Problem GamblingNCT06642155
Theory-based Intervention for Promoting Responsible Gambling Among College Students
A study testing RESPONSIBLEPLAY© MTM-Based Intervention and Knowledge-Based Intervention in people with Problem Gambling and Pathological Gambling, run by University of Nevada, Las Vegas.
Trial summary
The goal of this clinical trial is to learn if the RESPONSIBLEPLAY© intervention helps promote responsible gambling behaviors in University of Nevada, Las Vegas (UNLV) students aged 21 and older who have a Problem Gambling Severity Index (PGSI) score of 3 or higher. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problem Gambling, Pathological Gambling, Behavioral Addiction
- What is being tested?
- RESPONSIBLEPLAY© MTM-Based Intervention and Knowledge-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 21 years old.
- Must be a enrolled UNLV student.
- Must engage in gambling activities.
- Must have a score of 3 or higher on the Problem Gambling Severity Index (PGSI), indicating at-risk or problem gambling behavior.
Who cannot join
- Participants currently receiving treatment for gambling disorders.
- Individuals with cognitive impairments that would affect their ability to provide consent or participate in the intervention.
- Individuals who are not fluent in English (since the intervention materials and assessments will be conducted in English).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Testing the Efficacy of ResponsiblePlay©: MTM-Based Intervention for Responsible Gambling for College Students
The goal of this clinical trial is to learn if the RESPONSIBLEPLAY© intervention helps promote responsible gambling behaviors in University of Nevada, Las Vegas (UNLV) students aged 21 and older who have a Problem Gambling Severity Index (PGSI) score of 3 or higher. The main questions it aims to answer are:
Does the intervention reduce harmful gambling behaviors? Does the intervention increase responsible gambling practices? Researchers will compare participants receiving the RESPONSIBLEPLAY© intervention with those receiving a knowledge-based intervention to see if the RESPONSIBLEPLAY© intervention is more effective.
Read more
Participants will:
Attend three face-to-face sessions on responsible gambling over three weeks. Complete surveys before, after, and eight weeks after the intervention to track their progress.
Read the detailed description
This study investigates the efficacy of the RESPONSIBLEPLAY© intervention, designed to promote responsible gambling behaviors among college students at UNLV. College students are a vulnerable group for developing gambling-related problems, with a significantly higher prevalence of problem and pathological gambling compared to the general population. This randomized controlled trial (RCT) will compare the RESPONSIBLEPLAY© intervention, which is based on the Multi-theory Model (MTM) of health behavior change, to a traditional knowledge-based intervention.
The RESPONSIBLEPLAY© intervention addresses both the initiation and sustenance of behavior change, incorporating elements such as participatory dialogue, behavioral confidence, and changes in the social and physical environments. The intervention aims to equip participants with practical strategies to manage and limit gambling behaviors.
The study will take place over a three-week period, with face-to-face sessions designed to engage participants in discussions and self-guided activities that promote responsible gambling. Follow-up assessments will be conducted at eight weeks post-intervention to evaluate the long-term impact of the intervention. A two-factor repeated measures analysis will be used to assess changes in gambling behaviors and related psychological constructs over time.
The findings from this study may provide critical evidence to support the use of theory-based interventions to reduce gambling-related harms in a college student population, which can inform future public health strategies.
- Being tested
- RESPONSIBLEPLAY© MTM-Based Intervention, Knowledge-Based Intervention
- Keywords
- Responsible Gambling, College Students, Problem Gambling, Pathological Gambling, Behavioral Interventions, Health Behavior Change, Multi-theory Model (MTM), Randomized Controlled Trial (RCT), Public Health Intervention, Gambling Disorder Prevention
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPONSIBLEPLAY© MTM-Based InterventionBehavioural
Participants in this group will receive a theory-based intervention using the Multi-theory Model (MTM) of health behavior change. The intervention includes participatory dialogue, behavioral confidence-building, and strategies to modify the physical and social environments. It also incorporates emotional transformation and practice for change. Sessions will be delivered in-person over three weeks, focusing on promoting responsible gambling behaviors.
Knowledge-Based InterventionBehavioural
Participants in this group will receive a knowledge-based intervention that provides information on gambling risks and responsible gambling strategies. The intervention consists of lectures and reading materials delivered in-person over three weeks. It focuses on raising awareness of gambling risks but does not include the behavioral change strategies used in the MTM-based intervention.
| Study group | Role | What they receive |
|---|---|---|
| RESPONSIBLEPLAY© MTM-Based Intervention | Experimental | Participants will receive a theory-based intervention designed to promote responsible gambling behaviors using the Multi-theory Model (MTM) of health behavior change. The intervention focuses on both the initiation and sustenance of responsible gambling through six constructs:
Participatory Dialogue: Discussing the pros and cons of responsible gambling. Behavioral Confidence: Building confidence to practice responsible gambling. Changes in the Physical Environment: Modifying surroundings to limit gambling opportunities.
Emotional Transformation: Managing emotions to maintain behavior change. Practice for Change: Planning and practicing responsible gambling strategies. Changes in the Social Environment: Leveraging support from family, friends, and professionals.
This intervention aims to provide practical strategies for adopting and maintaining responsible gambling behaviors. Receives: Behavioral: RESPONSIBLEPLAY© MTM-Based Intervention |
| Knowledge-Based Intervention | Active comparator | Participants will receive educational content about the risks of gambling and strategies for responsible gambling in the form of lectures and reading materials. Receives: Behavioral: Knowledge-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Problem Gambling Severity Index (PGSI) Score
The primary outcome will assess changes in the Problem Gambling Severity Index (PGSI) scores, which measure the severity of gambling behavior. The PGSI includes 9 items with a score range of 0 to 27, where higher scores indicate more severe gambling issues. Scores will be collected at baseline, immediately post-intervention, and at an eight-week follow-up.
Measured: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Secondary outcomes (8)
Change in Participatory Dialogue (Perceived Advantages Minus Perceived Disadvantages) for Responsible Gambling
This outcome will measure changes in the Participatory Dialogue construct by assessing both perceived advantages and perceived disadvantages of responsible gambling.
Perceived Advantages will be measured using 5 items (questions 12-16) scored from 0 (not at all likely) to 4 (completely likely), with a possible score range of 0 to 20.
Perceived Disadvantages will be measured using 5 items (questions 17-21) scored from 0 (not at all likely) to 4 (completely likely), with a possible score range of 0 to 20.
The overall Participatory Dialogue score is calculated by subtracting the perceived disadvantages score from the perceived advantages score, yielding a possible range from -20 to +20.
Measured: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Behavioral Confidence for Responsible Gambling
This outcome will measure changes in Behavioral Confidence using 4 items (questions 22-25) that assess participants' confidence in engaging in responsible gambling. Items are scored on a 5-point Likert scale from 0 (not at all confident) to 4 (completely confident), with a possible total score ranging from 0 to 16 units.
Measured: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in the Physical Environment for Responsible Gambling
This outcome will measure changes in Changes in the Physical Environment using 3 items (questions 26-28) that assess participants' ability to avoid gambling environments and resist access to gambling resources. Items are scored on a 5-point Likert scale from 0 (not at all sure) to 4 (completely sure), with a possible total score ranging from 0 to 12 units.
Measured: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Emotional Transformation for Responsible Gambling
This outcome will measure changes in Emotional Transformation using 3 items (questions 29-31) that assess participants' ability to manage their emotions and stay motivated toward responsible gambling. Items are scored on a 5-point Likert scale from 0 (not at all sure) to 4 (completely sure), with a possible total score ranging from 0 to 12 units.
Measured: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Practice for Change for Responsible Gambling
This outcome will measure changes in Practice for Change using 3 items (questions 32-34) that assess participants' ability to maintain responsible gambling behaviors. Items are scored on a 5-point Likert scale from 0 (not at all sure) to 4 (completely sure), with a possible total score ranging from 0 to 12 units.
Measured: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in the Social Environment for Responsible Gambling
This outcome will measure changes in Changes in the Social Environment using 3 items (questions 35-37) that assess participants' ability to seek support from their social network. Items are scored on a 5-point Likert scale from 0 (not at all sure) to 4 (completely sure), with a possible total score ranging from 0 to 12 units.
Measured: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Initiation of Responsible Gambling Behaviors
This outcome will measure the overall Initiation using 3 items (questions 38-40) assessing participants' likelihood of initiating responsible gambling. Items are scored on a 5-point Likert scale from 0 (not at all likely) to 4 (completely likely), with a possible total score range of 0 to 12 units.
Measured: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Sustenance of Responsible Gambling Behaviors
This outcome will measure the overall Sustenance using 3 items (questions 41-43) assessing participants' likelihood of continuing responsible gambling. Items are scored on a 5-point Likert scale from 0 (not at all likely) to 4 (completely likely), with a possible total score range of 0 to 12 units.
Measured: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups-the MTM-based ResponsiblePlay© intervention group and the knowledge-based intervention group, which will run in parallel.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manoj Sharma, University of Nevada, Las Vegas
- Investigators
- Manoj Sharma, PhD, Principal investigator, University of Nevada, Las Vegas (UNLV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642155
- Sponsor's protocol ID
- UNLV-2024-507
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) that underlie the results reported in published articles will be shared, including data dictionaries. Data will be anonymized to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of ResponsiblePlay©: MTM-Based Intervention for Responsible Gambling for College Students
- ClinicalTrials.gov ID
- NCT06642155
- Acronym / sponsor ID
- UNLV-2024-507
- Keywords
- Responsible Gambling, College Students, Problem Gambling, Pathological Gambling, Behavioral Interventions, Health Behavior Change, Multi-theory Model (MTM), Randomized Controlled Trial (RCT)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if the RESPONSIBLEPLAY© intervention helps promote responsible gambling behaviors in University of Nevada, Las Vegas (UNLV) students aged 21 and older who have a Problem Gambling Severity Index (PGSI) score of 3 or higher. The main questions it aims to answer are:
Does the intervention reduce harmful gambling behaviors? Does the intervention increase responsible gambling practices? Researchers will compare participants receiving the RESPONSIBLEPLAY© intervention with those receiving a knowledge-based intervention to see if the RESPONSIBLEPLAY© intervention is more effective.
Participants will:
Attend three face-to-face sessions on responsible gambling over three weeks. Complete surveys before, after, and eight weeks after the intervention to track their progress.
Detailed description
This study investigates the efficacy of the RESPONSIBLEPLAY© intervention, designed to promote responsible gambling behaviors among college students at UNLV. College students are a vulnerable group for developing gambling-related problems, with a significantly higher prevalence of problem and pathological gambling compared to the general population. This randomized controlled trial (RCT) will compare the RESPONSIBLEPLAY© intervention, which is based on the Multi-theory Model (MTM) of health behavior change, to a traditional knowledge-based intervention.
The RESPONSIBLEPLAY© intervention addresses both the initiation and sustenance of behavior change, incorporating elements such as participatory dialogue, behavioral confidence, and changes in the social and physical environments. The intervention aims to equip participants with practical strategies to manage and limit gambling behaviors.
The study will take place over a three-week period, with face-to-face sessions designed to engage participants in discussions and self-guided activities that promote responsible gambling. Follow-up assessments will be conducted at eight weeks post-intervention to evaluate the long-term impact of the intervention. A two-factor repeated measures analysis will be used to assess changes in gambling behaviors and related psychological constructs over time.
The findings from this study may provide critical evidence to support the use of theory-based interventions to reduce gambling-related harms in a college student population, which can inform future public health strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups-the MTM-based ResponsiblePlay© intervention group and the knowledge-based intervention group, which will run in parallel.
| Arm | Type | Receives |
|---|---|---|
| RESPONSIBLEPLAY© MTM-Based Intervention | Experimental | Behavioral: RESPONSIBLEPLAY© MTM-Based InterventionParticipants will receive a theory-based intervention designed to promote responsible gambling behaviors using the Multi-theory Model (MTM) of health behavior change. The intervention focuses on both the initiation and sustenance of responsible gambling through six constructs: Participatory Dialogue: Discussing the pros and cons of responsible gambling. Behavioral Confidence: Building confidence to practice responsible gambling. Changes in the Physical Environment: Modifying surroundings to limit gambling opportunities. Emotional Transformation: Managing emotions to maintain behavior change. Practice for Change: Planning and practicing responsible gambling strategies. Changes in the Social Environment: Leveraging support from family, friends, and professionals. This intervention aims to provide practical strategies for adopting and maintaining responsible gambling behaviors. |
| Knowledge-Based Intervention | Active comparator | Behavioral: Knowledge-Based InterventionParticipants will receive educational content about the risks of gambling and strategies for responsible gambling in the form of lectures and reading materials. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be at least 21 years old.
- Must be a enrolled UNLV student.
- Must engage in gambling activities.
- Must have a score of 3 or higher on the Problem Gambling Severity Index (PGSI), indicating at-risk or problem gambling behavior.
Key exclusion criteria (3 listed)
- Participants currently receiving treatment for gambling disorders.
- Individuals with cognitive impairments that would affect their ability to provide consent or participate in the intervention.
- Individuals who are not fluent in English (since the intervention materials and assessments will be conducted in English).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESPONSIBLEPLAY© MTM-Based InterventionParticipants in this group will receive a theory-based intervention using the Multi-theory Model (MTM) of health behavior change. The intervention includes participatory dialogue, behavioral confidence-building, and strategies to modify the physical and social environments. It also incorporates emotional transformation and practice for change. Sessions will be delivered in-person over three weeks, focusing on promoting responsible gambling behaviors. | Behavioural | RESPONSIBLEPLAY© MTM-Based Intervention |
| Knowledge-Based InterventionParticipants in this group will receive a knowledge-based intervention that provides information on gambling risks and responsible gambling strategies. The intervention consists of lectures and reading materials delivered in-person over three weeks. It focuses on raising awareness of gambling risks but does not include the behavioral change strategies used in the MTM-based intervention. | Behavioural | Knowledge-Based Intervention |
Primary outcome
Change in Problem Gambling Severity Index (PGSI) Score
Time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
The primary outcome will assess changes in the Problem Gambling Severity Index (PGSI) scores, which measure the severity of gambling behavior. The PGSI includes 9 items with a score range of 0 to 27, where higher scores indicate more severe gambling issues. Scores will be collected at baseline, immediately post-intervention, and at an eight-week follow-up.
8 secondary outcomes
Change in Participatory Dialogue (Perceived Advantages Minus Perceived Disadvantages) for Responsible Gambling
Time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Behavioral Confidence for Responsible Gambling
Time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in the Physical Environment for Responsible Gambling
Time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Emotional Transformation for Responsible Gambling
Time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Practice for Change for Responsible Gambling
Time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in the Social Environment for Responsible Gambling
Time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Initiation of Responsible Gambling Behaviors
Time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Change in Sustenance of Responsible Gambling Behaviors
Time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No. Individual participant data (IPD) that underlie the results reported in published articles will be shared, including data dictionaries. Data will be anonymized to protect participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manoj Sharma, PhD principal investigator
University of Nevada, Las Vegas (UNLV)
Questions about this trial
What is this clinical trial studying?
A study testing RESPONSIBLEPLAY© MTM-Based Intervention and Knowledge-Based Intervention in people with Problem Gambling and Pathological Gambling, run by University of Nevada, Las Vegas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manoj Sharma, PhD (702-895-2687, manoj.sharma@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Problem Gambling Severity Index (PGSI) Score (time frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.