Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000241033
Ethics application status
Approved
Date submitted
23/03/2010
Date registered
23/03/2010
Date last updated
31/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot project investigating the feasibility and effects of a 6 month peer support program commencing 3 months prior to discharge from a specialist first-episode psychosis treatment center
Scientific title
A pilot study examining whether or not the provision of a 6 month peer support program commencing 3 months prior to discharge from a specialist first-episode psychosis treatment center can improve treatment adherence and other outcomes among young people
Secondary ID [1] 1536 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First-episode psychosis 257006 0
Condition category
Condition code
Mental Health 257169 257169 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An individual peer support program delivered to young people from 3 months prior to, until 3 months post discharge from a specialist first episode psychosis center. People will receive 2 hours of contact per fortnight from the peer support worker which will include an in-reach and out-reach service and will include supportive informal contact, assistance making health related appointments, assistance with public transport to appointments and support in accessing new services. Participants will receive the peer support intervention plus standard care.
Intervention code [1] 256185 0
Rehabilitation
Comparator / control treatment
Standard care as determined by the case manager
Control group
Active

Outcomes
Primary outcome [1] 258052 0
Increased engagement and treatment adherence, as measured by The Psychosocial Treatment Compliance Scale (Tsang, et al., 2006), by specific questions included in a treatment questionnaire and via a telephone call made by the Research Assistant (RA) to the new treating clinician asking about attendance at appointments and medication compliance
Timepoint [1] 258052 0
Baseline
6 months (post intervention)
Primary outcome [2] 258053 0
Increased perceived social support and increased quantity and improved quality of information provided, as measured by the Multi-dimensional Scale of Perceived Social Support (Zimet et al., 1988).
Timepoint [2] 258053 0
Baseline
6 months (post intervention)
Primary outcome [3] 258054 0
Increased service satisfaction, as measured by the Verona Service Satisfaction Scale.
Timepoint [3] 258054 0
Baseline
6 months (post intervention)
Secondary outcome [1] 263633 0
Reduced risk of suicide, as measured by The Reynolds Suicidal Ideation Questionnaire (Reynolds, 1988).
Timepoint [1] 263633 0
Baseline
6 months (post intervention)
Secondary outcome [2] 263639 0
Increased quality of life as measured by the World Health Organisation Quality of Life Scale (Heinrichs et al., 1984).
Timepoint [2] 263639 0
Baseline
6 months (post intervention)

Eligibility
Key inclusion criteria
Aged 15-24 and being discharged from a specialist first-episode psychosis center; the Early Psychosis Prevention and Intervention Center (EPPIC) having been treated for first-episode psychosis
Minimum age
15 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A recent history of violence against the person
An inability to provide informed consent
Inability to speak English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study team comprises researchers and representatives from the clinical program. The research assistant (RA) will attend the regular clinical meetings held at EPPIC in order to identify young people who are about to commence the discharge planning period. Once the discharge planning process is about to begin the RA will contact the young person and see if they are interested in the study. If so they will obtain written consent and conduct the baseline assessment. Once the baseline assessment is conducted the young person’s details will be passed to an independent statistician who will randomise them into either the treatment or control group. Those in the control group will receive treatment as usual (TAU) whilst those in the treatment group will receive treatment as usual plus the peer support intervention (TAU+PSI).

Once randomisation has taken place the statistician will contact either the project supervisor or the Peer Support Coordinator directly that the intervention can begin. The Peer Support Coordinator will allocate a peer support worker (PSW) who will make contact with the participant and will deliver the intervention. By doing this in this way the RA can remain blind to treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation procedure will follow the consort guidelines. The subjects will be randomized to the treatment group or control group with equal allocation. Computer generated random numbers will be used to carry out the randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256687 0
Charities/Societies/Foundations
Name [1] 256687 0
Orygen Youth Health Research Centre
Country [1] 256687 0
Australia
Funding source category [2] 256688 0
Charities/Societies/Foundations
Name [2] 256688 0
Myer Foundation
Country [2] 256688 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen Youth Health Research Centre
Address
35 Poplar Road
Parkville
Vic, 3052
Country
Australia
Secondary sponsor category [1] 255976 0
None
Name [1] 255976 0
Address [1] 255976 0
Country [1] 255976 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258708 0
Mental Health Research and Ethics Committee
Ethics committee address [1] 258708 0
Ethics committee country [1] 258708 0
Australia
Date submitted for ethics approval [1] 258708 0
29/01/2010
Approval date [1] 258708 0
Ethics approval number [1] 258708 0
2010.050

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

Contacts
Principal investigator
Name 30968 0
Address 30968 0
Country 30968 0
Phone 30968 0
Fax 30968 0
Email 30968 0
Contact person for public queries
Name 14215 0
Jo Robinson
Address 14215 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville, Vic, 3052
Country 14215 0
Australia
Phone 14215 0
+61 3 9342 2866
Fax 14215 0
+61 3 9342 2941
Email 14215 0
[email protected]
Contact person for scientific queries
Name 5143 0
Jo Robinson
Address 5143 0
Orygen Youth Health Research Centre
35 Poplar Road
Parkville,
Vic, 3052
Country 5143 0
Australia
Phone 5143 0
+61 3 9342 2866
Fax 5143 0
+61 3 9342 2941
Email 5143 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.