Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000970448
Ethics application status
Approved
Date submitted
28/05/2025
Date registered
3/09/2025
Date last updated
3/09/2025
Date data sharing statement initially provided
3/09/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Support for families to motivate treatment-refusing heavy gamblers to reduce their gambling and seek help: A pilot study
Scientific title
The family reinforcement and contingency management approach for friends and families of heavy gamblers: A feasibility single-blinded parallel two-arm pragmatic randomised control trial
Secondary ID [1] 308822 0
None
Universal Trial Number (UTN)
U1111-1287-4703
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gambling addiction 328779 0
Condition category
Condition code
Mental Health 325787 325787 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants received a brief structured intervention of up to six individual 60-minute sessions informed by Barber et al.’s (1995) intervention for heavy drinkers and adapted for use with gamblers. FRCM-Gam is based on learning theory principles and teaches CSOs to respond to the problem behaviour in a way that both empowers the CSOs and provides incentives for the gambler to change by decreasing the advantages of engaging in the problem behaviour and increasing the advantages of behaving differently. The intervention involves five graded steps of responses designed to gradually increase motivation for the gambler to change. Step one involves preparing the CSO by providing information about gambling addiction and CBT, the FRCM-Gam approach and collecting information about the gambler’s gambling behaviour. Step two involves identifying the benefits the gambler gains from gambling and identifying incompatible and desired behaviours (contingency management) and the principles of operant conditioning and shaping taught. At step three CSOs are taught to use the principles of operant conditioning and shaping to respond to the gambler when they display signs of gambling, non-gambling, or desirable behaviours. At step four CSOs make an agreement with the gambler about when they will engage in incompatible or desirable behaviours. Step five looks for ways to involve others in the behavioural plan if previous steps have not been successful. The experimental intervention will be delivered by up to six individual 60-minute sessions over six to eight weeks via in-person or telehealth videocall. The intervention will be delivered by a mental health clinician with a master's degree in CBT (psychologist, social worker, or psychiatric nurse),
Intervention code [1] 331178 0
Behaviour
Comparator / control treatment
Standard care
Participants received a brief structured intervention of up to six individual 60-minute sessions covering three areas. The first component provided information about gambling addiction from a cognitive behavioural perspective. The second component involved information and strategies about how CSOs can protect themselves financially from gambling-related harm. The third component involved stress management using principles of behavioural activation. The standard care intervention will be delivered by up to six individual 60-minute sessions over six to eight weeks via in-person or telehealth videocall. The intervention will be delivered by a mental health clinician with a master's degree in CBT (psychologist, social worker, or psychiatric nurse),
Control group
Active

Outcomes
Primary outcome [1] 341646 0
Feasibility related: 1) Proportion recruited, defined as the number who consented to enter the study over the number who were screened for the study. Recruitment and number screened will be determined from study logs.
Timepoint [1] 341646 0
When recruitment target of N=30 is met
Primary outcome [2] 342216 0
Feasibility related 2) Proportion of drop out/research attrition, defined as the number who left the study before attending a therapy session, over those who were randomised to a treatment arm. Dropout rates will be determined from clinic records.
Timepoint [2] 342216 0
End of study when final participant has reached 1-month follow up
Primary outcome [3] 342294 0
Feasibility related 3) Completeness of outcome data, defined as the proportion of data that was complete at the 1-month follow-up outcome. The completeness of outcome data will be determined through an audit of completed questionnaires.
Timepoint [3] 342294 0
End of study when final participant has reached 1-month follow up
Secondary outcome [1] 449409 0
In addition, to the primary clinical outcome, the following outcomes concerning the wellbeing of concerned significant others (CSO)s will be collected: Patient Health Questionnaire (PHQ-9;(Kroenke et al., 2001) is a measure of depression. The scale consists of nice items that correspond to Diagnostic and Statistical Manual of Mental Disorders (4th ed.;DSM-IV) Diagnostic Criterion A symptoms for major depressive disorder (American Psychiatric & American Psychiatric Association. Task Force on, 1994). Cronbach’s alpha coefficients have been reported as .86 to .89 (Kroenke et al., 2001).
Timepoint [1] 449409 0
T1 Baseline, T2 immediately following completion of up to 6 sessions. Sessions may be delivered weekly over 6 weeks or spread over up to 8 weeks. T3 is 12 weeks from baseline.
Secondary outcome [2] 450002 0
Kessler Psychological Distress Scale (K10(Kessler et al., 2002) is a 10-item self-report scale developed to measure non-specific psychological distress. The K10 has high internal consistency and a Cronbach’s alpha of 0.84 (Kessler et al., 2002).
Timepoint [2] 450002 0
T1 Baseline, T2 immediately following completion of up to 6 sessions. Sessions may be delivered weekly over 6 weeks or spread over up to 8 weeks. T3 is 12 weeks from baseline.
Secondary outcome [3] 450003 0
Work and Social Adjustment Scale (WSAS; (Mundt et al., 2002)is a five-item self-report scale of social and work-related functional impairment attributable to an identified problem. It has strong psychometrical properties with reported Cronbach’s alpha of 0.70 to 0.94 (Mundt et al., 2002).
Timepoint [3] 450003 0
T1 Baseline, T2 immediately following completion of up to 6 sessions. Sessions may be delivered weekly over 6 weeks or spread over up to 8 weeks. T3 is 12 weeks from baseline.
Secondary outcome [4] 450004 0
Brief Family Relationship Scale (BFRS; (Fok et al., 2014) is a 19 item three factor self-report scale that measures a persons’ perception of his or her family functioning and has sound psychometric properties with reported Chonbach’s apha of 0.83 for the total scale with subscales also demonstrated acceptable reliability (range: 0.7-0.80) (Fok et al., 2014).
Timepoint [4] 450004 0
T1 Baseline, T2 immediately following completion of up to 6 sessions. Sessions may be delivered weekly over 6 weeks or spread over up to 8 weeks. T3 is 12 weeks from baseline.
Secondary outcome [5] 450005 0
Proportion of gamblers who are referred for treatment, as defined by the gambler accepting referral for treatment and an appointment being offered as determined from clinic records.
Timepoint [5] 450005 0
At the 1-month follow up period
Secondary outcome [6] 450006 0
Qualitative semi-structured interviews with up to 10 participants who received the experimental intervention. The semi-structured interview protocol is as follows: Qualitative interview questions for FRCM-Gam study 1. Can you describe your overall experience with the program? 2. What aspects of the program did you find particularly helpful? 3. Can you describe any positive changes you experienced as a result of this program? 4. Did you have any concerns about applying any of the strategies taught in this program? 5. How easy or difficult was it to understand the principles and strategies taught in this program? 6. What, if anything, do you think could be done differently to make the program more effective or beneficial? 7. How relevant do you think this program is for family or friends who are concerned about a loved one’s heavy gambling? 8. Is there anything else you would like to add? We will use purposive sampling to intentionally recruit participants who were successful in motivating the gambler to enter treatment, and those who were not able to motivate the gambler to enter treatment. We will use maximum variation sampling to recruit a diverse range of relationships of the participant to the gambler to ensure we capture the voices of partners, parents, siblings, friends.
Timepoint [6] 450006 0
End of study after the 1-month follow up period
Secondary outcome [7] 451731 0
Proportion of gamblers who enter treatment as defined by attending at least one therapy appointment as determined by clinic records.
Timepoint [7] 451731 0
At the 1-month follow-up point.

Eligibility
Key inclusion criteria
Study eligibility is based on the following inclusion criteria: (1) individuals 18 years of age or older, (2) living with a family member or friend who they believe has a gambling problem and was not currently seeking help. If not living with the gambler, participants are required to have regular contact with them (at least once a week). The individual with the gambling problem is not required to have been formally diagnosed with a gambling disorder; it is sufficient that the participant report presence of a gambling problem. Family members have been found to be able to report problem gambling behaviour in a reliable and valid manner (Hodgins & Makarchuk, 2003).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded if: (1) risk of violence is identified, (2) the potential participant also has a gambling problem, (3) experiencing significant mental distress e.g., psychosis or suicidality so as not to be able to provide informed consent, (4) not proficient in speaking and reading English. (5) not having regular contact (at least once a week) with the gambler. An initial screening interview will be conducted by telephone. On passing the online and telephone screening, participants will be provided with an information and consent form. On receipt of their consent form, they will be randomised to the intervention or standard care.


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 allocation will be performed by an administrative staff member who was not involved with the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be blocked to increase the likelihood of equal group sizes, using a standard permutated block algorithm in which block sizes will be randomly chosen from 2, 4, and 6 to protect concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
17/10/2023
Date of last participant enrolment
Anticipated
Actual
25/03/2025
Date of last data collection
Anticipated
Actual
28/06/2025
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 313045 0
Government body
Name [1] 313045 0
Southern Adelaide Local Health Network
Country [1] 313045 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 321850 0
Government body
Name [1] 321850 0
Flinders Psychological Therapy Service Statewide Gambling Therapy Service
Address [1] 321850 0
Country [1] 321850 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312298 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 312298 0
Ethics committee country [1] 312298 0
Australia
Date submitted for ethics approval [1] 312298 0
12/05/2023
Approval date [1] 312298 0
26/07/2023
Ethics approval number [1] 312298 0

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

Contacts
Principal investigator
Name 124158 0
Dr Ben Riley
Address 124158 0
Flinders Psychological Therapy Service, The Flats, Flinders Drive Bedford Park, SA, 5063
Country 124158 0
Australia
Phone 124158 0
+61 0412181010
Fax 124158 0
Email 124158 0
[email protected]
Contact person for public queries
Name 124159 0
Ben Riley
Address 124159 0
Flinders Psychological Therapy Service, The Flats, Flinders Drive Bedford Park, SA, 5063
Country 124159 0
Australia
Phone 124159 0
+61 0882044779
Fax 124159 0
Email 124159 0
[email protected]
Contact person for scientific queries
Name 124160 0
Ben Riley
Address 124160 0
Flinders Psychological Therapy Service, The Flats, Flinders Drive Bedford Park, SA, 5063
Country 124160 0
Australia
Phone 124160 0
+61 0882044779
Fax 124160 0
Email 124160 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.