Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000925943
Ethics application status
Approved
Date submitted
29/08/2011
Date registered
29/08/2011
Date last updated
10/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of self-exclusion educational DVD for problem gamblers
Scientific title
The effectiveness of a five-minute educational DVD in improving treatment up-take rates for self-excluding problem gamblers
Secondary ID [1] 262945 0
Nil
Universal Trial Number (UTN)
U1111 1123 8427
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problem gambling 270670 0
Condition category
Condition code
Mental Health 270844 270844 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a five-minute educational DVD designed to inform problem gamblers requesting self-exclusion of the nature and responsibilities of the self-exclusion order, and to enhance motivation (reflected in increased take-up rates) to seek treatment interventions.
Intervention code [1] 269288 0
Treatment: Other
Comparator / control treatment
Self-excluding problem gamblers completing current standard self-exclusion procedures. The standard procedure is for a problem gamblers seeking to self exclude to approach the responsible gambling manager, be informed of the conditions and requirements of self-exclusion, complete a self-exclusion order, and then he/she is refused entry into the casino if subsequently detected attempting to enter.
Control group
Active

Outcomes
Primary outcome [1] 279525 0
Primary outcome: Increased take-up rates of treatment interventions for problem gambling achieved through clinical interview eliciting self-reported data describing the types of treatments received from point of self-exclusion to follow-up, and all treatments received prior to self-exclusion.
Timepoint [1] 279525 0
Baseline and six months follow-up
Secondary outcome [1] 287835 0
Improved understanding of self-exclusion order requirements determined by responses to an investigator constructed semi-structured clinical interview using categorical and visual analogue rating scales to record responses
Timepoint [1] 287835 0
Baseline and six months follow-up
Secondary outcome [2] 287836 0
Indices of gambling behaviour (frequency (sessions per week), expenditure (average size per bet)) and number of self-exclusion breaches using self-reported data elicited by an investigator constructed semi-structured interview.
Timepoint [2] 287836 0
Baseline and six months follow-up
Secondary outcome [3] 287837 0
Changes in Quality of Life Inventory scores
Timepoint [3] 287837 0
Baseline and six months follow-up
Secondary outcome [4] 287845 0
Visual analogue scales will be used to assess self-efficacy and perception of control over gambling urges and behaviour on a ten-point rating scale with anchor points - not at all to very much
Timepoint [4] 287845 0
Baseline and six months follow-up

Eligibility
Key inclusion criteria
Problem gamblers seeking to enter a voluntary self-exclusion program offered by specific participating Casinos in Canadian Provinces
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Actively psychotic; suicidal

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)
Randomly generated numbers will be placed in sealed opaque envelopes and given to Casino self-exclusion officer to allocate participant to one of two conditions on eligibility to participate.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software random number generator.
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

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/10/2011
Actual
3/02/2012
Date of last participant enrolment
Anticipated
31/12/2015
Actual
29/12/2016
Date of last data collection
Anticipated
2/01/2017
Actual
Sample size
Target
300
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 3820 0
Canada
State/province [1] 3820 0
Ontario

Funding & Sponsors
Funding source category [1] 269749 0
Other
Name [1] 269749 0
Ontario Problem Gambling Research Centre
Country [1] 269749 0
Canada
Primary sponsor type
Individual
Name
Scott Maitland
Address
225 Macdonald Institute
Family Relations & Applied Nutrition
University of Guelph,
Guelph, ON N1G 2W1
Country
Canada
Secondary sponsor category [1] 268789 0
Individual
Name [1] 268789 0
Alexander Blaszczynski
Address [1] 268789 0
School of Psychology (A18)
The University of Sydney
Sydney NSW 2006
Country [1] 268789 0
Australia
Other collaborator category [1] 252231 0
Individual
Name [1] 252231 0
Robert Ladouceur
Address [1] 252231 0
University Laval
2325, rue des Bibliotheques
Bureau 1328
Quebec (Quebec), G1V 0A6.
Country [1] 252231 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271714 0
University of Guelph REB
Ethics committee address [1] 271714 0
50 Stone Rd E, Guelph, ON N1G 2W1, Canada
Ethics committee country [1] 271714 0
Canada
Date submitted for ethics approval [1] 271714 0
Approval date [1] 271714 0
11/08/2011
Ethics approval number [1] 271714 0
11MY042

Summary
Brief summary
The purpose of the study is to investigate the effectiveness of a 5-minute intervention DVD on (1) increased compliance with self-exclusion orders, (2) increased uptake of concurrent mental health treatments, self-help resources and groups, and counseling, and (3) reduction in gambling related-harms and severity of problem gambling. The design will include a randomized controlled trial (an intervention group (DVD) and a control group receiving current standard procedures) in which the DVD will be provided to a sample of self-excluders and outcomes compared to a sample receiving ‘treatment as usual’ that is, the standard self-exclusion information package and procedure.

Specific hypotheses:
1. That a 5-minute intervention DVD informing self-excluders of the nature and requirements of the program and utilizing motivational interviewing principles guiding self-evaluation and appraisal coupled with benefits of accessing complementary treatment interventions will:
a. Increase the proportion of self-excluders taking up referrals to appropriate mental health treatment interventions
b. Increase compliance with self-exclusion requirements as assessed by reduced number of detected and self-reported breaches
c. Reduced severity of gambling behaviour and harms as assessed by scores on the PGSI of the CPGI, DSM-IV, patterns of self-reported behaviour and expenditure, improved relationships and psychological well being, and measures of gambling-related harms, in addition to event history (timing of breaches relative to initiating self-exclusion).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33086 0
Prof Scott Maitland
Address 33086 0
Family Relations & Human Development
University of Guelph
Guelph ON N1G 2W1
Country 33086 0
Canada
Phone 33086 0
+1 519 824-4120 x56156
Fax 33086 0
Email 33086 0
[email protected]
Contact person for public queries
Name 16333 0
Prof Alexander Blaszczynski
Address 16333 0
School of Psychology (A18)
The University of Sydney
Sydney, NSW 2006
Country 16333 0
Australia
Phone 16333 0
+61 2 90367227
Fax 16333 0
+61 2 9351 7328
Email 16333 0
[email protected]
Contact person for scientific queries
Name 7261 0
Prof Alexander Blaszczynski
Address 7261 0
School of Psychology (A18)
The University of Sydney
Sydney, NSW 2006
Country 7261 0
Australia
Phone 7261 0
+61 2 9036 7227
Fax 7261 0
+ 61 2 9351 7328
Email 7261 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
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