Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617001148369
Ethics application status
Approved
Date submitted
3/08/2017
Date registered
7/08/2017
Date last updated
26/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot randomised control trial assessing a web-based training program on paediatric medical traumatic stress and trauma-informed care for emergency department staff.
Scientific title
A pilot randomised control trial assessing emergency department staff improvement in knowledge of paediatric medical traumatic stress and trauma-informed care following a web-based training program.
Secondary ID [1] 292450 0
NIL
Universal Trial Number (UTN)
U1111-1199-3787
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric medical traumatic stress 304060 0
Condition category
Condition code
Public Health 303386 303386 0 0
Health promotion/education
Mental Health 303621 303621 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a web-based training program for emergency department staff (Peadiatric medical traumatic stress and trauma-informed care principles training for emergency department staff). The training program is comprised of a single module 15 minute evidenced based educational video. Participants in the intervention group can complete this training in one session or they can choose to complete the training in smaller blocks of time. Participants can access the training until training is complete.
Topics covered in the training include: peadiatric medical traumatic stress following childhood injuries and the signs, symptoms and risk and prognostic factors; and the principles and strategies of trauma-informed care that can be used by emergency department staff to minimise distress and facilitate social support for these children and families. Adherence will be monitored and recorded via the training website which records the duration of time the video was played.
Note: this study assesses a training program aimed at improving medical practitioner knowledge of paediatric medical traumatic stress and is not a assessing a treatment for this condition.
Intervention code [1] 298808 0
Treatment: Other
Comparator / control treatment
1-month, no treatment, waitlist control condition.
Participants in the waitlist control conditions will complete measures at all three time points without receiving any intervention. Following completion of measures at all three time points participants in the waitlist control condition will be given access to the training intervention.
Control group
Active

Outcomes
Primary outcome [1] 302851 0
Emergency staff knowledge of paediatric medical traumatic stress as assessed by the knowledge scale of the Psychosocial Care Survey (Alisic et al., 2016). This scale includes 7 questions assessing knowledge of paediatric medical traumatic stress in injured children.
Timepoint [1] 302851 0
The psychosocial care survey will be completed by both the intervention and control groups at the following time points:
Baseline (pre-intervention)
1 week follow up (intervention group - 1 week post intervention; control group - 1 week post baseline)
1 month follow up (intervention group - 1 month post intervention; control group - 1 month post baseline)
Secondary outcome [1] 337239 0
Dropout rate.
The dropout rate will be assessed comparing the number of participants who complete the baseline measures to the number of participants who complete measures at the 1 week and 1 month follow up.
Timepoint [1] 337239 0
1 week follow up (intervention group - 1 week post intervention; control group - 1 week post baseline)
1 month follow up (intervention group - 1 month post intervention; control group - 1 month post baseline)
Secondary outcome [2] 337240 0
Measures of Feasibility and Acceptability
Participants will be asked questions relating to the training. The feasibility and acceptability questionnaire designed for this study includes four multiple choice questions and two open answer questions to assess satisfaction with the intervention, perceived confidence in incorporating the training into practice following the intervention and perceived usefulness of the intervention.
Timepoint [2] 337240 0
1 week follow up (intervention group - 1 week post intervention) - (intervention group only)

Eligibility
Key inclusion criteria
Nurses and physicians working in emergency care in Australia and New Zealand, who are fluent in english and have access to the internet.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
There is no further exclusion criteria.

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)
Participants will be determined to be eligible to participate in the trial via response to an online form indicating they meet inclusion criteria prior to being allocated to either the intervention or control group or providing additional demographic or baseline data. Following confirmation of eligibility the researcher can access the next allocation via a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned at 1:1 allocation using blocked randomization procedures with randomly permuted block sizes of 2, 4 and 6 the intervention group or a waitlist control group. The randomization sequence will be created using Stata 9.0 (StataCorp, College Station, TX) statistical software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention-to-treat analysis will be conducted (data from all randomised participants will be included in analysis; multiple imputation will be applied to account for missing data; post randomisation exclusions will only be applied to participants who dropout prior to baseline assessment and intervention).
To assess group differences in changes in emergency department staff’s knowledge of paediatric medical traumatic stress across time points (i.e., pre-intervention, post-intervention, and 1 month follow-up), analyses of variance (ANOVA) will be conducted.
To assess the feasibility and acceptability of this brief training to ED staff descriptive statistics will be conducted to examine responses to the 4 feasibility and acceptability questions. In addition a qualitative analysis of the themes of 2 free text questions will be conducted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/04/2017
Date of last participant enrolment
Anticipated
30/09/2017
Actual
Date of last data collection
Anticipated
1/10/2017
Actual
Sample size
Target
80
Accrual to date
71
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 9082 0
New Zealand
State/province [1] 9082 0

Funding & Sponsors
Funding source category [1] 297017 0
Government body
Name [1] 297017 0
Australian Research Training Program Scholarship, Department of Education and Training
Country [1] 297017 0
Australia
Funding source category [2] 297082 0
University
Name [2] 297082 0
Monash University, Faculty of Medicine, Nursing and Health Sciences
Country [2] 297082 0
Australia
Funding source category [3] 297162 0
Government body
Name [3] 297162 0
Early Career Fellowship (#1090229), National Health and Medical Research Council
Country [3] 297162 0
Australia
Primary sponsor type
Individual
Name
Dr Eva Alisic
Address
Monash University Accident Research Centre
Monash University
Clayton
Victoria 3800
Country
Australia
Secondary sponsor category [1] 296086 0
Individual
Name [1] 296086 0
Claire Hoysted
Address [1] 296086 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Wellington Road
Clayton 3800
Victoria
Country [1] 296086 0
Australia
Other collaborator category [1] 279657 0
Individual
Name [1] 279657 0
Dr Laura Jobson
Address [1] 279657 0
School of Psychological Sciences
Building 17
18 Innovation Walk
Monash University
Wellington Road
Clayton 3800
Victoria
Country [1] 279657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298202 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 298202 0
Ethics committee country [1] 298202 0
Australia
Date submitted for ethics approval [1] 298202 0
20/01/2017
Approval date [1] 298202 0
23/01/2017
Ethics approval number [1] 298202 0
2017-0626-10807

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

Contacts
Principal investigator
Name 76318 0
Dr Eva Alisic
Address 76318 0
Monash University Accident Research Centre
Monash University
Clayton 3800
Victoria
Country 76318 0
Australia
Phone 76318 0
+61 3 9905 4371
Fax 76318 0
Email 76318 0
[email protected]
Contact person for public queries
Name 76319 0
Claire Hoysted
Address 76319 0
School of Psychological Sciences,
Monash University
Clayton 3800
Victoria
Country 76319 0
Australia
Phone 76319 0
+61402772620
Fax 76319 0
Email 76319 0
[email protected]
Contact person for scientific queries
Name 76320 0
Claire Hoysted
Address 76320 0
School of Psychological Sciences,
Monash University
Clayton 3800
Victoria
Country 76320 0
Australia
Phone 76320 0
+61402772620
Fax 76320 0
Email 76320 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA pilot randomized controlled trial evaluating a web-based training program on pediatric medical traumatic stress and trauma-informed care for emergency department staff.2019https://dx.doi.org/10.1037/ser0000247
N.B. These documents automatically identified may not have been verified by the study sponsor.