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Trial registered on ANZCTR


Registration number
ACTRN12620001236987
Ethics application status
Approved
Date submitted
7/09/2020
Date registered
18/11/2020
Date last updated
18/11/2020
Date data sharing statement initially provided
18/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Peer support for Asian international students with experience of harmful gambling
Scientific title
Investigating the effectiveness of peer support on gambling relapse: A group programme for Chinese and South Asian international students with experience of harmful gambling

Secondary ID [1] 300761 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
problem gambling 316610 0
Condition category
Condition code
Mental Health 314842 314842 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Relapse prevention intervention
Eight weekly 1½ hour sessions of group programme which incorporates content related to self-understanding, peer support and relapse prevention strategies. (1) Group formation: participants share expectations and begin self-discovery journey; (2) Explore cultural beliefs and common concerns in life in the context of challenges for international students; (3) Gain knowledge about features of harmful gambling and learn how to set healthy boundaries to stay away from gambling; (4) Start to develop a wellness plan: explore strategies for stress management, learn mindfulness and affirm personal strengths through peer support; (5) Further develop the wellness plan encompassing wider social and environmental factors (e.g. friends, families and communities who they can rely on to provide support); (6) Identify the triggers of relapse of harmful gambling and incorporate strategies for managing gambling urges and cravings into the wellness plan; (7) Learn healthy alternative activities to engage in to enhance wellbeing and where to seek support in New Zealand; (8) Evaluation, future hopes and dreams. Activities to be completed in the group intervention sessions will include educational sessions, individual exercises, team-work and open discussion of topics. A maximum of 8 participants will be included in a group intervention session. Each participant will be provided with a booklet to keep their attendance and changes made over the duration of the intervention. The intervention will be delivered by qualified counsellors and social workers (registered with either the New Zealand Association of Counsellors, Social Worker Registration Board New Zealand or the Drug and Alcohol Practitioners' Association Aotearoa New Zealand) who can speak English, Mandarin and Cantonese (for the group with Chinese international students) or English and Hindi (for the group with South Asian international students) and with minimum 5 years’ experience in the areas of gambling addiction and mental health. Group sessions will be held in a room at Asian Family Services premises where privacy can be maximised.
Intervention code [1] 318532 0
Behaviour
Intervention code [2] 318533 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325035 0
% with Problem Gambling Severity Index (PGSI) score < 5
Timepoint [1] 325035 0
At the first session and then the 8th session (8 weeks after intervention commencement)
Primary outcome [2] 325036 0
% with General Help-seeking Questionnaire score > 80
Timepoint [2] 325036 0
At the first session and the 8th session (8 weeks after intervention commencement)
Secondary outcome [1] 386611 0
% with Attitudes towards Harmful Gambling score (questionnaire designed for the study) > 5
Timepoint [1] 386611 0
At the first session and then the 3rd session (3 weeks after intervention commencement)
Secondary outcome [2] 386612 0
% with Stress Management score (questionnaire designed for the study) > 5
Timepoint [2] 386612 0
At the first session and then the 4th session (4 weeks after intervention commencement)
Secondary outcome [3] 386613 0
% with Knowledge about the Triggers of Relapse of Harmful Gambling score (questionnaire designed for the study) > 5
Timepoint [3] 386613 0
At recruitment, and then the 6th session (6 weeks after intervention commencement)

Eligibility
Key inclusion criteria
International students studying at tertiary education institutions in the Auckland region, aged 18 years or over, self-identify as Chinese or South Asian (e.g. Indian, Pakistani, Sri Lankan, or any other South Asian sub-groups), have experience of gambling-related problems and are interested in reducing or stopping the gambling behaviour causing harm
Minimum age
18 Years
Maximum age
34 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-Chinese, non-South Asian international students; aged under 18 years; not studying at a university, polytechnic or language school; not living in the Auckland region; have not gambled in the past 12 months and a PGSI score of 2 or below.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
This is a pilot study to investigate the effectiveness of a relapse prevention group programme among two groups of international students (Chinese and South Asian). Maximum number in each group is 10, because intervention’s effectiveness can decrease if group size is more than 10. Analysis of pre-post changes in: (1) harmful gambling behaviour will be measured by PGSI scores, from score 8+ (problem gamblers) to score 3-7 (moderate risk gamblers) or score 0-2 (non-gamblers or low-risk gamblers); (2) help-seeking behaviour will be measured by the General Help-seeking questionnaire, with scores from 20 (extremely unlikely to seek help) to 140 (extremely likely to seek help) . Secondary outcomes will include: changes in attitudes towards harmful gambling, knowledge of the triggers of relapse of harmful gambling and skills in stress management; each will be measured by a scale of 1 to 10, from score 1-3 (poor attitudes/knowledge/skills) to 4-7 (moderate attitudes/knowledge/skills) or 8-10 (excellent attitudes/knowledge/skills). Data will also be compared and analysed across the two groups of international students to identify factors contributing to reducing the risk of relapsing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2021
Actual
Date of last participant enrolment
Anticipated
5/03/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 22922 0
New Zealand
State/province [1] 22922 0
Auckland

Funding & Sponsors
Funding source category [1] 305222 0
Government body
Name [1] 305222 0
Ministry of Health
Country [1] 305222 0
New Zealand
Primary sponsor type
Individual
Name
Dr Elsie Ho
Address
Asian Family Services, Level 1, 128 Khyber Pass Road, Grafton, Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 307217 0
None
Name [1] 307217 0
Address [1] 307217 0
Country [1] 307217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305569 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 305569 0
Ethics committee country [1] 305569 0
New Zealand
Date submitted for ethics approval [1] 305569 0
11/12/2019
Approval date [1] 305569 0
20/12/2019
Ethics approval number [1] 305569 0
19/CEN/223

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

Contacts
Principal investigator
Name 100806 0
Dr Elsie Ho
Address 100806 0
Asian Family Services, Level 1, 128 Khyber Pass Road, Grafton, Auckland 1023, New Zealand


Country 100806 0
New Zealand
Phone 100806 0
+64 8 0086 2343
Fax 100806 0
Email 100806 0
[email protected]
Contact person for public queries
Name 100807 0
Elsie Ho
Address 100807 0
Asian Family Services, Level 1, 128 Khyber Pass Road, Grafton, Auckland 1023, New Zealand


Country 100807 0
New Zealand
Phone 100807 0
+64 8 0086 2343
Fax 100807 0
Email 100807 0
[email protected]
Contact person for scientific queries
Name 100808 0
Elsie Ho
Address 100808 0
Asian Family Services, Level 1, 128 Khyber Pass Road, Grafton, Auckland 1023, New Zealand


Country 100808 0
New Zealand
Phone 100808 0
+64 8 0086 2343
Fax 100808 0
Email 100808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This pilot study will only involve a small number of participants (20). Individual participant data will not be shared to protect client confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9075Study protocol    379437-(Uploaded-07-09-2020-09-08-35)-Study-related document.pdf
9076Informed consent form    379437-(Uploaded-07-09-2020-09-09-33)-Study-related document.pdf
9077Ethical approval    379437-(Uploaded-07-09-2020-09-10-12)-Study-related document.pdf



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.