NCT06642155

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

October 13, 2024

Last Update Submit

October 16, 2024

Conditions

Keywords

Responsible GamblingCollege StudentsProblem GamblingPathological GamblingBehavioral InterventionsHealth Behavior ChangeMulti-theory Model (MTM)Randomized Controlled Trial (RCT)Public Health InterventionGambling Disorder Prevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)

  • Change in Behavioral Confidence for Responsible Gambling

    Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)

  • Change in the Physical Environment for Responsible Gambling

    Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)

  • Change in Emotional Transformation for Responsible Gambling

    Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)

  • Change in Practice for Change for Responsible Gambling

    Baseline, immediately post-intervention (Week 3), and eight-week follow-up (Week 11)

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Knowledge-Based Intervention

Interventions

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.

RESPONSIBLEPLAY© MTM-Based Intervention

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.

Knowledge-Based Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Manoj Sharma, PhD

    University of Nevada, Las Vegas (UNLV)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manoj Sharma, PhD

CONTACT

Sidath C Kapukotuwa, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will not be aware of whether they are receiving the ResponsiblePlay© intervention or the knowledge-based intervention. This single-blind design helps reduce bias related to participants' expectations.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Chair

Study Record Dates

First Submitted

October 13, 2024

First Posted

October 15, 2024

Study Start

November 1, 2024

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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.