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Trial registered on ANZCTR


Registration number
ACTRN12617000901303
Ethics application status
Approved
Date submitted
13/06/2017
Date registered
19/06/2017
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A 12 week pilot study targeted for adult consumers within a community mental health rehabilitation setting to implement a Personal Safety Tool for self-management and crisis management.
Scientific title
A pilot study on the use of a Personal Safety Tool for self-management and crisis management within a clinical mental health rehabilitation setting.
Secondary ID [1] 292188 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder 303684 0
Anxiety 303685 0
Schizophrenia 303686 0
Personality Disorder 303687 0
Dissociative identity disorder 303688 0
Obsessive Compulsive Disorder 303689 0
Post-Traumatic Stress Disorder 303690 0
Condition category
Condition code
Mental Health 303050 303050 0 0
Psychosis and personality disorders
Mental Health 303061 303061 0 0
Schizophrenia
Mental Health 303062 303062 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Project Leads to develop a Personal Safety Tool targeted for a community mental health setting. The Personal Safety Tool aims for participants to work collaboratively with Project Leads to identify what the participant is like when they are well, what situations cause them distress and the signals of their distress. The Personal Safety Tool will offer practical suggestions for self-soothing and calming strategies during crisis situations.

The Personal Safety Tool has been developed as a 3 page paper document which will be provided to participants to utilise at the community mental health rehabilitation program, at their home and in the community.

A range of sensory tools and strategies will be offered to participants to explore when completing their Personal Safety Tool with Project Leads support and supervision. This will include low risk calming/self-soothing and alerting strategies which targets participant senses. Project Leads are trained in implementing sensory modulation, which is the ability to assist the participant to self-regulate by providing an opportunity to participate in activities and behaviours that engage their senses. Project Leads ensure to adhere to SA Health, Northern Mental Health Services Sensory Modulation local procedure guidelines to ensure therapy is offered and facilitated in a safe manner.

Project Leads (Occupational Therapists) with 4 years mental health experience will be delivering the intervention with Project Sponsor/Team Leader support with minimum of 10 years’ experience in mental health.

The mode of delivery will be face to face in a public community mental health rehabilitation service. Contact will be made individually. Confidentiality requirements will be adhered to through the option to meet in a private meeting room.

The intervention will be delivered over a 12 week period. Weekly face to face contact will be delivered as well as phone calls for 15-30 minutes to support semi-structured debriefing, evaluation and follow up.

The location will be at a public community mental health rehabilitation service. Contact will be made individually.

The Personal Safety Tool will be completed collaboratively with participants and Project Leads to ensure individual needs are considered (e.g. participants early warning signs, triggers and individual sensory based coping strategies to manage in crisis). The Personal Safety Tool can be updated and amended at any time during the pilot study to meet changing needs of participants.

The Personal Safety Tool offers opportunity for consumers to add additional information which is individualised to their preferences and needs e.g. ‘other' sections to make additional comments.

Ensuring the Personal Safety Tool is individualised is important to ensure the document is client centred, meaningful and meets Mental Health and National Safety and Quality Standards (consumer and carer participation standard). It additionally aligns with recovery, sensory modulation and trauma informed care and practice principles.

The Personal Safety Tool pilot study will commence implementation in July 2017. This initial stage of implementation will be collaboratively completing a Personal Safety Tool with participants and support from Project Leads at the community mental health rehabilitation service. The rest of the implementation phase will be over the following 12 week period.

Project Leads will be determining adherence of the Personal Safety Tool use through weekly debriefing (e.g. phone calls and face to face meetings). Consent forms will highlight to participants their rights to opt in and opt out of pilot study.

Project Leads have established therapeutic rapport and this will likely support opportunities for open communication around adherence and fidelity and how to mitigate any concerns expressed by participants.
Intervention code [1] 298346 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302423 0
Composite Primary Outcome. Self-management assessed by the Sensory Modulation Crisis Management self-rating scale and Questionnaire specifically designed for this study.
Timepoint [1] 302423 0
12 weeks
Secondary outcome [1] 335953 0
Emergency department presentations assessed by statistics in emergency department contacts.
Timepoint [1] 335953 0
12 months
Secondary outcome [2] 336063 0
Mental health hospital re-admissions assessed by statistics in inpatient presentations
Timepoint [2] 336063 0
12 months
Secondary outcome [3] 336143 0
Length of care in mental health inpatient admissions assessed by statistics in inpatient presentations
Timepoint [3] 336143 0
12 months
Secondary outcome [4] 336145 0
Phone contacts to mental health crisis services assessed by review of mental health medical records/community based information system database
Timepoint [4] 336145 0
12 months

Eligibility
Key inclusion criteria
Adult 18-65years
Mental Health Diagnosis including:
• Borderline Personality Disorder
• Anxiety
• Schizophrenia
• Personality Disorder
• Dissociative identity disorder
• Obsessive Compulsive Disorder
• Post-Traumatic Stress Disorder

Registered consumer with Northern Community Mental Health Services
Registered Consumer with the Northern Clinical Psychosocial Rehabilitation Program
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor judgement / insight
Cognitive impairment impacting on decision making / ability to make informed consent
Decline mental health symptoms/relapse in mental health

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Nil requirements for sample size to achieve study objectives, desirable sample size 10-20 participants
Pre and post evaluation measures will be used to evaluate data, in the form of self-rating scales.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/06/2017
Actual
1/09/2017
Date of last participant enrolment
Anticipated
30/06/2017
Actual
15/09/2017
Date of last data collection
Anticipated
29/09/2017
Actual
22/12/2017
Sample size
Target
15
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 8349 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 16420 0
5112 - Elizabeth Vale
Recruitment postcode(s) [2] 23217 0
5113 - Elizabeth Park

Funding & Sponsors
Funding source category [1] 296725 0
Government body
Name [1] 296725 0
Government of South Australia, SA Health, Northern Adelaide Local Health Network, Northern Mental Health Services, Northern Clinical Psychosocial Rehabilitation Program 'Club 84'
Country [1] 296725 0
Australia
Primary sponsor type
Individual
Name
Michelle Oliver
Address
Northern Clinical Psychosocial Rehabilitation Program 'Club 84'
84 Yorktown Road, ELIZABETH PARK, S.A., 5113
Country
Australia
Secondary sponsor category [1] 295696 0
None
Name [1] 295696 0
Address [1] 295696 0
Country [1] 295696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297953 0
Human Research Ethic Committee (HREC)
Ethics committee address [1] 297953 0
Ethics committee country [1] 297953 0
Australia
Date submitted for ethics approval [1] 297953 0
19/06/2017
Approval date [1] 297953 0
03/08/2017
Ethics approval number [1] 297953 0
Q20170609 HREC/17/TQEH/132

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2857 2857 0 0
/AnzctrAttachments/373125-A_Francis_A_Daw_PST Project Description.pdf (Protocol)
Attachments [2] 2858 2858 0 0
/AnzctrAttachments/373125-Approval Letter - Q20170609 - DawFrancis.pdf (Ethics approval)
Attachments [3] 2859 2859 0 0
/AnzctrAttachments/373125-Francis Daw_PST pilot study participant consent form.pdf (Participant information/consent)
Attachments [4] 2860 2860 0 0
/AnzctrAttachments/373125-PST Project Study PICF.pdf (Participant information/consent)

Contacts
Principal investigator
Name 75558 0
Ms Amily Daw
Address 75558 0
Northern Clinical Psychosocial Rehabilitation Program 'Club 84'
84 Yorktown Road, ELIZABETH PARK, S.A., 5113
Country 75558 0
Australia
Phone 75558 0
+61 8 7485 4500
Fax 75558 0
+61 8 7485 4511
Email 75558 0
amily.daw@sa.gov.au
Contact person for public queries
Name 75559 0
Anna Francis
Address 75559 0
Northern Clinical Psychosocial Rehabilitation Program 'Club 84'
84 Yorktown Road, ELIZABETH PARK, S.A., 5113
Country 75559 0
Australia
Phone 75559 0
+61 8 7485 4500
Fax 75559 0
+61 8 7485 4511
Email 75559 0
anna.francis@sa.gov.au
Contact person for scientific queries
Name 75560 0
Anna Francis
Address 75560 0
Northern Clinical Psychosocial Rehabilitation Program 'Club 84'
84 Yorktown Road, ELIZABETH PARK, S.A., 5113
Country 75560 0
Australia
Phone 75560 0
+61 8 7485 4500
Fax 75560 0
+61 8 7485 4511
Email 75560 0
anna.francis@sa.gov.au

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.