Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000225910
Ethics application status
Approved
Date submitted
1/03/2011
Date registered
2/03/2011
Date last updated
20/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
In community based mental health workers, does an open-label four session communication skills programme change the rate of client or patient aggression experienced by the health care workers?"
Scientific title
In community based mental health workers, does an open-label four session communication skills programme change the rate of client or patient aggression experienced by the health care workers?"
Secondary ID [1] 259707 0
Nil
Universal Trial Number (UTN)
U1111-1119-6812
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient Aggression 261281 0
Post traumatic stress 261282 0
Workplace injury 261283 0
Condition category
Condition code
Mental Health 259430 259430 0 0
Studies of normal psychology, cognitive function and behaviour
Injuries and Accidents 259431 259431 0 0
Other injuries and accidents
Public Health 259438 259438 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four one hour, weekly group sessions providing education communication skills. These sessions are completely scripted. All demonstrations will be filmed and available on DVD. For the purposes of this trial, the intervention will be delivered by CG and NS (psychiatrist and psychologist). However, the intervention is designed to be delivered by lay people.

The sessions will be delivered over a period of four weeks.

Session one: basic skills.
You are seen as a professional member of team.
Appearance (Neat, clean). Avoid distractions (gum, texting, phone calls to voice message).
Non verbal: pleasant, smiling, appropriate variation.
Gaining a working relationship.
Follow their interests.
Task listening neutral topics.
Describing tasks – what I'm going to do, where I am.
Gaining agreement from client it is “OK” to do this.
Session two: Self care.
Working with people with disabilities can be stressful.
Difference between friendship and caregiving.
Need to always consider clients best interests.
No exploitation
Keeping conversations secret. Not gossiping. When to break secrecy (around risks).
Keeping your family life secret.
Dealing with emotions.
Talking to supervisor or in supervision group.
Sleep, diet, exercise
Relaxation. – session finishes with practising relaxation.
Session three: Difficulties with working.
Caregiving can require we say “no” or do things that are quite private.
Dealing with intimate tasks.
Reinforce need to describe and get agreement.
Respectful, friendly, non judgemental.
“Let's get this right”
Exposure, privacy.
Task – practising agreement to clean hands.
Saying “no”.
Specific issue.
How it affects me and how it affects client.
Getting agreement forward.
Session four – warnings things will go wrong.
You can't help anyone if you are not safe yourself.
Reading non verbal clues discomfort.
Reacting... verbally and non verbally.
Agitation – talking down.
When to leave, Who to call.
Intervention code [1] 264135 0
Other interventions
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262238 0
Change in NZ version of Perception of Patient Aggression scale (POPAS)
Timepoint [1] 262238 0
Pre intervention, post intervention completion, one month, three months.

(Note that all participants have monthly outcome measures: the months used will depend on the timing of the interventions)
Secondary outcome [1] 273368 0
Impact of Events Scale - Revised (IES-R)

Kessler 10 scale (K10)
Timepoint [1] 273368 0
Pre intervention, post intervention,completion one month, three months

Eligibility
Key inclusion criteria
Working with clients in the community with a mental health diagnosis.
Ability to speak English and give consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Working inside a hospital.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Non governmental organizations will be contacted to obtain permission to meet with their teams. Study group will present protocol to teams & consent obtained. Intervention is to be delivered to group. The instrument was then delivered to all participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2011
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
1/11/2012
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
100
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 3249 0
New Zealand
State/province [1] 3249 0

Funding & Sponsors
Funding source category [1] 264590 0
Charities/Societies/Foundations
Name [1] 264590 0
James Hume Memorial Fund
Country [1] 264590 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
P O Box 913
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 263730 0
Charities/Societies/Foundations
Name [1] 263730 0
James Hume Fund
Address [1] 263730 0
Department of Psychological Medicine
Dunedin School of Medicine
P O Box 913
Dunedin 9054
Country [1] 263730 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260583 0
Lower South Regional Ethics Committee
Ethics committee address [1] 260583 0
Ethics committee country [1] 260583 0
New Zealand
Date submitted for ethics approval [1] 260583 0
15/03/2011
Approval date [1] 260583 0
01/05/2011
Ethics approval number [1] 260583 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1811 1811 0 0
/AnzctrAttachments/336614-1-s2.0-S0020748914000236-main.pdf

Contacts
Principal investigator
Name 32292 0
Dr Nicola Swain
Address 32292 0
Department of Psychological Medicine,
Dunedin School of Medicine,
University of Otago,
P. O. Box 913
Dunedin 9054
New Zealand.
Country 32292 0
New Zealand
Phone 32292 0
+6434640777
Fax 32292 0
Email 32292 0
[email protected]
Contact person for public queries
Name 15539 0
Christopher Gale
Address 15539 0
Department of Psychological Medicine
Dunedin School of Medicine
P O Box 913
Dunedin 9054
Country 15539 0
New Zealand
Phone 15539 0
+64 3 474 0999 x7372
Fax 15539 0
Email 15539 0
[email protected]
Contact person for scientific queries
Name 6467 0
Christopher Gale
Address 6467 0
Department of Psychological Medicine
Dunedin School of Medicine
P O Box 913
Dunedin 9054
Country 6467 0
New Zealand
Phone 6467 0
+64 3 474 0999 x7372
Fax 6467 0
Email 6467 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
No additional documents have been identified.