Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000352707
Ethics application status
Approved
Date submitted
18/02/2022
Date registered
25/02/2022
Date last updated
20/02/2023
Date data sharing statement initially provided
25/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Resilience training in the early parenting workforce & harnessing expertise for intervention redesign
Scientific title
The effect of training in adaptive self-reflection on perceived resilience and mood symptoms in client-facing professionals who work with distressed parents, and testing novel moderators and mediators
Secondary ID [1] 306474 0
Nil known
Universal Trial Number (UTN)
U1111-1274-6386
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 325333 0
Anxiety 325334 0
Burnout 325336 0
Condition category
Condition code
Mental Health 322718 322718 0 0
Depression
Mental Health 322719 322719 0 0
Anxiety
Mental Health 322720 322720 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Self-Reflection Resilience Training

Materials: Briefing slides; participant workbook; telephone coaching protocol; debriefing slides

Procedures:
i. 40-minute introduction and training session (group training face-to-face or online, or individual online)
ii. Five 15-minute guided self-reflection writing tasks, once per week for five weeks
iii. Two 20-minute coaching calls during this 5-week period
iv. 30-minute group debrief (face-to-face or online)

Content:
i. Introduction and training. This session covers: the concept of resilience and how it can develop over time in response to stressors; types of stressors; 3 key resilient skills (resilient beliefs, good coping strategies, and available resources); identifying core values; a process of self-reflection to understand stress responses, strengths and areas for development; and an overview of the forthcoming writing tasks and coaching calls.
ii. Self-reflection writing tasks. The first four tasks guide participants through a process of self-reflection on a stressor event from the past week, including examining their reactions, identifying and evaluating the coping strategies they employed, and thinking about future options. The fifth task encourages participants to reflect across the previous four weeks, reviewing their workbook entries to identify emerging patterns in their stressors, responses and strategies. The participant workbook is designed especially for this study, based on prior work by A/Prof. Crane's team.
iii. Telephone coaching sessions. Following a standardised script, coaches confirm consent for the call, monitor participant wellbeing, check in re. completion of self-reflection activities, and encourage participants to discuss their self-reflection responses in more detail.
iv. Debrief. In this group session, the trainer invites participants to share personal insights from the final self-reflection writing task, and encourages participants to continue reflecting on stressor events in the future, using the questions and techniques covered in this program.

Who: The intervention will be delivered by a postdoctoral researcher (PhD in Psychology) and an Organisational Psychology Masters student (provisionally registered psychologist).

Mode of delivery:
i. Introduction and training. Flexible, including group training face-to-face or online (trainer PowerPoint presentation, in person or in Zoom meeting) or individual online (prerecorded trainer PowerPoint presentation, accessed at participant convenience). The mode of delivery will be determined by several factors, including organisational capacity (time for group training, availability of training room), geographical spread of participants, and participant availability, preference, and access to technology.
ii. Self-reflection writing tasks: Individual self-paced in workbooks
iii. Telephone coaching sessions: Individual by phone
iv. Debrief: Group face-to-face or online (trainer PowerPoint presentation, in person or in Zoom meeting, with discussion). The mode of delivery will be determined by factors including organisational capacity (time for group training, availability of training room), geographical spread of participants, and participant availability, preference, and access to technology.

Location: Flexible, including workplace (Tresillian Family Care Centres for all face-to-face and some online and self-reflection task components) and participants' own homes (for some online and self-reflection task components).

Adherence: Intervention adherence will be monitored via attendance records (training and debrief sessions), degree of participation in coaching calls (as assessed by coach), self-reported completion of writing tasks (discussed in coaching calls), verbal confirmation during debrief sessions, and relevant questions from the training engagement measure at Time 3.

The intervention will be adapted for the Tresillian workforce and context during an initial staff consultation period. Five to ten staff volunteers, including managers and representatives of the target workforce, will participate in a 30-minute interview or 60-minute focus group (according to participant availability) conducted via phone or Zoom by members of the research team. These will be audio recorded. Questions will explore: the nature of challenges experienced in the workplace; perceived effects of these challenges (especially, the nature – e.g., stress, depression, anxiety, burnout – and extent of distress experienced); any prior workplace training in resilience/coping; what strategies participants have tried to manage challenges; what strategies participants perceive to have been successful; possible modalities for the current training; opportunities for managers to help support training engagement.
Intervention code [1] 322900 0
Prevention
Intervention code [2] 322901 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330520 0
Mean depression score on the Patient Health Questionnaire (PHQ-9)
Timepoint [1] 330520 0
Baseline, immediately post-intervention and 3 months post-intervention (primary timepoint)
Primary outcome [2] 330521 0
Mean anxiety score on the Generalized Anxiety Disorder Assessment (GAD-7)
Timepoint [2] 330521 0
Baseline, immediately post-intervention and 3 months post-intervention (primary timepoint)
Primary outcome [3] 330522 0
Mean perceived resilience score on the Brief Resilience Scale (BRS)
Timepoint [3] 330522 0
Baseline, immediately post-intervention and 3 months post-intervention (primary timepoint)
Secondary outcome [1] 406518 0
Mean stress score on the Stress sub-scale of the Depression Anxiety Stress Scales (DASS-21)
Timepoint [1] 406518 0
Baseline, immediately post-intervention and 3 months post-intervention
Secondary outcome [2] 406519 0
Mean burnout score on the Oldenburg Burnout Inventory
Timepoint [2] 406519 0
Baseline, immediately post-intervention and 3 months post-intervention
Secondary outcome [3] 406520 0
Mean positive and negative affect scores on the Positive and Negative Affect Scale (PANAS)
Timepoint [3] 406520 0
Baseline, immediately post-intervention and 3 months post-intervention
Secondary outcome [4] 406676 0
Mean score on the Self-Reflection Scale (created for this study)
Timepoint [4] 406676 0
Baseline, immediately post-intervention and 3 months post-intervention
Secondary outcome [5] 406677 0
Mean score on the Coping Insight Scale (created for this study)
Timepoint [5] 406677 0
Baseline, immediately post-intervention and 3 months post-intervention
Secondary outcome [6] 406678 0
Mean score on the Coping Self-Efficacy Scale
Timepoint [6] 406678 0
Baseline, immediately post-intervention and 3 months post-intervention
Secondary outcome [7] 406680 0
Mean score on the Stressor Benefit Scale
Timepoint [7] 406680 0
Baseline, immediately post-intervention and 3 months post-intervention
Secondary outcome [8] 406681 0
Mean score on the Stress Mindset Measure - General
Timepoint [8] 406681 0
Baseline, immediately post-intervention and 3 months post-intervention
Secondary outcome [9] 406682 0
Mean score on the Training Engagement Scale
Timepoint [9] 406682 0
Baseline, immediately post-intervention and 3 months post-intervention

Eligibility
Key inclusion criteria
All client-facing employees of Tresillian Family Care Centres aged 18 years or over who are willing to participate are eligible to be included
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Insufficient English proficiency to participate in training and complete study measures

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
The sample size was primarily determined by the time-frame of the study (dictated by funding conditions) and organisational capacity as determined by Tresillian management.

We will employ multilevel modelling to understand interactions among variables over time. We will undertake thematic analysis on free text, interview, and focus group data, to identify adaptations to SRT that are recommended to make it suitable for new parents.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2022
Actual
27/06/2022
Date of last participant enrolment
Anticipated
29/04/2022
Actual
20/07/2022
Date of last data collection
Anticipated
9/09/2022
Actual
29/11/2022
Sample size
Target
50
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21783 0
Tresillian Family Care Centre - Belmore - Belmore
Recruitment hospital [2] 21809 0
Tresillian Nepean Family Care Centre - Kingswood
Recruitment hospital [3] 21810 0
Tresillian Willoughby Family Care Centre - Willoughby
Recruitment hospital [4] 21811 0
Tresillian Wollstonecraft Family Care Centre - Wollstonecraft
Recruitment hospital [5] 21813 0
Tresillian Lismore - Lismore
Recruitment hospital [6] 21814 0
Tresillian in Murrumbidgee - Wagga Wagga - Wagga Wagga
Recruitment hospital [7] 21815 0
Tresillian Coffs Harbour - Coffs Harbour
Recruitment hospital [8] 21816 0
Tresillian In Southern - Queanbeyan - Karabar
Recruitment hospital [9] 21817 0
Tresillian in Western - Dubbo - Dubbo
Recruitment hospital [10] 21819 0
Tresillian in Far West - Broken Hill - Broken Hill
Recruitment hospital [11] 21820 0
Tresillian In Manning - Taree - Taree
Recruitment hospital [12] 21821 0
Tresillian Macksville - Macksville
Recruitment postcode(s) [1] 36839 0
2192 - Belmore
Recruitment postcode(s) [2] 36867 0
2747 - Kingswood
Recruitment postcode(s) [3] 36868 0
2068 - Willoughby
Recruitment postcode(s) [4] 36869 0
2065 - Wollstonecraft
Recruitment postcode(s) [5] 36871 0
2480 - Lismore
Recruitment postcode(s) [6] 36872 0
2650 - Wagga Wagga
Recruitment postcode(s) [7] 36873 0
2450 - Coffs Harbour
Recruitment postcode(s) [8] 36874 0
2620 - Karabar
Recruitment postcode(s) [9] 36875 0
2830 - Dubbo
Recruitment postcode(s) [10] 36877 0
2880 - Broken Hill
Recruitment postcode(s) [11] 36878 0
2430 - Taree
Recruitment postcode(s) [12] 36879 0
2447 - Macksville

Funding & Sponsors
Funding source category [1] 310821 0
University
Name [1] 310821 0
Macquarie University
Country [1] 310821 0
Australia
Primary sponsor type
Individual
Name
Dr Anne-Marie Maxwell
Address
School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 312067 0
Individual
Name [1] 312067 0
Associate Professor Monique Crane
Address [1] 312067 0
School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
Country [1] 312067 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310387 0
Macquarie University Human Research Ethics Committee (Medical Sciences)
Ethics committee address [1] 310387 0
Ethics committee country [1] 310387 0
Australia
Date submitted for ethics approval [1] 310387 0
16/02/2022
Approval date [1] 310387 0
Ethics approval number [1] 310387 0
Ethics committee name [2] 312470 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 312470 0
Ethics committee country [2] 312470 0
Australia
Date submitted for ethics approval [2] 312470 0
04/04/2022
Approval date [2] 312470 0
10/06/2022
Ethics approval number [2] 312470 0
X22-0096 & 2022/ETH00618

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

Contacts
Principal investigator
Name 117478 0
Dr Anne-Marie Maxwell
Address 117478 0
School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
Country 117478 0
Australia
Phone 117478 0
+61 437 500 514
Fax 117478 0
Email 117478 0
anne-marie.maxwell@mq.edu.au
Contact person for public queries
Name 117479 0
Anne-Marie Maxwell
Address 117479 0
School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
Country 117479 0
Australia
Phone 117479 0
+61437500514
Fax 117479 0
Email 117479 0
anne-marie.maxwell@mq.edu.au
Contact person for scientific queries
Name 117480 0
Anne-Marie Maxwell
Address 117480 0
School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
Country 117480 0
Australia
Phone 117480 0
+61437500514
Fax 117480 0
Email 117480 0
anne-marie.maxwell@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified raw data on all variables collected
When will data be available (start and end dates)?
Data will be available immediately following publication of results, with no end date determined.
Available to whom?
Data will be made available to researchers who are interested in similar research questions and who provide a methodologically sound proposal to the Principal Investigator.
Available for what types of analyses?
IPD will be made available for IPD meta-analyses. Other uses will be considered on a case-by-case basis.
How or where can data be obtained?
Access to data is subject to approvals by Principal Investigator. Interested parties should contact the PI on anne-marie.maxwell@mq.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15158Study protocol  anne-marie.maxwell@mq.edu.au To be uploaded once ethical approval has been rece... [More Details]
15159Informed consent form  anne-marie.maxwell@mq.edu.au To be uploaded once ethical approval has been rece... [More Details]
15160Ethical approval    To be uploaded once ethical approval has been rece... [More Details]



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.