- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06642155
Theory-based Intervention for Promoting Responsible Gambling Among College Students
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.
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Manoj Sharma, PhD
- Phone Number: 702-895-2687
- Email: manoj.sharma@unlv.edu
Study Contact Backup
- Name: Sidath C Kapukotuwa, MS
- Phone Number: 725-400-1780
- Email: sidath.k@unlv.edu
Study Locations
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Nevada
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Las Vegas, Nevada, United States, 89119
- University of Neavda, Las Vegas (UNLV)
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Contact:
- Sidath C Kapukotuwa, MS
- Phone Number: 725-400-1780
- Email: sidath.k@unlv.edu
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Contact:
- Manoj Sharma, Ph.D.
- Phone Number: 702-895-2687
- Email: manoj.sharma@unlv.edu
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Principal Investigator:
- Manoj Sharma, Ph.D.
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Sub-Investigator:
- Sidath Kapukotuwa, MS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RESPONSIBLEPLAY© MTM-Based Intervention
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. |
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.
|
|
Active Comparator: Knowledge-Based Intervention
Participants will receive educational content about the risks of gambling and strategies for responsible gambling in the form of lectures and reading materials.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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. |
Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
|
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Change in Behavioral Confidence for Responsible Gambling
Time Frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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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.
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Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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Change in the Physical Environment for Responsible Gambling
Time Frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
|
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.
|
Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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Change in Emotional Transformation for Responsible Gambling
Time Frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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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.
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Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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Change in Practice for Change for Responsible Gambling
Time Frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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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.
|
Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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Change in the Social Environment for Responsible Gambling
Time Frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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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.
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Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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Change in Initiation of Responsible Gambling Behaviors
Time Frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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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.
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Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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Change in Sustenance of Responsible Gambling Behaviors
Time Frame: Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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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.
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Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manoj Sharma, PhD, University of Nevada, Las Vegas (UNLV)
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNLV-2024-507
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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