 279775 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297220 0
The University of Melbourne Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 297220 0
Ethics committee country [1] 297220 0
Australia
Date submitted for ethics approval [1] 297220 0
03/03/2017
Approval date [1] 297220 0
05/05/2017
Ethics approval number [1] 297220 0
1648536

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2126 2126 0 0
/AnzctrAttachments/372578-Signed approval Letter from HESC.pdf

Contacts
Principal investigator
Name 73370 0
A/Prof Lisa Gibbs
Address 73370 0
Child and Community Wellbeing Unit The Centre for Health Equity, Melbourne School of Population and Global Health, The University of Melbourne, Level 5, 207 Bouverie St, Carlton, Vic, 3053
Country 73370 0
Australia
Phone 73370 0
+61 3 8344 0920
Fax 73370 0
Email 73370 0
[email protected]
Contact person for public queries
Name 73371 0
Dana Young
Address 73371 0
Child and Community Wellbeing Unit The Centre for Health Equity, Melbourne School of Population and Global Health, The University of Melbourne, Level 5, 207 Bouverie St, Carlton, Vic, 3053
Country 73371 0
Australia
Phone 73371 0
+61 3 90359870
Fax 73371 0
Email 73371 0
[email protected]
Contact person for scientific queries
Name 73372 0
Dana Young
Address 73372 0
Child and Community Wellbeing Unit The Centre for Health Equity, Melbourne School of Population and Global Health, The University of Melbourne, Level 5, 207 Bouverie St, Carlton, Vic, 3053
Country 73372 0
Australia
Phone 73372 0
+61 3 90359870
Fax 73372 0
Email 73372 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
Consent was not obtained to share this data wider than the research group


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11090Study protocol• Davis E, Young D, Gilson KM, Reynolds J, Carter R, Tonmukayakul U, Williams K, Gibbs L, McDonald R, Reddihough D, Tracy J, Morgan J, Ireland P, Kenyon C, Carracher R. A capacity building program to improve the self-efficacy of key workers to support the wellbeing of parents of a child with a disability accessing an Early Childhood Intervention Service: protocol for a stepped-wedge design trial. JMIR Res Protoc (8:4 (e12531)   372578-(Uploaded-25-09-2020-17-32-30)-Study-related document.pdf
11091Ethical approval    372578-(Uploaded-25-09-2020-17-33-38)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA Capacity Building Program to Improve the Self-Efficacy of Key Workers to Support the Well-Being of Parents of a Child With a Disability Accessing an Early Childhood Intervention Service: Protocol for a Stepped-Wedge Design Trial2019https://doi.org/10.2196/12531
N.B. These documents automatically identified may not have been verified by the study sponsor.