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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
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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
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Secondary ID [1]
306474
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Nil known
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Universal Trial Number (UTN)
U1111-1274-6386
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
325333
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Anxiety
325334
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Burnout
325336
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Condition category
Condition code
Mental Health
322718
322718
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0
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Depression
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Mental Health
322719
322719
0
0
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Anxiety
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Mental Health
322720
322720
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
322900
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Prevention
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Intervention code [2]
322901
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Behaviour
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Mean depression score on the Patient Health Questionnaire (PHQ-9)
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Assessment method [1]
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Timepoint [1]
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Baseline, immediately post-intervention and 3 months post-intervention (primary timepoint)
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Primary outcome [2]
330521
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Mean anxiety score on the Generalized Anxiety Disorder Assessment (GAD-7)
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Assessment method [2]
330521
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Timepoint [2]
330521
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Baseline, immediately post-intervention and 3 months post-intervention (primary timepoint)
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Primary outcome [3]
330522
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Mean perceived resilience score on the Brief Resilience Scale (BRS)
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Assessment method [3]
330522
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Timepoint [3]
330522
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Baseline, immediately post-intervention and 3 months post-intervention (primary timepoint)
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Secondary outcome [1]
406518
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Mean stress score on the Stress sub-scale of the Depression Anxiety Stress Scales (DASS-21)
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Assessment method [1]
406518
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Timepoint [1]
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Baseline, immediately post-intervention and 3 months post-intervention
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Secondary outcome [2]
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Mean burnout score on the Oldenburg Burnout Inventory
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Assessment method [2]
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Timepoint [2]
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Baseline, immediately post-intervention and 3 months post-intervention
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Secondary outcome [3]
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Mean positive and negative affect scores on the Positive and Negative Affect Scale (PANAS)
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Assessment method [3]
406520
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Timepoint [3]
406520
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Baseline, immediately post-intervention and 3 months post-intervention
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Secondary outcome [4]
406676
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Mean score on the Self-Reflection Scale (created for this study)
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Assessment method [4]
406676
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Timepoint [4]
406676
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Baseline, immediately post-intervention and 3 months post-intervention
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Secondary outcome [5]
406677
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Mean score on the Coping Insight Scale (created for this study)
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Assessment method [5]
406677
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Timepoint [5]
406677
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Baseline, immediately post-intervention and 3 months post-intervention
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Secondary outcome [6]
406678
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Mean score on the Coping Self-Efficacy Scale
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Assessment method [6]
406678
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Timepoint [6]
406678
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Baseline, immediately post-intervention and 3 months post-intervention
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Secondary outcome [7]
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Mean score on the Stressor Benefit Scale
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Assessment method [7]
406680
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Timepoint [7]
406680
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Baseline, immediately post-intervention and 3 months post-intervention
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Secondary outcome [8]
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Mean score on the Stress Mindset Measure - General
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Assessment method [8]
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Timepoint [8]
406681
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Baseline, immediately post-intervention and 3 months post-intervention
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Secondary outcome [9]
406682
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Mean score on the Training Engagement Scale
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Assessment method [9]
406682
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Timepoint [9]
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Baseline, immediately post-intervention and 3 months post-intervention
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Insufficient English proficiency to participate in training and complete study measures
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/04/2022
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Actual
27/06/2022
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Date of last participant enrolment
Anticipated
29/04/2022
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Actual
20/07/2022
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Date of last data collection
Anticipated
9/09/2022
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Actual
29/11/2022
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Sample size
Target
50
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Accrual to date
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Final
43
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
21783
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Tresillian Family Care Centre - Belmore - Belmore
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Recruitment hospital [2]
21809
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Tresillian Nepean Family Care Centre - Kingswood
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Recruitment hospital [3]
21810
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Tresillian Willoughby Family Care Centre - Willoughby
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Recruitment hospital [4]
21811
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Tresillian Wollstonecraft Family Care Centre - Wollstonecraft
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Recruitment hospital [5]
21813
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Tresillian Lismore - Lismore
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Recruitment hospital [6]
21814
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Tresillian in Murrumbidgee - Wagga Wagga - Wagga Wagga
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Recruitment hospital [7]
21815
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Tresillian Coffs Harbour - Coffs Harbour
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Recruitment hospital [8]
21816
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Tresillian In Southern - Queanbeyan - Karabar
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Recruitment hospital [9]
21817
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Tresillian in Western - Dubbo - Dubbo
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Recruitment hospital [10]
21819
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Tresillian in Far West - Broken Hill - Broken Hill
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Recruitment hospital [11]
21820
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Tresillian In Manning - Taree - Taree
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Recruitment hospital [12]
21821
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Tresillian Macksville - Macksville
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Recruitment postcode(s) [1]
36839
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2192 - Belmore
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Recruitment postcode(s) [2]
36867
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2747 - Kingswood
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Recruitment postcode(s) [3]
36868
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2068 - Willoughby
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Recruitment postcode(s) [4]
36869
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2065 - Wollstonecraft
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Recruitment postcode(s) [5]
36871
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2480 - Lismore
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Recruitment postcode(s) [6]
36872
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2650 - Wagga Wagga
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Recruitment postcode(s) [7]
36873
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2450 - Coffs Harbour
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Recruitment postcode(s) [8]
36874
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2620 - Karabar
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Recruitment postcode(s) [9]
36875
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2830 - Dubbo
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Recruitment postcode(s) [10]
36877
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2880 - Broken Hill
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Recruitment postcode(s) [11]
36878
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2430 - Taree
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Recruitment postcode(s) [12]
36879
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2447 - Macksville
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Funding & Sponsors
Funding source category [1]
310821
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University
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Name [1]
310821
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Macquarie University
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Address [1]
310821
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Balaclava Road
North Ryde
NSW 2109
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Country [1]
310821
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Australia
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Primary sponsor type
Individual
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Name
Dr Anne-Marie Maxwell
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Address
School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
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Country
Australia
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Secondary sponsor category [1]
312067
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Individual
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Name [1]
312067
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Associate Professor Monique Crane
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Address [1]
312067
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School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
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Country [1]
312067
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310387
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Macquarie University Human Research Ethics Committee (Medical Sciences)
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Ethics committee address [1]
310387
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Macquarie University Balaclava Road North Ryde NSW 2109
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Ethics committee country [1]
310387
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Australia
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Date submitted for ethics approval [1]
310387
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16/02/2022
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Approval date [1]
310387
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Ethics approval number [1]
310387
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Ethics committee name [2]
312470
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Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [2]
312470
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Research Ethics and Governance Office (REGO) Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
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Ethics committee country [2]
312470
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Australia
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Date submitted for ethics approval [2]
312470
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04/04/2022
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Approval date [2]
312470
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10/06/2022
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Ethics approval number [2]
312470
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X22-0096 & 2022/ETH00618
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Summary
Brief summary
Resilience describes a person’s capacity to “bounce back” from stressful events. Research in some populations indicates that adaptive self-reflection on daily stressors can facilitate the development of resilience. We are exploring whether this might be true for staff who work with stressed parents – and whether training in this method might also be adapted for new parents themselves. This project will apply the Systematic Self-Reflection model of resilience development to: (1) enhance capacities for resilience in staff who work with parents experiencing challenges in the early parenting period, using an existing intervention designed to enhance human resilience - Self-Reflection Resilience Training; and (2) develop professional recommendations for adapting this intervention for use with new parents.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Anne-Marie Maxwell
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Address
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School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
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Country
117478
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Australia
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Phone
117478
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+61 437 500 514
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Fax
117478
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Email
117478
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[email protected]
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Contact person for public queries
Name
117479
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Anne-Marie Maxwell
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Address
117479
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School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
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Country
117479
0
Australia
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Phone
117479
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+61437500514
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Fax
117479
0
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Email
117479
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[email protected]
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Contact person for scientific queries
Name
117480
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Anne-Marie Maxwell
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Address
117480
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School of Psychological Sciences
Level 2
Australian Hearing Hub
16 University Avenue
Macquarie University
NSW 2109
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Country
117480
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Australia
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Phone
117480
0
+61437500514
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Fax
117480
0
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Email
117480
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified raw data on all variables collected
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When will data be available (start and end dates)?
Data will be available immediately following publication of results, with no end date determined.
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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.
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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.
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How or where can data be obtained?
Access to data is subject to approvals by Principal Investigator. Interested parties should contact the PI on
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
15158
Study protocol
[email protected]
To be uploaded once ethical approval has been rece...
[
More Details
]
15159
Informed consent form
[email protected]
To be uploaded once ethical approval has been rece...
[
More Details
]
15160
Ethical approval
To be uploaded once ethical approval has been rece...
[
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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.
Download to PDF