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Trial registered on ANZCTR


Registration number
ACTRN12621001373864
Ethics application status
Approved
Date submitted
28/09/2020
Date registered
11/10/2021
Date last updated
11/10/2021
Date data sharing statement initially provided
11/10/2021
Date results provided
11/10/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psychological First Aid Training of Nurses For Disaster Preparedness: A Non-Equivalent Control Group Study
Scientific title
Psychological First Aid Training of Nurses For Disaster Preparedness: A Non-Equivalent Control Group Study
Secondary ID [1] 297235 0
None
Universal Trial Number (UTN)
U1111-1258-7647
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety
 319199 0
Post-traumatic stress disorder (PTSD) 323502 0
Poor psychological preparedness 323503 0
Condition category
Condition code
Mental Health 317166 317166 0 0
Anxiety
Mental Health 317167 317167 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The psychological first aid (PFA) training programme was modified from the RAPID-PFA, which was developed by Johns Hopkins Center for Public Health Preparedness. The modified programme was nine hours long and was delivered over five weeks (the first four weeks were two hours long and the last week was 1 hour), with interactive didactic lectures, group discussions, and the addition of simulation simulated role-play exercises based on disaster scenarios relevant to the Palestinian situation. The core competencies of the modified and adopted RAPID-PFA training incorporated the five essential elements of immediate mass trauma intervention (safety, calming, self-and collective efficacy, connectedness, and hope).
The PFA trainer who was invited to conduct the training was a licensed psychologist from the organisation Médecins Sans Frontières/Doctors Without Borders (MSF), Doctors of the World, or World Vision, who had extensive experience as an emergency and trauma responder. The trainer attended the online version of RAPID-PFA to understand this version of PFA.
The study used a non-equivalent control group design with pre-and post-test. However, simple randomisation was used by drawing two hospitals to allocate the intervention arm, then the other three hospitals to form the control arm ((wait-listed)). To avoid contamination, nurses were allocated either to the intervention or control group by individual hospitals. The study included five hospitals in the Nablus and Ramallah cities in the West Bank, Palestine.
Some strategies used during the intervention to ensure fidelity: The researcher assessed whether participated nurses understood the intervention content and how relevant they thought the intervention was to their work (nursing day work), for example, follow-up questions and discussions. The researcher tracked attendance at each session and conducting a pre-posttest to assess their improvement following the intervention. Furthermore, the PFA training was delivered by the same trainer, which ensured training fidelity.
Intervention code [1] 318691 0
Treatment: Other
Comparator / control treatment
Participating nurses in this arm were not included in the Psychological First Aid (PFA) training, and the evaluations were performed based on their existing nursing education and professional experience, but they would be on a waitlist for the modified RAPID-PFA training after the study.
The wait-list may receive the intervention at any time after the completion of the 5 week study when the resources become available.
Control group
Active

Outcomes
Primary outcome [1] 325248 0
Change in Nurses’ psychological preparedness for disaster is assessed by Psychological Preparedness for Disaster Threat Scale (PPDTS) (Zulch et al., 2012).
Timepoint [1] 325248 0
At baseline and after five weeks (Intervention duration). Using the above scale.
Secondary outcome [1] 387331 0
Change in Nurses' self-efficacy as assessed using General Self-Efficacy Scale (GSE). GSE contains 10 questions on a 4-point scale (1 = not at all true to 4 = exactly true) (Schwarzer and Jerusalem, 1995).
Timepoint [1] 387331 0
At baseline and after five weeks (Intervention duration). Using the above scale.
Secondary outcome [2] 395327 0
Change in Nurses' self-esteem as assessed by Self-Esteem Scale (SES). The SES (Rosenberg, 1965) has 10 questions in a 4-point Likert scale (1 = strongly agree to 4 = strongly disagree).
Timepoint [2] 395327 0
At baseline and after five weeks (Intervention duration). Using the above scale.
Secondary outcome [3] 400597 0
Change in Nurses' dispositional optimism as assessed by the Life Orientation Test (LOT). The LOT (Scheier et al.,1994) has 10 questions on a 0 to 4 Likert scale (0 = strongly disagree to 4 = strongly agree).
Timepoint [3] 400597 0
At baseline and after five weeks (Intervention duration). Using the above scale.
Secondary outcome [4] 400598 0
Change in Nurses' trait Anxiety as assessed by State-trait Anxiety Inventory (STAI)(Spielberger et al., 1983), and the items are rated on a 4-point scale (From “Almost Never” to “Almost Always”).
Timepoint [4] 400598 0
At baseline and after five weeks (Intervention duration). Using the above scale.
Secondary outcome [5] 400599 0
Change in Nurses PTSD as assessed by PTSD Diagnostic Scale for DSM-5 (PDS-5). The PDS-5 (Foa et al., 2015) is a 24-item questionnaire with a 5-point Likert scale (0 = Not at all to 4 = severe).
Timepoint [5] 400599 0
At baseline and after five weeks (Intervention duration). Using the above scale.
Secondary outcome [6] 400600 0
Change in Nurses' PFA knowledge, attitude, and skills, as assessed by PFA scale developed by Everly et al. (2014) that aimed at 1) measuring knowledge (understanding PFA concepts) (ten items: four multiple choices and six true/false); 2) assessing skills in the application of PFA (perceived self-efficacy) (10 items); and 3) evaluating attitudes (self-confidence) in providing PFA (10 items). The items are structured in a 5-point Likert scale (1 = very unconfident to 5 = don't know; and 1 = very unprepared to 5 = don't know).
The used scale was one scale and has three dimensions (knowledge, attitude, and skills).
Timepoint [6] 400600 0
At baseline and after five weeks (Intervention duration). Using the above scale.

Eligibility
Key inclusion criteria
1. Nurses working in the Emergency Department or Critical care units or Trauma departments/units.
2. Minimum one year experience.
3. Full-time hospital work.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Statistical analysis was performed using SPSS, version 25. Descriptive statistics were used to summarise participant characteristics. Normality of the PPDTS distribution was evaluated with skewness and kurtosis from the Shapiro-Wilk test. The Alpha was set at the level of p < .05. Chi-square and Mann-Whitney U test were used to check for any significant group differences in demographics and outcome variables between the control and experiment groups at baseline.

The analysis considered ITT principle, then the fully conditional specification (FCS) method (creating several "complete" sets of data) with the imputations by the number of the percentage of missing values was performed. During each imputation, the missing values were imputed and at the end of all imputations, the values were averaged together to estimate the variance of the missing values. Finally, the required number of imputed datasets was generated.
Generalized Estimating equations (GEE) model was used to assess any changes in the outcome variables between the control and experiment groups across the pre- and post-test study period (i.e. group by time interaction effect).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/06/2019
Date of last participant enrolment
Anticipated
Actual
14/06/2019
Date of last data collection
Anticipated
Actual
8/08/2019
Sample size
Target
168
Accrual to date
Final
168
Recruitment outside Australia
Country [1] 23016 0
Palestinian Territory, Occupied
State/province [1] 23016 0
West Bank

Funding & Sponsors
Funding source category [1] 301790 0
Hospital
Name [1] 301790 0
An Najah National University Hospital
Country [1] 301790 0
Palestinian Territory, Occupied
Funding source category [2] 308580 0
Hospital
Name [2] 308580 0
Rafedia Hospital
Country [2] 308580 0
Palestinian Territory, Occupied
Primary sponsor type
University
Name
The Hong Kong Polytechnic University
Address
Hong Chong Rd, Hung Hom, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 301533 0
University
Name [1] 301533 0
An Najah National University
Address [1] 301533 0
Rafedia, Nablus, West Bank
P.O.BOX 7
Country [1] 301533 0
Palestinian Territory, Occupied

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302502 0
Human Subjects Ethics Sub-committee (HSESC) at The Hong Kong Polytechnic University
Ethics committee address [1] 302502 0
Ethics committee country [1] 302502 0
Hong Kong
Date submitted for ethics approval [1] 302502 0
10/01/2019
Approval date [1] 302502 0
29/01/2019
Ethics approval number [1] 302502 0
HSEARS20190118001
Ethics committee name [2] 306990 0
Institutional Review Board at An-Najah National University
Ethics committee address [2] 306990 0
Ethics committee country [2] 306990 0
Palestinian Territory, Occupied
Date submitted for ethics approval [2] 306990 0
01/05/2019
Approval date [2] 306990 0
14/05/2019
Ethics approval number [2] 306990 0
IRB(12)April2019

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

Contacts
Principal investigator
Name 90434 0
Dr Vico Chiang
Address 90434 0
School of Nursing, The Hong Kong Polytechnic University, Hong Chong Rd, Hung Hom, Hong Kong
Country 90434 0
Hong Kong
Phone 90434 0
+852 2766 6683
Fax 90434 0
+852 2364 9663
Email 90434 0
[email protected]
Contact person for public queries
Name 90435 0
Vico Chiang
Address 90435 0
School of Nursing, The Hong Kong Polytechnic University, Hong Chong Rd, Hung Hom, Hong Kong
Country 90435 0
Hong Kong
Phone 90435 0
+852 2766 6683
Fax 90435 0
+852 2364 9663
Email 90435 0
[email protected]
Contact person for scientific queries
Name 90436 0
Vico Chiang
Address 90436 0
School of Nursing, The Hong Kong Polytechnic University, Hong Chong Rd, Hung Hom, Hong Kong
Country 90436 0
Hong Kong
Phone 90436 0
+852 2766 6683
Fax 90436 0
+852 2364 9663
Email 90436 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9299Informed consent formSaid, N. B. (2020). Psychological First Aid Training of Nurses for Disaster Preparedness: A non-equivalent control group study [Unpublished doctoral dissertation]. The Hong Kong Polytechnic University. Hong Kong. [email protected] 376844-(Uploaded-28-09-2020-04-51-49)-Study-related document.doc



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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