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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA030017 | U.S. NIH Grant/Contract | View source |
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Grant was terminated by NIH.
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This is a randomized controlled trial to examine the efficacy of a game-based intervention to reduce alcohol-related harms among sexual and gender minority youth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Singularities Game | Experimental | Singularities is an online game. |
|
| Food4Thought | Active Comparator | Food4Thought is an attention control condition in which we provide participants with similar amounts of research team contact and program contact as the intervention. Participants will play the game Pick Your Plate! A Global Guide to Nutrition, developed by the Smithsonian Science Education Center. Participants are instructed to build healthy meals using cuisine from around the world while ensuring they stick to a budget and meet all their nutritional needs. Food4Thought will be delivered via Qualtrics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Singularities Game | Behavioral | Singularities is a theory-based, community-informed, web-accessible, roleplaying game-based intervention incorporating 4 primary components: fostering healthy identity development in a safe environment; encouraging help-seeking behaviors; encouraging use of productive coping; alcohol-harm reduction; and encouraging healthy internet and social media use. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol-related Harms | Primary outcome is alcohol-related harms defined as the frequency of 19 total harms (e.g., Hangover after drinking, Unable to remember what happened after drinking, Had sex that you later regretted, Trouble with parent(s) because of drinking Physical fight because you were affected by alcohol, Drove in a vehicle after drinking) as measured in the School Health and Alcohol Harm Reduction Project (SHAHRP) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Drinking Quantity | Number of drinks consumed on a typical day of drinking in the past three months via Quantity-Frequency items | 3 months |
| Drinking Frequency | Number of days on which one or more drinks were consumed in past month via Quantity-Frequency items. |
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Inclusion Criteria:
Exclusion Criteria:
Any gender minorities are eligible as are any cisgender sexual minority people.
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| Name | Affiliation | Role |
|---|---|---|
| Robert WS Coulter, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
Data sharing plan and archiving of de-identified data as required by NIH
12 months after end of study
Public
Trial was terminated before all enrolled participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Singularities Game | Singularities is an online game. |
| FG001 | Food4Thought | Food4Thought is an attention control condition in which we provide participants with similar amounts of research team contact and program contact as the intervention. Participants will play the game Pick Your Plate! A Global Guide to Nutrition, developed by the Smithsonian Science Education Center. Participants are instructed to build healthy meals using cuisine from around the world while ensuring they stick to a budget and meet all their nutritional needs. Food4Thought will be delivered via Qualtrics. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Trial was terminated before all enrolled participants were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Singularities Game | Singularities is an online game. |
| BG001 | Food4Thought | Food4Thought is an attention control condition in which we provide participants with similar amounts of research team contact and program contact as the intervention. Participants will play the game Pick Your Plate! A Global Guide to Nutrition, developed by the Smithsonian Science Education Center. Participants are instructed to build healthy meals using cuisine from around the world while ensuring they stick to a budget and meet all their nutritional needs. Food4Thought will be delivered via Qualtrics. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol-related Harms | Primary outcome is alcohol-related harms defined as the frequency of 19 total harms (e.g., Hangover after drinking, Unable to remember what happened after drinking, Had sex that you later regretted, Trouble with parent(s) because of drinking Physical fight because you were affected by alcohol, Drove in a vehicle after drinking) as measured in the School Health and Alcohol Harm Reduction Project (SHAHRP) | Trial was terminated before the outcome measure data were collected | Posted | 3 months |
|
From enrollment until termination of trial, approximately 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Singularities Game | Singularities is an online game. | 0 |
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The effect of the intervention cannot be determined due to termination of the trial by NIH before any outcome data were collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Coulter | University of Pittsburgh | 412.624.0647 | rwc19@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2025 | Feb 12, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2024 | Feb 8, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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Two-armed parallel randomized controlled trial
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|
| Food4Thought | Behavioral | Food4Thought is an attention control condition in which we provide participants with similar amounts of research team contact and program contact as the intervention. Participants will play the game Pick Your Plate! A Global Guide to Nutrition, developed by the Smithsonian Science Education Center. Participants are instructed to build healthy meals using cuisine from around the world while ensuring they stick to a budget and meet all their nutritional needs. Food4Thought will be delivered via Qualtrics. |
|
| 3 months |
| Binge Drinking | Number of times where 4 or 5+ drinks (asking both, regardless of assigned/biological sex at birth to be inclusive of gender minorities) were consumed in a 2-hour period over the past 3 months, via NIAAA items | 3 months |
| Alcohol Use Initiation | Survey item from the Youth Risk Behavior Survey assessing lifetime alcohol use. | 3 months |
| Alcohol Harm Reduction Skills | Which behaviors are engaged in while drinking or partying, measured with the Protective Behavioral Strategies Scale (PBSS). Scores range from 20 to 120, with higher scores indicating more skills used | 3 months |
| Bystander Alcohol Harm Reduction Skills | Total # of times a specific strategy was used to help others before, during, or after drinking, using the Strategies subscale of the Bystanders to Alcohol Risk Scale (BARS). Scores range from 0 to 27, with higher scores indicating more skills used | 3 months |
| Emotional Distress Tolerance Skills | Beliefs about feeling distressed or upset, measured with the Distress Tolerance Scale (DTS). Scores range from 15 to 75, with higher scores indicating a poorer outcome | 3 months |
| Emotion Regulation and Decentering Practices | How often mindfulness practices are used, measured with the Applied Mindfulness Process Scale (AMPS). Scores range from 0 to 60, with higher scores indicating a better outcome | 3 months |
| Healthy Social Media Use | Endorsement of beliefs and thoughts about social media, using MetroWest Adolescent Health Survey items | 3 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | Drinking Quantity | Number of drinks consumed on a typical day of drinking in the past three months via Quantity-Frequency items | Trial was terminated before the outcome measure data were collected. | Posted | 3 months |
|
|
| Secondary | Drinking Frequency | Number of days on which one or more drinks were consumed in past month via Quantity-Frequency items. | Trial was terminated before the outcome measure data were collected. | Posted | 3 months |
|
|
| Secondary | Binge Drinking | Number of times where 4 or 5+ drinks (asking both, regardless of assigned/biological sex at birth to be inclusive of gender minorities) were consumed in a 2-hour period over the past 3 months, via NIAAA items | Trial was terminated before the outcome measure data were collected. | Posted | 3 months |
|
|
| Secondary | Alcohol Use Initiation | Survey item from the Youth Risk Behavior Survey assessing lifetime alcohol use. | Trial was terminated before the outcome measure data were collected. | Posted | 3 months |
|
|
| Secondary | Alcohol Harm Reduction Skills | Which behaviors are engaged in while drinking or partying, measured with the Protective Behavioral Strategies Scale (PBSS). Scores range from 20 to 120, with higher scores indicating more skills used | Trial was terminated before the outcome measure data were collected. | Posted | 3 months |
|
|
| Secondary | Bystander Alcohol Harm Reduction Skills | Total # of times a specific strategy was used to help others before, during, or after drinking, using the Strategies subscale of the Bystanders to Alcohol Risk Scale (BARS). Scores range from 0 to 27, with higher scores indicating more skills used | Trial was terminated before the outcome measure data were collected. | Posted | 3 months |
|
|
| Secondary | Emotional Distress Tolerance Skills | Beliefs about feeling distressed or upset, measured with the Distress Tolerance Scale (DTS). Scores range from 15 to 75, with higher scores indicating a poorer outcome | Trial was terminated before the outcome measure data were collected. | Posted | 3 months |
|
|
| Secondary | Emotion Regulation and Decentering Practices | How often mindfulness practices are used, measured with the Applied Mindfulness Process Scale (AMPS). Scores range from 0 to 60, with higher scores indicating a better outcome | Trial was terminated before the outcome measure data were collected. | Posted | 3 months |
|
|
| Secondary | Healthy Social Media Use | Endorsement of beliefs and thoughts about social media, using MetroWest Adolescent Health Survey items | Trial was terminated before the outcome measure data were collected. | Posted | 3 months |
|
|
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Food4Thought | Food4Thought is an attention control condition in which we provide participants with similar amounts of research team contact and program contact as the intervention. Participants will play the game Pick Your Plate! A Global Guide to Nutrition, developed by the Smithsonian Science Education Center. Participants are instructed to build healthy meals using cuisine from around the world while ensuring they stick to a budget and meet all their nutritional needs. Food4Thought will be delivered via Qualtrics. | 0 | 10 | 0 | 10 | 0 | 10 |
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