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Trial registered on ANZCTR


Registration number
ACTRN12620000139976
Ethics application status
Approved
Date submitted
22/01/2020
Date registered
12/02/2020
Date last updated
27/10/2021
Date data sharing statement initially provided
12/02/2020
Date results provided
27/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Simulation training to manage challenging behaviours in children with autism.
Scientific title
Simulation-based education for staff managing aggression and high-risk behaviours of children with autism spectrum disorder in the hospital setting: A pilot and feasibility study of a cluster randomized controlled trial.
Secondary ID [1] 300322 0
Nil known
Universal Trial Number (UTN)
U1111-1246-9993
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
high-risk behaviour 315929 0
aggression 315930 0
autism 316060 0
Condition category
Condition code
Mental Health 314201 314201 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Simulation-based education for staff in managing aggressive and high-risk behaviours of children with autism spectrum disorder (ASD) in the hospital setting.

Staff training programs designed to teach best practice principles in the management of clinical aggression in paediatric acute care settings is warranted however evidence on training effects in general hospital settings is scant. There are a number of reviews of aggression management training programs in the psychiatric and mental health settings however the results cannot be generalised to the acute setting or further extrapolated to the paediatric setting due to the different types of care provided in each facility and prior training of staff. In addition, aggression management training programs designed for nursing staff working with children with neurodisabilities are rarely described in the literature. Simulation training may be an effective educational tool to practice de-escalation skills in a high fidelity situation. The benefit of simulation-based education for communication skills has been shown to improve patient safety in a number of studies. There is a paucity of literature in the use of simulation-based education to teach de-escalation communication techniques to staff working with children and young people, particularly those with ASD, in the acute care setting.

The training intervention will consist of two components.
1. A web-based learning package, developed using ArticulateTM software, about management of challenging behaviours in children and young people with autism (with and without intellectual disability (ID) ) in the hospital setting as pre-reading. The learning package was developed by an advanced practice nurses who specialises in neurodevelopmental disabilities and has extensive education and training experience. The content was reviewed by three health care clinicians who are autism experts with revisions made prior to commencement of the study. The online learning package has been designed to increase learner’s knowledge about autism. It provides tips on how to communicate with children with autism, especially when they are scared, frustrated or angry. It is estimated that it will take learners about 30 minutes to complete. The package consists of one module and includes short case studies with questions and answers to apply knowledge learnt within the training module. A weblink to the online package is sent to participants via email. Study participants complete the online learning package individually during work hours but prior to the simulation training. Participants will be reminded via email each week for three weeks to complete the package and the surveys during the study period. Nurse educators for the wards participating in the study will also follow up with study participants, reminding them to complete the training during the study period.

2. This will be followed by a 1.5 hour simulation-based group education session to manage challenging behaviours in an adolescent with autism including two separate simulation exercises each followed by a facilitated reflective debrief which explores what the participants did well, what were the challenges and what they will do differently next time. The training will be conducted in the hospital Simulation Centre, conducted by the Simulation Faculty and Code Grey Coordinator with an actor playing the role of the patient. The simulation exercises will be recorded using SportstecTM software. The Simulation Faculty staff are all highly trained and experienced in delivering simulation training. The Code Grey Coordinator is the hospital lead for aggression management and is highly experienced in aggression management procedures and training. The simulation-based training will be delivered twice to enable participants to attend a training session that is scheduled at a time most suitable to them.
Intervention code [1] 316601 0
Behaviour
Comparator / control treatment
Participants allocated to the comparator/control treatment in this study will only receive a web-based learning package in the same format offered to the intervention group participants.

Control group
Active

Outcomes
Primary outcome [1] 322584 0
The study will be judged feasible if the following criteria are met:

1. Randomisation: more than 10% recruitment rate from ward staff. A total of 160 staff from the two selected wards will be eligible to participate in the study. We aim to recruit 10 staff to each arm of the study.
2. Completion: Less than 20% attrition rate with survey completion rate of at least 80%; Focus group participation rate of at least 50% of total participants
3. Acceptability: High acceptability of the intervention among participants as indicated by 80% of scores 4 (good) out of 5 or higher in survey data
4. Data collection: follow-up survey response rate of at least 30% with acceptability and confidence levels maintained; Ward data collection rate of at least 80% of total shifts during study time in each ward
5. Low contamination from intervention participants as evidenced by participant report

Instrument: Pre-/Post-/Follow-up surveys designed specifically for this study. Survey includes “Confidence in Coping with Patient Aggression Instrument” (Thackrey, 1987), short answer questions and free text to assess: self-perceived levels of confidence and competence in managing aggression in a young person with autism and intellectual disability and acceptability of the simulation and web-based education.
Timepoint [1] 322584 0
Study period is for 3 months from delivery of training intervention.
Secondary outcome [1] 378990 0
Secondary outcomes will provide data about the participants reactions and behaviour changes due to exposure to the training:
1. Confidence & Competence: 80% of participants reporting increased confidence levels and positive qualitative comments.

Instrument: Post-training/Follow-up surveys designed specifically for this study. Survey includes “Confidence in Coping with Patient Aggression Instrument” (Thackrey, 1987), short answer questions and free text to assess: self-perceived levels of confidence and competence in managing aggression in a young person with autism and intellectual disability and acceptability of the simulation and web-based education.

Timepoint [1] 378990 0
Immediately after and up to three months post-training.
Secondary outcome [2] 379974 0
2. Data collection: 80% reporting of number of Code Grey activations and the number of successful de-escalation episodes not requiring a Code Grey activation with description of context and outcome for each incident. Participant use of de-escalation skills during simulations using De-escalating Aggressive Behaviours Scale – English modified version (EMDABS).
Instruments:
a. De-escalating Aggressive Behaviours Scale – English modified version (EMDABS),
b. Linkage to hospital reports,
c. Ward data collection instrument developed for this study.
Timepoint [2] 379974 0
One month prior to training and up to three months post-training.

Eligibility
Key inclusion criteria
Clinical nurses who work in two general medical and surgical wards will be invited to participate in the study. Eligible nurses will be those who are responsible for providing direct clinical care for ward patients.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nurses from these wards are excluded if they are not responsible for direct patient care e.g. care coordinators, advanced practice nurses and nurses in charge of the shift.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation conducted once recruitment completed by researcher not involved in study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation - coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We plan to recruit 10 staff to each arm of the study. This sample size, based on our experiences in Phase 1 of this study, is a good size for a pilot and feasibility study to assess recruitment, contamination and data collection.

Primary outcomes: Percentages will be calculated, with 95% confidence intervals, to estimate recruitment, retention, outcomes survey response rate and the precision of those estimates. We will treat the Likert scores as categories and dichotomise the 11 and 5 point scale responses. Changes in confidence and competence will be compared statistically (Chi squared test) using before and after data, to compare the proportion of those who have high confidence at baseline between the two arms, and at follow-up.

Secondary outcomes: The Code Grey data and daily aggression data will be analysed using descriptive statistics, including descriptions of the clinical journey for children and young people who trigger more than one code grey response. We will report if aggression de-escalation attempts are recorded each shift on each ward as planned. The EMDABS data will be analysed using mean values and statistical significance tests used to compare results.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/11/2019
Date of last participant enrolment
Anticipated
Actual
15/11/2019
Date of last data collection
Anticipated
1/03/2020
Actual
1/03/2020
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15666 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 29075 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 304747 0
University
Name [1] 304747 0
Australian Government Research Training Program
Country [1] 304747 0
Australia
Funding source category [2] 304749 0
University
Name [2] 304749 0
Elizabeth and Vernon Puzey Scholarship
Country [2] 304749 0
Australia
Primary sponsor type
Hospital
Name
The Royal Children's Hospital, Melbourne
Address
50 Flemington Road,
Parkville, Victoria, 3052
Australia
Country
Australia
Secondary sponsor category [1] 305061 0
None
Name [1] 305061 0
Address [1] 305061 0
Country [1] 305061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305167 0
Research Ethics and Governance
Ethics committee address [1] 305167 0
Ethics committee country [1] 305167 0
Australia
Date submitted for ethics approval [1] 305167 0
23/08/2019
Approval date [1] 305167 0
01/11/2019
Ethics approval number [1] 305167 0
HREC/56684/RCHM-2019

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

Contacts
Principal investigator
Name 99466 0
Prof Fiona Newall
Address 99466 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052
Country 99466 0
Australia
Phone 99466 0
+61 9345 6716
Fax 99466 0
+61 9345 5606
Email 99466 0
fiona.newall@rch.org.au
Contact person for public queries
Name 99467 0
Marijke Mitchell
Address 99467 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052
Country 99467 0
Australia
Phone 99467 0
+61 9345 5898
Fax 99467 0
+61 9345 5871
Email 99467 0
marijke.mitchell@rch.org.au
Contact person for scientific queries
Name 99468 0
Marijke Mitchell
Address 99468 0
The Royal Children's Hospital
50 Flemington Road
Parkville, Victoria 3052
Country 99468 0
Australia
Phone 99468 0
+61 9345 5898
Fax 99468 0
+61 9345 5871
Email 99468 0
marijke.mitchell@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6519Study protocolMitchell MJ, Newall FH, Sokol J, Williams KJ. Simulation-Based Education for Staff Managing Aggression and Externalizing Behaviors in Children With Autism Spectrum Disorder in the Hospital Setting: Pilot and Feasibility Study Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc [Internet]. 2020 [cited 2020 Jun 11]; 9(6):[e18105 p.]. Available from: http://www.researchprotocols.org/2020/6/e18105/.https://www.researchprotocols.org/2020/6/e18105/ marijke.mitchell@rch.org.au
6520Informed consent form  marijke.mitchell@rch.org.au
6521Ethical approval  marijke.mitchell@rch.org.au



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.