Gambling ProblemNCT06235333
Exploring a Lottery-promoted Gambling Disorder Screening Day Intervention
A study testing Gambling Disorder Screening Day screener and Gambling Disorder Screening Day information sheet in people with Gambling Problem, run by Cambridge Health Alliance.
Trial summary
The study is a randomized trial of gambling screening plus feedback (intervention) or gambling information (control) conditions, with data collection at baseline (T1) and a 3-month follow-up (T2). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gambling Problem
- What is being tested?
- Gambling Disorder Screening Day screener and Gambling Disorder Screening Day information sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for this study, participants must (1) be at least 18 years old, (2) have gambled at least monthly during the past 12 months, and (3) reside in Indiana, Kentucky, Michigan, Illinois, or Ohio.
Who cannot join
- Being from outside of U.S.
Trial locations and contacts
No sites are listed yet.
About this study
The study is a randomized trial of gambling screening plus feedback (intervention) or gambling information (control) conditions, with data collection at baseline (T1) and a 3-month follow-up (T2). Two participant recruitment strategies (i.e., Hoosier Lottery cohort and MTurk Workers cohort) will allow the investigators to compare how recruitment source relates to post-intervention gambling behavior change intentions and assorted gambling-related behavior changes. The investigators also seek to understand how experiences with screening vary for minoritized and non-minoritized people who gamble.
Read the detailed description
Gambling Disorder Screening Day (GDSD) occurs on the second Tuesday of March annually. This events is modeled after National Alcohol and Depression Screening Days, which research shows increase awareness and help-seeking for these problems. There has never been a study of the impacts of GDSD on its participants. The event is growing in popularity across Massachusetts, the U.S., and around the world, which makes its assessment imperative. Gambling operators might be able to support independent public health interventions for safer gambling due to their reach (e.g., through email marketing lists) among gamblers. Operator involvement in such efforts would help fulfill their responsibility for promoting safer gambling and help-seeking. Although limited public health expertise and opposing financial interests limit the value of operators' direct involvement in public health intervention, the value of indirect support through promoting third-party public health efforts remains an open question. Accordingly, this study considers how gambling operators might contribute to gamblers' participation in GDSD, and how it compares to another technique (e.g., MTurk) that offers high engagement.
As the event grows in popularity, it is imperative to ensure that GDSD has the intended effects, especially for high-reach supporters, such as gambling operators. This is particularly important for different types of people who might be more or less receptive to operator-promoted GDSD events. The investigators might, for example, expect to observe differences depending upon individuals' race/ethnicity status. Individuals minoritized by race/ethnicity have distinct barriers to help-seeking, including previous healthcare discrimination, lack of culturally and linguistically appropriate care, and an absence of resources and treatment opportunities designed with their unique needs and cultures in mind. Operator-promoted GDSD events, therefore, might need to be tailored to ensure reach, receptivity, and responsivity among minoritized people.
This study will provide information that can shape future gambling industry involvement in public health events, and simultaneously, complete a large (i.e., over 2,000 individuals) gambling screening. In addition, the proposed research involves a novel collaboration with an industry partner to examine a new digital protocol for gambling screening and intervention. The findings will provide new information about the efficacy of online mass screening for gambling-related problems.
Study Aims:
- Co-develop with the Hoosier Lottery a campaign to promote a new digital protocol for gambling screening and intervention study timed to coincide with GDSD 2024 promotion;
- Use a longitudinal sample of greater-Indiana gamblers to evaluate differences in GDSD reach (i.e., numbers of individuals screened), receptiveness (i.e., post-screening ratings of clarity, informativeness, relevance and helpfulness), and responsivity (i.e., changes in post-screening reports of gambling behavior and safer play intentions and behaviors) for lottery-recruited and platform-recruited (i.e., MTurk) screening participants randomized to intervention or control groups, using baseline and 3-month follow-up surveys and purposeful sampling; and,
- Conduct a moderator analysis to examine whether status as a minoritized group member interacts with recruitment pathway to shape participants' responsivity to the screening/intervention protocol.
- Conditions
- Gambling Problem
- Being tested
- Gambling Disorder Screening Day screener, Gambling Disorder Screening Day information sheet
- Keywords
- brief screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gambling Disorder Screening Day screenerBehavioural
See descriptions
Gambling Disorder Screening Day information sheetBehavioural
See descriptions
| Study group | Role | What they receive |
|---|---|---|
| Screening Intervention | Experimental | Individuals will take part in a branching problem/responsible gambling information sharing experience before completing a multi-item brief gambling screen and receiving tailored feedback about their risk for gambling-related problems, and including problem/responsible gambling resources for their state of residence and national resources. Receives: Behavioral: Gambling Disorder Screening Day screener |
| Informational Control | Active comparator | Individuals will take part in a limited problem/responsible gambling information sharing experience. Receives: Behavioral: Gambling Disorder Screening Day information sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
At Time 1, the investigators will count the number of individuals who elect to launch the GDSD screening protocol.
Measured: Time 1 (March 12, 2024)
Protocol Feedback.
At Time 1, the investigators will ask participants to indicate the extent to which they agree that specific parts of the GDSD protocol are (1) clear, (2) informative, (3) relevant, and (4) helpful. Participants will make ratings on a 5-point scale ranging from Strongly Disagree to Strongly Agree.
Measured: Time 1 (March 12, 2024)
Gambling Frequency.
At Time 1 and Time 2, the investigators will assess past three-months gambling behavior. The investigators will ask participants to indicate the frequency with which they engaged in six gambling activities (e.g., Lottery/Scratch Tickets; Poker, Casino Table Games; Sports; Slots/Keno; Other) in the past 3 months on a scale from Never (0) to More than Once a Week (6). For some analyses, the investigators will assign individuals a single 3-month frequency score (range 0-6) by identifying individuals' maximum frequency playing any game during the past three months.
Measured: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
Gambling Intentions.
At Time 1, the investigators will inquire about participants' future gambling intentions by asking them to report how much they expect they will gamble on six types of gambling games during the next three months using the same frequency scale adapted for future gambling.
Measured: Time 1 (March 12, 2024)
Guidelines Compliance.
At Time 1 and Time 2, the investigators will ask participants to report, to the best of their recollection, whether they have complied with three Lower Risk Gambling Guidelines [LRGG; 21] during the previous three months: (1) Gambled no more than 1% of household income before tax per month, (2) Gambled no more than four days per month, and (3) Avoided regularly gambling at more than two types of games.
Participants will indicate that they have complied with a practice, have not complied, or do not know. For some analyses, the investigators will assign individuals a single compliance score (0-3) by summing the number of guidelines with which an individual complied during the past three months.
Measured: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
Guidelines Intentions.
At Time 1, the investigators will ask participants to report their intentions for following the three LRGG during the next three months. Participants will make ratings on a 5-point scale ranging from Extremely Unlikely to Extremely Likely.
Measured: Time 1 (March 12, 2024)
Safer Gambling Practices.
At Time 1 and Time 2, the investigators will ask participants to report, to the best of their recollection, whether they have engaged in six safer gambling practices [21] during the previous three months: (1) limit your consumption of alcohol, cannabis and other drugs while gambling; (2) limit your access to money; (3) schedule activities right after gambling sessions, which can set a limit on the amount of time you have to gamble; (4) think about how having gambling companions or gambling alone might impact you; (5) keep in mind how much money you are able to spend on entertainment when deciding how much to gamble; and, (6) plan ahead and set limits. Participants will indicate that they have engaged in a practice, have not engaged, or do not know. For some analyses, the investigators will assign individuals a single safer gambling score (0-6) by summing the number of safer gambling practices with which an individual engaged during the past three months.
Measured: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
Safer Gambling Intentions.
At Time 1, the investigators will ask participants to report their intentions for engaging in the six safer gambling practices during the next three months. Participants will make ratings on a 5-point scale ranging from Extremely Unlikely to Extremely Likely.
Measured: Time 1 (March 12, 2024)
Help Seeking Behavior.
At Time 1 and Time 2, the investigators will ask participants to report whether they engaged in gambling education and gambling help-seeking activities during the past three months. Participants will indicate Yes or No to whether they have engaged with (1) a gambling self-help workbook that can be completed anonymously online; (2) a gambling self-help workbook that was mailed to their home; (3) an online gambling helpchat; (4) a phone-based gambling helpline; (5) a gambling recovery podcast; (6) a gambling recovery smartphone app; (7) Gamblers Anonymous or other mutual support groups; (8) gambling "how to" books or services; or (9) professional treatment for gambling, including a more in-depth assessment of their gambling behavior. For some analyses, the investigators will assign individuals a single help seeking score (0-9) by summing the number of help-seeking activities with which an individual engaged during the past three months.
Measured: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
Help Seeking Intentions.
At Time 1, the investigators will ask participants to indicate their likelihood of engaging in the nine gambling education and gambling help-seeking activities during the next three months. Participants will make ratings on a 5-point scale ranging from Extremely Unlikely to Extremely Likely.
Measured: Time 1 (March 12, 2024)
Positive Play Scale.
At Time 1 and Time 2, the investigators will ask participants to complete the Positive Play Scale [22] on a 3-month timeframe. The investigators will calculate Cronbach's alpha and, if the investigators observe adequate internal consistency, the investigators will calculate its four subscale scores by summing.
Measured: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start12 Mar 2024 (estimated)
- Primary completion12 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling ProblemStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two possible conditions: (1) intervention, which consists of a branching responsible/problem gambling information and gambling screening experience and (20 control, which consists of limited responsible/problem gambling information experience.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Responsible Gaming, Hoosier Lottery, Indiana
- Responsible party
- Principal investigator, Debi LaPlante, Cambridge Health Alliance
- Investigators
- Debi A. LaPlante, PhD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235333
- Sponsor's protocol ID
- 13656
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share data on the Division on Addiction Transparency Project website.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring a Lottery-promoted Gambling Disorder Screening Day Intervention
- ClinicalTrials.gov ID
- NCT06235333
- Acronym / sponsor ID
- 13656
- Conditions
- Gambling Problem
- Keywords
- brief screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- National Center for Responsible Gaming, Hoosier Lottery, Indiana
- Study start
- 12 Mar 2024 (estimated)
- Primary completion
- 12 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Jan 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 study is a randomized trial of gambling screening plus feedback (intervention) or gambling information (control) conditions, with data collection at baseline (T1) and a 3-month follow-up (T2). Two participant recruitment strategies (i.e., Hoosier Lottery cohort and MTurk Workers cohort) will allow the investigators to compare how recruitment source relates to post-intervention gambling behavior change intentions and assorted gambling-related behavior changes. The investigators also seek to understand how experiences with screening vary for minoritized and non-minoritized people who gamble.
Detailed description
Gambling Disorder Screening Day (GDSD) occurs on the second Tuesday of March annually. This events is modeled after National Alcohol and Depression Screening Days, which research shows increase awareness and help-seeking for these problems. There has never been a study of the impacts of GDSD on its participants. The event is growing in popularity across Massachusetts, the U.S., and around the world, which makes its assessment imperative. Gambling operators might be able to support independent public health interventions for safer gambling due to their reach (e.g., through email marketing lists) among gamblers. Operator involvement in such efforts would help fulfill their responsibility for promoting safer gambling and help-seeking. Although limited public health expertise and opposing financial interests limit the value of operators' direct involvement in public health intervention, the value of indirect support through promoting third-party public health efforts remains an open question. Accordingly, this study considers how gambling operators might contribute to gamblers' participation in GDSD, and how it compares to another technique (e.g., MTurk) that offers high engagement.
As the event grows in popularity, it is imperative to ensure that GDSD has the intended effects, especially for high-reach supporters, such as gambling operators. This is particularly important for different types of people who might be more or less receptive to operator-promoted GDSD events. The investigators might, for example, expect to observe differences depending upon individuals' race/ethnicity status. Individuals minoritized by race/ethnicity have distinct barriers to help-seeking, including previous healthcare discrimination, lack of culturally and linguistically appropriate care, and an absence of resources and treatment opportunities designed with their unique needs and cultures in mind. Operator-promoted GDSD events, therefore, might need to be tailored to ensure reach, receptivity, and responsivity among minoritized people.
This study will provide information that can shape future gambling industry involvement in public health events, and simultaneously, complete a large (i.e., over 2,000 individuals) gambling screening. In addition, the proposed research involves a novel collaboration with an industry partner to examine a new digital protocol for gambling screening and intervention. The findings will provide new information about the efficacy of online mass screening for gambling-related problems.
Study Aims:
- Co-develop with the Hoosier Lottery a campaign to promote a new digital protocol for gambling screening and intervention study timed to coincide with GDSD 2024 promotion;
- Use a longitudinal sample of greater-Indiana gamblers to evaluate differences in GDSD reach (i.e., numbers of individuals screened), receptiveness (i.e., post-screening ratings of clarity, informativeness, relevance and helpfulness), and responsivity (i.e., changes in post-screening reports of gambling behavior and safer play intentions and behaviors) for lottery-recruited and platform-recruited (i.e., MTurk) screening participants randomized to intervention or control groups, using baseline and 3-month follow-up surveys and purposeful sampling; and,
- Conduct a moderator analysis to examine whether status as a minoritized group member interacts with recruitment pathway to shape participants' responsivity to the screening/intervention protocol.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- There are two possible conditions: (1) intervention, which consists of a branching responsible/problem gambling information and gambling screening experience and (20 control, which consists of limited responsible/problem gambling information experience.
| Arm | Type | Receives |
|---|---|---|
| Screening Intervention | Experimental | Behavioral: Gambling Disorder Screening Day screenerIndividuals will take part in a branching problem/responsible gambling information sharing experience before completing a multi-item brief gambling screen and receiving tailored feedback about their risk for gambling-related problems, and including problem/responsible gambling resources for their state of residence and national resources. |
| Informational Control | Active comparator | Behavioral: Gambling Disorder Screening Day information sheetIndividuals will take part in a limited problem/responsible gambling information sharing experience. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible for this study, participants must (1) be at least 18 years old, (2) have gambled at least monthly during the past 12 months, and (3) reside in Indiana, Kentucky, Michigan, Illinois, or Ohio.
Key exclusion criteria (1 listed)
- Being from outside of U.S.
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 |
|---|---|---|
| Gambling Disorder Screening Day screenerSee descriptions | Behavioural | Screening Intervention |
| Gambling Disorder Screening Day information sheetSee descriptions | Behavioural | Informational Control |
Primary outcome
Reach
Time frame: Time 1 (March 12, 2024)
At Time 1, the investigators will count the number of individuals who elect to launch the GDSD screening protocol.
Protocol Feedback.
Time frame: Time 1 (March 12, 2024)
At Time 1, the investigators will ask participants to indicate the extent to which they agree that specific parts of the GDSD protocol are (1) clear, (2) informative, (3) relevant, and (4) helpful. Participants will make ratings on a 5-point scale ranging from Strongly Disagree to Strongly Agree.
Gambling Frequency.
Time frame: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
At Time 1 and Time 2, the investigators will assess past three-months gambling behavior. The investigators will ask participants to indicate the frequency with which they engaged in six gambling activities (e.g., Lottery/Scratch Tickets; Poker, Casino Table Games; Sports; Slots/Keno; Other) in the past 3 months on a scale from Never (0) to More than Once a Week (6). For some analyses, the investigators will assign individuals a single 3-month frequency score (range 0-6) by identifying individuals' maximum frequency playing any game during the past three months.
Gambling Intentions.
Time frame: Time 1 (March 12, 2024)
At Time 1, the investigators will inquire about participants' future gambling intentions by asking them to report how much they expect they will gamble on six types of gambling games during the next three months using the same frequency scale adapted for future gambling.
Guidelines Compliance.
Time frame: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
At Time 1 and Time 2, the investigators will ask participants to report, to the best of their recollection, whether they have complied with three Lower Risk Gambling Guidelines [LRGG; 21] during the previous three months: (1) Gambled no more than 1% of household income before tax per month, (2) Gambled no more than four days per month, and (3) Avoided regularly gambling at more than two types of games. Participants will indicate that they have complied with a practice, have not complied, or do not know. For some analyses, the investigators will assign individuals a single compliance score (0-3) by summing the number of guidelines with which an individual complied during the past three months.
Guidelines Intentions.
Time frame: Time 1 (March 12, 2024)
At Time 1, the investigators will ask participants to report their intentions for following the three LRGG during the next three months. Participants will make ratings on a 5-point scale ranging from Extremely Unlikely to Extremely Likely.
Safer Gambling Practices.
Time frame: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
At Time 1 and Time 2, the investigators will ask participants to report, to the best of their recollection, whether they have engaged in six safer gambling practices [21] during the previous three months: (1) limit your consumption of alcohol, cannabis and other drugs while gambling; (2) limit your access to money; (3) schedule activities right after gambling sessions, which can set a limit on the amount of time you have to gamble; (4) think about how having gambling companions or gambling alone might impact you; (5) keep in mind how much money you are able to spend on entertainment when deciding how much to gamble; and, (6) plan ahead and set limits. Participants will indicate that they have engaged in a practice, have not engaged, or do not know. For some analyses, the investigators will assign individuals a single safer gambling score (0-6) by summing the number of safer gambling practices with which an individual engaged during the past three months.
Safer Gambling Intentions.
Time frame: Time 1 (March 12, 2024)
At Time 1, the investigators will ask participants to report their intentions for engaging in the six safer gambling practices during the next three months. Participants will make ratings on a 5-point scale ranging from Extremely Unlikely to Extremely Likely.
Help Seeking Behavior.
Time frame: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
At Time 1 and Time 2, the investigators will ask participants to report whether they engaged in gambling education and gambling help-seeking activities during the past three months. Participants will indicate Yes or No to whether they have engaged with (1) a gambling self-help workbook that can be completed anonymously online; (2) a gambling self-help workbook that was mailed to their home; (3) an online gambling helpchat; (4) a phone-based gambling helpline; (5) a gambling recovery podcast; (6) a gambling recovery smartphone app; (7) Gamblers Anonymous or other mutual support groups; (8) gambling "how to" books or services; or (9) professional treatment for gambling, including a more in-depth assessment of their gambling behavior. For some analyses, the investigators will assign individuals a single help seeking score (0-9) by summing the number of help-seeking activities with which an individual engaged during the past three months.
Help Seeking Intentions.
Time frame: Time 1 (March 12, 2024)
At Time 1, the investigators will ask participants to indicate their likelihood of engaging in the nine gambling education and gambling help-seeking activities during the next three months. Participants will make ratings on a 5-point scale ranging from Extremely Unlikely to Extremely Likely.
Positive Play Scale.
Time frame: Time 1 (March 12, 2024) and Time 2 (June 12, 2024)
At Time 1 and Time 2, the investigators will ask participants to complete the Positive Play Scale [22] on a 3-month timeframe. The investigators will calculate Cronbach's alpha and, if the investigators observe adequate internal consistency, the investigators will calculate its four subscale scores by summing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Yes. The investigators will share data on the Division on Addiction Transparency Project website.
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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. This study is not recruiting at the moment.
Debi A. LaPlante, PhD principal investigator
Cambridge Health Alliance
Questions about this trial
What is this clinical trial studying?
A study testing Gambling Disorder Screening Day screener and Gambling Disorder Screening Day information sheet in people with Gambling Problem, run by Cambridge Health Alliance.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debi A LaPlante, PhD (617-575-5677, dlaplante@cha.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: Time 1 (March 12, 2024)). The study lists 11 primary outcomes in all. 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 31 Jan 2024.