Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001702202
Ethics application status
Approved
Date submitted
3/10/2018
Date registered
16/10/2018
Date last updated
1/12/2020
Date data sharing statement initially provided
1/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Can resilience lessons be usefully integrated into the training of technical skills?
Scientific title
Investigating the application of an integrated approach to resilience training in the Royal Military College.
Secondary ID [1] 296237 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression symptoms 309876 0
Anxiety symptoms 309877 0
Perceived stress 309878 0
Condition category
Condition code
Mental Health 308669 308669 0 0
Anxiety
Mental Health 308670 308670 0 0
Depression
Mental Health 308756 308756 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CADET TRAINING:
Specifically, our approach to resilience training for Cadets is intended to train participants to reflect on adversity as an opportunity for development via coping self-reflection. Five reflective practices are encouraged as part of the training in order to strengthen resilience: (1) awareness of one’s emotional, physical, behavioural and cognitive coping responses to triggering events and the inter-relationships between these responses, (2) awareness of values and value-based goals in relation to the situation, (3) awareness of strategies applied to deal with the situation, (4) evaluation of strategy effectiveness in relation to values and goals and (5) adaptation of strategies to promote improvements in future coping.

CADET INSTRUCTOR TRAINING
In the intervention group, RMC instructors will receive training to integrate the reflective practices during specified exercises by asking questions during after-activity reviews that promote coping and emotion regulatory reflections described above. The training will be delivered by Dr Monique Crane and Ms Madison Kho from Macquarie University. The training will be approximately 2-hours in length and will involve the following face-to-face instruction:
(1) Explaining the utility of self-reflection in developing resilience
(2) Explaining how this could be integrating into the training of technical skills and leadership skills
(3) When it is appropriate to engage Cadet’s in self-reflection
(4) What the self-reflective process is
(5) What questions to ask
(6) Some illustrations and examples
(7) Live practice

During pre-defined field-based exercises, instructors will incorporate certain self-reflective questions that help Cadets to build: (1) self-awareness, (2) self-evaluation skills and (3) self-development.

Such reflective questions include, but are not limited to:
(1) 'How did being given the role of leadership change the way you felt or thought about the situation?',
(2) 'How do you think some of these thoughts or feelings affected your behaviour?',
(3) 'What do you think was the impact of some of these behaviours on the outcomes, your performance or the performance of others in your leadership'?
(4) 'In terms of your goals and leadership values, were you happy with the outcomes of your response to situational demands?'
(5) 'What do you think was a strength in the way you responded to the demands of the situation?'
(6) 'How might you apply such a strength across different situations?',
(7) 'Where do you think you need to develop your skills or knowledge further in relation to how you handled the demands of the situation?',
(8) 'How might you develop that skill or knowledge?

Four trained researchers will observe RMC instructors integrating the reflective questions into their normal instruction. Instructors will be rated on their capacity to integrate the reflective questioning.
Intervention code [1] 312563 0
Prevention
Comparator / control treatment
In the control group, the RMC instructors of these Cadets will not be given the self-reflection training and therefore Cadet instruction will occur as usual. Cadets will not receive instruction that integrates these reflective questions into their typical training instruction. This means that activity de-briefing will only focus on technical skills development (e.g., navigation), rather than addressing the emotional demands of the situation.

As with the experimental condition, four trained researchers will observe RMC instructors during training exercises to ensure that instructors are only training technical skills and not evoking coping and emotion regulatory self-reflection as part of their instruction.
Control group
Active

Outcomes
Primary outcome [1] 307634 0
Anxiety. The Generalized Anxiety Disorder 7-Item (GAD-7) Questionnaire contains 7-items designed to measure symptoms of anxiety and anxiety severity.
Timepoint [1] 307634 0
There are a total of four time points: baseline (T1), at the conclusion of the Cadet's first training exercise (T2), prior to the Cadet's second training exercise (T3), and at the conclusion of the Cadet's second training exercise (T4). The final time point is the primary time point of interest, however we also anticipate differences in change over time and group averages at intermediate (T2/T3) time points.
Primary outcome [2] 307635 0
Depression. The Patient Health Questionnaire – 9 items (PHQ-9) will be used to examine the presence of current depression symptoms and their severity in Cadets at all three time points (Kroenke, et al., 2009 ).
Timepoint [2] 307635 0
There are a total of four time points: baseline (T1), at the conclusion of the Cadet's first training exercise (T2), prior to the Cadet's second training exercise (T3), and at the conclusion of the Cadet's second training exercise (T4). The final time point is the primary time point of interest, however we also anticipate differences in change over time and group averages at intermediate (T2/T3) time points.
Primary outcome [3] 307636 0
Perceived stress. The perceived Stress Scale (PSS: Cohen, Kamarck, & Mermelstein, 1983) is a classic stress assessment instrument.
Timepoint [3] 307636 0
There are a total of four time points: baseline (T1), at the conclusion of the Cadet's first training exercise (T2), prior to the Cadet's second training exercise (T3), and at the conclusion of the Cadet's second training exercise (T4). The final time point is the primary time point of interest, however we also anticipate differences in change over time and group averages at intermediate (T2/T3) time points.
Secondary outcome [1] 352461 0
Perceived frequency of training stressors. This measure is intended to capture the frequency of stressors relevant to the RMC training context.

This list was created in collaboration with an Army psychologist familiar with the training stressors at RMC and an RMC training instructor. There are 23 stressors in this list (e.g., physical demands) and Cadets are asked to indicate how often this stressor occurred in the past week.
Timepoint [1] 352461 0
There are a total of four time points: baseline (T1), at the conclusion of the Cadet's first training exercise (T2), prior to the Cadet's second training exercise (T3), and at the conclusion of the Cadet's second training exercise (T4). The final time point is the primary time point of interest, however we also anticipate differences in change over time and group averages at intermediate (T2/T3) time points.
Secondary outcome [2] 352462 0
Coping self-efficacy. Coping self-efficacy (CSE; Chesney, Chambers, Taylor, Johnson, & Folkman, 2003),
Timepoint [2] 352462 0
There are a total of four time points: baseline (T1), at the conclusion of the Cadet's first training exercise (T2), prior to the Cadet's second training exercise (T3), and at the conclusion of the Cadet's second training exercise (T4). The final time point is the primary time point of interest, however we also anticipate differences in change over time and group averages at intermediate (T2/T3) time points.
Secondary outcome [3] 352463 0
Professional support seeking. Cadet’s will be asked to indicate at longer-term follow-up whether they have sought support from the student counsellor or Chaplin over the course of their second-class training. This is a self-report question as part of a survey and does not involve data-linkage to medical records.
Timepoint [3] 352463 0
There are a total of four time points: baseline (T1), at the conclusion of the Cadet's first training exercise (T2), prior to the Cadet's second training exercise (T3), and at the conclusion of the Cadet's second training exercise (T4). The final time point is the primary time point of interest, however we also anticipate differences in change over time and group averages at intermediate (T2/T3) time points.
Secondary outcome [4] 352464 0
Perceived instructor support (Rhoades, L., Eisenberger, R., & Armeli, S. 2001) - measures the perception of support from RMC instructors and a Cadet’s beliefs concerning the extent to which supervisors value their contributions and care about their well-being.
Timepoint [4] 352464 0
There are a total of four time points: baseline (T1), at the conclusion of the Cadet's first training exercise (T2), prior to the Cadet's second training exercise (T3), and at the conclusion of the Cadet's second training exercise (T4). The final time point is the primary time point of interest, however we also anticipate differences in change over time and group averages at intermediate (T2/T3) time points.
Secondary outcome [5] 352465 0
Leadership capability. The researchers will receive access to Cadet performance records at the end of second-class. Leadership capability is assessed by RMC training instructors. Instructors are trained to assess leadership capability during particular exercises where Cadets are given the opportunity to lead a group of their peers. Leadership capability is assessed using a few criteria including, but not limited to: (1) ability to confidently provide direction to peers, (2) capacity to effect changes to a plan, (3) ability to navigate an enemy encounter or ambush, (4) ability to care for, and consider, the needs of individual team members.
Timepoint [5] 352465 0
This information will be collected at the completion of second class when raw performance scores have been collated.
Secondary outcome [6] 352491 0
Reflection and rumination (Treynor, W., Gonzalez, R., & Nolen-Hoeksema) scale measuring the frequency of rumination and adaptive self-reflection
Timepoint [6] 352491 0
There are a total of four time points: baseline (T1), at the conclusion of the Cadet's first training exercise (T2), prior to the Cadet's second training exercise (T3), and at the conclusion of the Cadet's second training exercise (T4). The final time point is the primary time point of interest, however we also anticipate differences in change over time and group averages at intermediate (T2/T3) time points.
Secondary outcome [7] 352721 0
Academic performance
Timepoint [7] 352721 0
Raw academic performance scores will be provided to the researchers at the end of second class.
Secondary outcome [8] 352722 0
Foundation Warfighting. The researchers will received access to Cadet Foundation Warfighting scores at the end of second-class.. This is assessed by RMC training instructors and assesses Cadet's ability to apply skills, knowledge, and attitudes to plan a tactical response to a serial stimulating a warfighting dilemma.
Timepoint [8] 352722 0
A Foundation Warfighting score will be provided to researchers at the end of second class.
Secondary outcome [9] 389433 0
Command. Command is assessed by RMC training instructors and involves assessments of a Cadet's ability to lead a platoon during serials.
Timepoint [9] 389433 0
At the end of second-class, researchers will be provided the Command score by RMC.
Secondary outcome [10] 389434 0
Perceived instructor encouragement of self-reflective coping. A scale created for the purpose of the study assessing the extent to which Cadet perceived their instructor encouraging them to self-reflect on the stressor and stressor coping experience. This scale was expected to mediate condition effects on mental health outcomes.
Timepoint [10] 389434 0
Measured at T2 at the conclusion of Cadets' first training exercise, T3 prior to the Cadets' second training exercise, and T4 at the conclusion of the Cadets' second training exercise.

Eligibility
Key inclusion criteria
Cadets commencing second class in January 2019 at the Royal Military College will be invited to participate in the research. Similarly, all RMC instructors instructing second class will be invited to participate.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Second class Cadets will be the group of interest and we are unaware of who will be in which platoons when those platoons are being allocated to groups. Groups are allocated by an off-site person who has no knowledge of the persons in each platoon. Instructors therefore associated with training these platoons will then receive their allocation by association with that platoon.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The lead researcher will randomly allocate a platoon to a condition via a coin-toss. By association the instructors will then be also randomly allocated to groups. For example, if platoon A is allocated to the control condition and the instructors of platoon A are Mark, Kim and Ben then these instructors will receive the control. Whereas, if platoon B is allocated via coin toss to the intervention and the associated instructors are Jim, James, and Jenny then these instructors will receive the intervention training.

Dr Crane is unaware of which RMC instructors are considered better performers. RMC staff are typically aware of the performance of certain instructors and would therefore not be unbiased in their allocation of instructors to groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The longitudinal, group-randomised controlled, design proposed will allow the research team to investigate the effect of instructors trained to integrate Mental Fitness Training approaches into typical field exercises and lessons on the resilience and performance of RMC Cadets.
A group-randomized controlled trial involves the random allocation of eight platoons into two groups. Randomization by platoon is a common practice in military training trials in order to avoid cross-contamination of training content. All RMC Cadets (N=250) in second-class, commencing January 2019, will receive the self-reflection activities involving an initial 40-minute training brief and then 20 minutes of guided self-reflection writing activities each week for five weeks.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will conduct a generalized linear mixed model (GLMM) to determine whether platoon membership explains a significant amount of variance in the outcome variables. If platoon does impact the outcome measures, the analysis will proceed using GLMM to account for platoon membership in the analysis. If platoon membership is not related to outcomes (as has been the case in previous years), the longitudinal changes between the intervention conditions will be tested using generalized estimating equation (GEE) models. GEE emphasizes the measurement of group change over time whilst accounting for within-subject variance (Hubbard, et al., 2010). Change over time will be modelled with a categorical time coefficient that enables the measurement of nonlinear change in symptoms over time. Pairwise comparisons will be derived from the marginal models, seeking to test specific interaction effects, such as specific comparison between intervention conditions within specific time points. Estimates such as Cohens d will be calculated to convey the magnitude of both within and between-subjects effects.
All analyses will be conducted using SPSS version 22 or MPLUS. Power calculations have been conducted to confirm that given the plausible sample size the study is powered to detect absolute differences in the primary outcomes. Power analyses were conducted using “longpower” in R.
To address missing values data, replacement values will be generated for all dependent variables following an analysis of missing values assumptions (Little, et al., 2012).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2019
Actual
14/02/2019
Date of last participant enrolment
Anticipated
31/01/2019
Actual
15/02/2019
Date of last data collection
Anticipated
31/07/2019
Actual
13/06/2019
Sample size
Target
212
Accrual to date
Final
168
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 24233 0
2612 - Campbell

Funding & Sponsors
Funding source category [1] 300835 0
University
Name [1] 300835 0
Macquarie University
Country [1] 300835 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
Building C3A, Department of Psychology
Macquarie University
North Ryde, NSW, 2109
Country
Australia
Secondary sponsor category [1] 300380 0
Government body
Name [1] 300380 0
Royal Military College
Address [1] 300380 0
Cnr Harrison Rd and Robert Campbell Rd
Campbell, ACT, 2612
Australia
Country [1] 300380 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301604 0
The Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC)
Ethics committee address [1] 301604 0
Ethics committee country [1] 301604 0
Australia
Date submitted for ethics approval [1] 301604 0
22/10/2018
Approval date [1] 301604 0
13/02/2019
Ethics approval number [1] 301604 0

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

Contacts
Principal investigator
Name 87526 0
Dr Monique Crane
Address 87526 0
Department of Psychology
Building C3A, 4-First Walk
Level 5, rm 509
Macquarie University
North Ryde, NSW, 2019
Country 87526 0
Australia
Phone 87526 0
+61 400920862
Fax 87526 0
Email 87526 0
[email protected]
Contact person for public queries
Name 87527 0
Monique Crane
Address 87527 0
Department of Psychology
Building C3A, 4-First Walk
Level 5, rm 509
Macquarie University
North Ryde, NSW, 2019
Country 87527 0
Australia
Phone 87527 0
+61 400920862
Fax 87527 0
Email 87527 0
[email protected]
Contact person for scientific queries
Name 87528 0
Monique Crane
Address 87528 0
Department of Psychology
Building C3A, 4-First Walk
Level 5, rm 509
Macquarie University
North Ryde, NSW, 2019
Country 87528 0
Australia
Phone 87528 0
+61 400920862
Fax 87528 0
Email 87528 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
Data on military personnel is restricted and cannot be shared in the public domain. Moreover, the conditions of the ethical approval currently restrict sharing.


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.