Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000885493
Ethics application status
Approved
Date submitted
3/03/2016
Date registered
6/07/2016
Date last updated
6/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Sidekicks: Evaluation of a training program aimed at strengthening personal and interpersonal skills
Scientific title
Sidekicks: Evaluation of a training program aimed at strengthening personal and interpersonal skills in university students
Secondary ID [1] 288685 0
None
Universal Trial Number (UTN)
U1111-1180-3803
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy participants - community response to mental distress 297895 0
Condition category
Condition code
Mental Health 298060 298060 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 one hour (once per week) session training program targeting helping skills in response to friends/family in mental distress.
Education in responding to low emotion, high anxiety, high stress.
Education in responding to someone reporting suicidal thoughts.
Education in responding to people who do not wish to seek help.
Practice of empathic listening skills.
The intervention will delivered by two clinical psychologists in a face to face group ranging from 20-50 students in each group.
Monitoring of adherence is carried out by register of participant attendance at each session
Intervention code [1] 294109 0
Behaviour
Comparator / control treatment
Pre-Post Intervention; each member of the sample acts as their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297582 0
SIRI-II The Suicide Intervention Response Inventory - this measures skills in responding to suicidal behaviour
Timepoint [1] 297582 0
Baseline and Post Workshop (5 weeks)
Primary outcome [2] 298420 0
Ryff scale of psychological well being (PR sub scale)
Timepoint [2] 298420 0
Baseline and Post Workshop (5 weeks)
Primary outcome [3] 298421 0
Stigma belief (SSOSH scale, SSRPH scale)
Timepoint [3] 298421 0
Baseline and Post Workshop (5 weeks)
Secondary outcome [1] 321464 0
psychological flexibility (AAQ-II)
Timepoint [1] 321464 0
Baseline and Post Workshop (5 weeks)
Secondary outcome [2] 324076 0
empathy (EQ-8)
Timepoint [2] 324076 0
Baseline and Post Workshop (5 weeks)

Eligibility
Key inclusion criteria
Students of the University of Sydney
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who the study investigators assess as having their mental well being compromised by participation in the workshop

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired T-Test/ANOVA
Mediation analysis

A prior pilot study (Sheehan, Stanton and Renner, 2016) examined results in the area of stigma change (SSOSH, SSRPH questionnaires) and self-reported confidence in helping others (on a likert scale) at pre and post intervention.

An analysis of statistical power was carried out using the differences in means and differences in standard deviations from that study. For the outcome variable of confidence in helping others a sample size of 15 is required (P=.05; power 80%) based on a prior effect size of Cohen's D=1.13. For the outcome variables of change in beliefs related to stigma, a sample size of 98 is required for the SSOSH measure (Cohen's D=0.28) and a sample size of 96 is required for the SSOSH measure (P=.05; power 80%; Cohen's D=0.29).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/07/2016
Actual
Date of last participant enrolment
Anticipated
1/05/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
98
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293043 0
University
Name [1] 293043 0
University of Sydney
Country [1] 293043 0
Australia
Primary sponsor type
Individual
Name
Dr Philomena Renner
Address
Jane Foss Russell Building, Level 5
University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 291821 0
None
Name [1] 291821 0
N/A
Address [1] 291821 0
N/A
Country [1] 291821 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294552 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 294552 0
Ethics committee country [1] 294552 0
Australia
Date submitted for ethics approval [1] 294552 0
11/02/2016
Approval date [1] 294552 0
11/03/2016
Ethics approval number [1] 294552 0
2016/138

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

Contacts
Principal investigator
Name 64118 0
Mr Patrick Sheehan
Address 64118 0
Counselling and Psychological Services
Room 513, Level 5
Jane Foss Russell Building
The University of Sydney NSW 2006
Country 64118 0
Australia
Phone 64118 0
+61286278433
Fax 64118 0
Email 64118 0
[email protected]
Contact person for public queries
Name 64119 0
Patrick Sheehan
Address 64119 0
Counselling and Psychological Services
Room 513, Level 5
Jane Foss Russell Building
The University of Sydney NSW 2006
Country 64119 0
Australia
Phone 64119 0
+61286278433
Fax 64119 0
Email 64119 0
[email protected]
Contact person for scientific queries
Name 64120 0
Patrick Sheehan
Address 64120 0
Counselling and Psychological Services
Room 513, Level 5
Jane Foss Russell Building
The University of Sydney NSW 2006
Country 64120 0
Australia
Phone 64120 0
+61286278433
Fax 64120 0
Email 64120 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.