Alcohol DrinkingNCT03884478
A Gamified, Social Media Inspired Personalized Normative Feedback Alcohol Intervention for Sexual Minority Women
A study testing Personalized Normative Feedback in people with Alcohol Drinking and Alcohol Abuse, run by Loyola Marymount University at 1 site in United States.
Trial summary
Sexual minority women in the United States are more likely to drink alcohol, engage in heavy drinking, and experience alcohol-related problems than are heterosexual women. Yet, to date, no evidence-based intervention or prevention efforts have been developed to reduce alcohol consumption among female sexual minority… Read more about this study
- Who is it for?
- Ages 21 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Abuse, Alcohol; Harmful Use
- What is being tested?
- Personalized Normative Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2019to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Registered for the online competition
- Accept the competition's Terms of Service \& Privacy Policy
- Endorses a lesbian, bisexual, or queer female sexual identity
- Is between the ages of 21 and 55 years
- Has consumed 3 or more drinks on at least one occasion during the previous 2 months OR consumes alcohol 3 or more days per week
- Lives in North America (US or Canada)
- Does not have a partner or housemate participating
- Accepts invitation and consents to participate in the Evaluation Study
Who cannot join
- Does not register for the online competition.
- Does not accept the competition's Terms of Service \& Privacy Policy
- Is younger than 21 years of age or older than 55 years of age.
- Has NOT consumed 3 or more drinks on at least one occasion during the previous 2 months AND drinks less than 3 days per week
- Lives outside of North America
- Has a partner or housemate participating
- Declines invitation
- Does not consent to participate in the Evaluation Study
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola Marymount University
Los Angeles, California, 90045
About this study
Official title: PNF 2.0: A Novel, Gamified, Facebook-Integrated Personalized Normative Feedback Intervention to Reduce Alcohol Use and Negative Consequences Among Sexual Minority Women
Sexual minority women in the United States are more likely to drink alcohol, engage in heavy drinking, and experience alcohol-related problems than are heterosexual women. Yet, to date, no evidence-based intervention or prevention efforts have been developed to reduce alcohol consumption among female sexual minority community members. The proposed research seeks to narrow the disparity in alcohol intervention research by examining an innovative gamified personalized normative feedback (PNF) intervention to reduce drinking among sexual minority women found to frequent social media sites and overestimate norms related to peers' general alcohol use and drinking to cope with sexual minority stigma. The newly developed GANDR (Gamified Alcohol Norm Discovery and Readjustment) PNF format takes the well-established core components of a PNF alcohol intervention and delivers these components within an inviting, social media inspired, culturally-tailored online competition. This incognito intervention format is designed to be more appealing, engaging, believable, positively received, and thus effective than standard web-based PNF. The version developed for sexual minority women delivers PNF on alcohol use and stigma-coping behaviors within the context of an online game about sexual minority female stereotypes. Following two introductory rounds of play by a large cohort of sexual minority women, a sub-sample of 500 sexual minority female drinkers will be invited to participate in an evaluation study. Study participants will be randomized to receive 1 of 3 unique sequences of feedback (i.e., Alcohol \& Stigma-Coping, Alcohol \& Control, or Control topics only) during 2 intervention rounds taking place over a 6-month period. The randomized feedback sequences and multiple rounds of play will allow the research team to evaluate whether PNF on alcohol use reduces sexual minority women's alcohol consumption and negative consequences relative to PNF on control topics (AIM 2: H1), examine whether providing PNF on stigma-coping behaviors in addition to alcohol use further reduces alcohol use and consequences beyond alcohol PNF alone (AIM 2: H2), and identify mediators and moderators of intervention effectiveness (AIM 3).
Read the detailed description
This incognito alcohol intervention is culturally tailored to appeal to heavy social media using sexual minority women residing in the US and ranging in age from 21 to 55 years. Personalized normative feedback on sexual identity and age specific descriptive drinking and stigma-coping norms are delivered to players within the context of an online competition designed to challenge sexual minority women stereotypes and increase visibility. To increase the believability of the normative statistics, players create a social media-inspired profile at registration which includes an optional photo, brief bio, links to social media accounts, and other basic information. Registered players are able to browse the profiles of others and actual norms for all topics are transparently generated by the responses of players taking part in the competition. To increase motivation and engagement, each monthly round of the competition features a point-based reward system, a leader board, and a cash prize that is awarded to the top scorer who demonstrates the greatest accuracy in perceptions of peers. To decrease defensive reactions and increase appeal, feedback topics are ostensibly selected by chance in the game with treatment PNF on alcohol use and stigma-coping behaviors delivered alongside feedback on control topics of high interest to community members (e.g., style, relationships, sex, etc.). Appeal and credibility are also gained through sponsorship and promotion of the competition by several collaborating community organizations trusted as sources for health and social information by sexual minority women.
One round of the game is played each month over a 8 month period. Players are encouraged to browse player profiles before each round and it is made clear that the goal is to grow one's score by submitting accurate guesses and strategic bets on the responses of other players in one's age and sexual identity group. Each round includes questions about 2 to 3 topics ostensibly selected by a slot machine like spinner. For each topic, players make guesses about the behaviors and experiences of other players in their age and sexual identity group, choose amounts of points to bet on these guesses being true of the group, and then contribute to actual group norms by answering parallel questions. Each round is "open" for 30 days. Once closed, players are sent a text message containing a private link at which they can see detailed results (PNF) for the round, view the leaderboard and cash prize winner, and play the next round.
Packaging this intervention as a fun, identity-relevant competition for sexual minority women rather than a transparent alcohol intervention study allows feasibility and efficacy to be evaluated simultaneously, with a high degree of ecological validity. First, 1200 sexual minority women will be recruited to take part in the online competition. No participation-based incentives will be offered to players beyond the opportunity to compete for a variable cash prize each round. Then, following two initial rounds of play, a sub-sample of 500 drinkers will be invited to take part in an incentivized evaluation study after answering alcohol use questions in Round 3. Upon consenting to participate in the evaluation study, participants will be randomized to receive 1 of 3 unique sequences of feedback (i.e., Alcohol \& Stigma-Coping, Alcohol \& Control, or Control only) during intervention Rounds 3 and 4. Short-term reductions in alcohol use will be assessed in Round 6 of the competition where players will be prompted to guess, bet on, and answer alcohol use and control topic questions for a second time (i.e., Replay Bonus Round; 2 month follow-up). Following all rounds of the competition, a short survey will assess the alcohol use and negative consequences of Evaluation Study participants a final time (4 month follow-up).
Feasibility analysis will examine engagement with the online competition platform and sustainability of play in the absence of traditional study participation incentives among players not involved in the Evaluation Study. Efficacy analysis will focus on study participants randomly assigned to 1 of the 3 feedback conditions in order to: 1) evaluate whether PNF on alcohol use reduces sexual minority women's alcohol consumption and negative consequences relative to PNF on control topics; 2) examine whether providing PNF on stigma-coping behaviors in addition to alcohol use further reduces alcohol use and consequences beyond alcohol PNF; and, 3) identify mediators and moderators of intervention effectiveness.
- Conditions
- Alcohol Drinking, Alcohol Abuse, Alcohol; Harmful Use
- Being tested
- Personalized Normative Feedback
- Keywords
- Social Norms, Personalized Normative Feedback, Sexual Minority Women
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Normative FeedbackBehavioural
Personalized Normative Feedback (PNF) is a popular social norms-based intervention strategy which presents individuals with a personalized, individual report designed to correct misperceived peer norms using a graphical display. Bar charts compare actual alcohol use statistics for the peer group to A) participants' estimates of peer drinking and, B) their own self-reported drinking.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol + Stigma Coping PNF | Experimental | Participants randomized to this condition will receive gamified personalized normative feedback on their alcohol use after answering questions about alcohol use and two control topics in Round 3. Then, in the very next Round of the competition (Round 4), these participants will receive gamified personalized normative feedback on their stigma coping behaviors after answering questions about their stigma coping behaviors and two control topics. Receives: Behavioral: Personalized Normative Feedback |
| Alcohol + Control PNF | Experimental | Participants randomized to this condition will receive gamified personalized normative feedback on their alcohol use after answering questions about alcohol use and control topics in Round 3. Then, in the very next Round of the competition (Round 4), these participants will receive gamified personalized normative feedback on one control topic (Relationships) after answering questions about their stigma coping behaviors and two control topics. Receives: Behavioral: Personalized Normative Feedback |
| Control PNF | Other | Participants randomized to the control arm will answer questions about the same topics as participants in the other conditions in Round 3 (Alcohol Use \& Control) and Round 4 (Stigma-Coping \& Control). However, in both Rounds 3 and 4 they will receive gamified PNF on control topics. Receives: Behavioral: Personalized Normative Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Drinks Per Week From Baseline to the the 2 Month Follow-up
At baseline and the 2 month follow-up, items assessing drinking days per week and average drinks per occasion were multiplied in order to compute number of drinks per week. These items come from the Frequency, Quantity, Max (FQM) measure. [Baer J, S. Etiology and secondary prevention of alcohol problems with young adults. Baer J S, Marlatt G A, McMahon R, J, editors. Newbury Park: Sage; 1993.] To compute the outcome, the 2 month measure of drinks per week was subtracted from the baseline measure of drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Measured: 2 months
Change in Number of Drinks Per Week From Baseline to the 4 Month Follow-up
At baseline and the 4 month follow-up, items assessing drinking days per week and average drinks per occasion were multiplied in order to compute number of drinks per week. These items come from the Frequency, Quantity, Max (FQM) measure. [Baer J, S. Etiology and secondary prevention of alcohol problems with young adults. Baer J S, Marlatt G A, McMahon R, J, editors. Newbury Park: Sage; 1993.] To compute the outcome, the 4 month measure of drinks per week was subtracted from the baseline measure of drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Measured: 4 months
Change in Peak Drinks on One Occasion From Baseline to the 2 Months Follow-up
At baseline and the 2 month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. [Baer J, S. Etiology and secondary prevention of alcohol problems with young adults. Baer J S, Marlatt G A, McMahon R, J, editors. Newbury Park: Sage; 1993.] To compute the outcome, the 2 month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Measured: 2 months
Change in Peak Drinks on One Occasion From Baseline to the 4 Month Follow-up
At baseline and the 4 month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. [Baer J, S. Etiology and secondary prevention of alcohol problems with young adults. Baer J S, Marlatt G A, McMahon R, J, editors. Newbury Park: Sage; 1993.] To compute the outcome, the 4 month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Measured: 4 months
Change in Number of Negative Alcohol-related Consequences From Baseline to the 2 Month Follow-up
At baseline and the 2 month follow-up, a single item assessed the number of negative alcohol-related consequences experienced out of a list of 8 common negative alcohol-related consequences. This item is adapted from Riley BB, Hughes TL, Wilsnack SC. Validating a hazardous drinking index in a sample of sexual minority women: Reliability, validity, and predictive accuracy. Substance Use and Misuse. 2017;52(1):43-51. doi: 10.1080/10826084.2016.1214150.] To compute the outcome, the 2 month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Measured: 2 months
Change in Number of Negative Alcohol-related Consequences From Baseline to the 4 Month Follow-up
At baseline and the 4 month follow-up, a single item assessed the number of negative alcohol-related consequences experienced out of a list of 8 common negative alcohol-related consequences. This item is adapted from Riley BB, Hughes TL, Wilsnack SC. Validating a hazardous drinking index in a sample of sexual minority women: Reliability, validity, and predictive accuracy. Substance Use and Misuse. 2017;52(1):43-51. doi: 10.1080/10826084.2016.1214150.] To compute the outcome, the 4 month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start6 Feb 2019
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies 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
- The web app is programmed to invite an eligible sub-sample of participants from the larger population to take part in an evaluation study during the competition's 3rd monthly round. Those who consent to participate are automatically randomized by Qualtrics Research Suite to receive 1 of 3 unique sequences of feedback (i.e., Alcohol \& Stigma-Coping, Alcohol \& Control, or Control topics only) during 2 intervention rounds taking place during a 6-month period.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola Marymount University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884478
- Sponsor's protocol ID
- 1R21AA025767-01A1
- Other IDs
- 1R21AA025767-01A1
- Status last verified
- Oct 2022
- First submitted
- 14 Feb 2019
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified longitudinal dataset containing data from Evaluation Study participants at will be made available to researchers 1 year after the initial publication of results. This data set will include participant demographics and outcome measures assessed at baseline (Round 3), the 2 month follow-up (Round 6), and the 4 month follow-up (a survey following the last round of the competition). A data dictionary will be provided.
Publications
Boyle SC, LaBrie JW. A Gamified, Social Media-Inspired, Web-Based Personalized Normative Feedback Alcohol Intervention for Lesbian, Bisexual, and Queer-Identified Women: Protocol for a Hybrid Trial. JMIR Res Protoc. 2021 Apr 16;10(4):e24647. doi: 10.2196/24647.
PubMed 33861212Boyle SC, LaBrie JW, Trager BM, Costine LD. A Gamified Personalized Normative Feedback App to Reduce Drinking Among Sexual Minority Women: Randomized Controlled Trial and Feasibility Study. J Med Internet Res. 2022 May 13;24(5):e34853. doi: 10.2196/34853.
PubMed 35559854
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PNF 2.0: A Novel, Gamified, Facebook-Integrated Personalized Normative Feedback Intervention to Reduce Alcohol Use and Negative Consequences Among Sexual Minority Women
- ClinicalTrials.gov ID
- NCT03884478
- Acronym / sponsor ID
- 1R21AA025767-01A1
- Conditions
- Alcohol Drinking, Alcohol Abuse, Alcohol; Harmful Use
- Keywords
- Social Norms, Personalized Normative Feedback, Sexual Minority Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Loyola Marymount UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sexual minority women in the United States are more likely to drink alcohol, engage in heavy drinking, and experience alcohol-related problems than are heterosexual women. Yet, to date, no evidence-based intervention or prevention efforts have been developed to reduce alcohol consumption among female sexual minority community members. The proposed research seeks to narrow the disparity in alcohol intervention research by examining an innovative gamified personalized normative feedback (PNF) intervention to reduce drinking among sexual minority women found to frequent social media sites and overestimate norms related to peers' general alcohol use and drinking to cope with sexual minority stigma. The newly developed GANDR (Gamified Alcohol Norm Discovery and Readjustment) PNF format takes the well-established core components of a PNF alcohol intervention and delivers these components within an inviting, social media inspired, culturally-tailored online competition. This incognito intervention format is designed to be more appealing, engaging, believable, positively received, and thus effective than standard web-based PNF. The version developed for sexual minority women delivers PNF on alcohol use and stigma-coping behaviors within the context of an online game about sexual minority female stereotypes. Following two introductory rounds of play by a large cohort of sexual minority women, a sub-sample of 500 sexual minority female drinkers will be invited to participate in an evaluation study. Study participants will be randomized to receive 1 of 3 unique sequences of feedback (i.e., Alcohol \& Stigma-Coping, Alcohol \& Control, or Control topics only) during 2 intervention rounds taking place over a 6-month period. The randomized feedback sequences and multiple rounds of play will allow the research team to evaluate whether PNF on alcohol use reduces sexual minority women's alcohol consumption and negative consequences relative to PNF on control topics (AIM 2: H1), examine whether providing PNF on stigma-coping behaviors in addition to alcohol use further reduces alcohol use and consequences beyond alcohol PNF alone (AIM 2: H2), and identify mediators and moderators of intervention effectiveness (AIM 3).
Detailed description
This incognito alcohol intervention is culturally tailored to appeal to heavy social media using sexual minority women residing in the US and ranging in age from 21 to 55 years. Personalized normative feedback on sexual identity and age specific descriptive drinking and stigma-coping norms are delivered to players within the context of an online competition designed to challenge sexual minority women stereotypes and increase visibility. To increase the believability of the normative statistics, players create a social media-inspired profile at registration which includes an optional photo, brief bio, links to social media accounts, and other basic information. Registered players are able to browse the profiles of others and actual norms for all topics are transparently generated by the responses of players taking part in the competition. To increase motivation and engagement, each monthly round of the competition features a point-based reward system, a leader board, and a cash prize that is awarded to the top scorer who demonstrates the greatest accuracy in perceptions of peers. To decrease defensive reactions and increase appeal, feedback topics are ostensibly selected by chance in the game with treatment PNF on alcohol use and stigma-coping behaviors delivered alongside feedback on control topics of high interest to community members (e.g., style, relationships, sex, etc.). Appeal and credibility are also gained through sponsorship and promotion of the competition by several collaborating community organizations trusted as sources for health and social information by sexual minority women.
One round of the game is played each month over a 8 month period. Players are encouraged to browse player profiles before each round and it is made clear that the goal is to grow one's score by submitting accurate guesses and strategic bets on the responses of other players in one's age and sexual identity group. Each round includes questions about 2 to 3 topics ostensibly selected by a slot machine like spinner. For each topic, players make guesses about the behaviors and experiences of other players in their age and sexual identity group, choose amounts of points to bet on these guesses being true of the group, and then contribute to actual group norms by answering parallel questions. Each round is "open" for 30 days. Once closed, players are sent a text message containing a private link at which they can see detailed results (PNF) for the round, view the leaderboard and cash prize winner, and play the next round.
Packaging this intervention as a fun, identity-relevant competition for sexual minority women rather than a transparent alcohol intervention study allows feasibility and efficacy to be evaluated simultaneously, with a high degree of ecological validity. First, 1200 sexual minority women will be recruited to take part in the online competition. No participation-based incentives will be offered to players beyond the opportunity to compete for a variable cash prize each round. Then, following two initial rounds of play, a sub-sample of 500 drinkers will be invited to take part in an incentivized evaluation study after answering alcohol use questions in Round 3. Upon consenting to participate in the evaluation study, participants will be randomized to receive 1 of 3 unique sequences of feedback (i.e., Alcohol \& Stigma-Coping, Alcohol \& Control, or Control only) during intervention Rounds 3 and 4. Short-term reductions in alcohol use will be assessed in Round 6 of the competition where players will be prompted to guess, bet on, and answer alcohol use and control topic questions for a second time (i.e., Replay Bonus Round; 2 month follow-up). Following all rounds of the competition, a short survey will assess the alcohol use and negative consequences of Evaluation Study participants a final time (4 month follow-up).
Feasibility analysis will examine engagement with the online competition platform and sustainability of play in the absence of traditional study participation incentives among players not involved in the Evaluation Study. Efficacy analysis will focus on study participants randomly assigned to 1 of the 3 feedback conditions in order to: 1) evaluate whether PNF on alcohol use reduces sexual minority women's alcohol consumption and negative consequences relative to PNF on control topics; 2) examine whether providing PNF on stigma-coping behaviors in addition to alcohol use further reduces alcohol use and consequences beyond alcohol PNF; and, 3) identify mediators and moderators of intervention effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The web app is programmed to invite an eligible sub-sample of participants from the larger population to take part in an evaluation study during the competition's 3rd monthly round. Those who consent to participate are automatically randomized by Qualtrics Research Suite to receive 1 of 3 unique sequences of feedback (i.e., Alcohol \& Stigma-Coping, Alcohol \& Control, or Control topics only) during 2 intervention rounds taking place during a 6-month period.
| Arm | Type | Receives |
|---|---|---|
| Alcohol + Stigma Coping PNF | Experimental | Behavioral: Personalized Normative FeedbackParticipants randomized to this condition will receive gamified personalized normative feedback on their alcohol use after answering questions about alcohol use and two control topics in Round 3. Then, in the very next Round of the competition (Round 4), these participants will receive gamified personalized normative feedback on their stigma coping behaviors after answering questions about their stigma coping behaviors and two control topics. |
| Alcohol + Control PNF | Experimental | Behavioral: Personalized Normative FeedbackParticipants randomized to this condition will receive gamified personalized normative feedback on their alcohol use after answering questions about alcohol use and control topics in Round 3. Then, in the very next Round of the competition (Round 4), these participants will receive gamified personalized normative feedback on one control topic (Relationships) after answering questions about their stigma coping behaviors and two control topics. |
| Control PNF | Other | Behavioral: Personalized Normative FeedbackParticipants randomized to the control arm will answer questions about the same topics as participants in the other conditions in Round 3 (Alcohol Use \& Control) and Round 4 (Stigma-Coping \& Control). However, in both Rounds 3 and 4 they will receive gamified PNF on control topics. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Registered for the online competition
- Accept the competition's Terms of Service \& Privacy Policy
- Endorses a lesbian, bisexual, or queer female sexual identity
- Is between the ages of 21 and 55 years
- Has consumed 3 or more drinks on at least one occasion during the previous 2 months OR consumes alcohol 3 or more days per week
Key exclusion criteria (8 listed)
- Does not register for the online competition.
- Does not accept the competition's Terms of Service \& Privacy Policy
- Is younger than 21 years of age or older than 55 years of age.
- Has NOT consumed 3 or more drinks on at least one occasion during the previous 2 months AND drinks less than 3 days per week
- Lives outside of North America
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 |
|---|---|---|
| Personalized Normative FeedbackPersonalized Normative Feedback (PNF) is a popular social norms-based intervention strategy which presents individuals with a personalized, individual report designed to correct misperceived peer norms using a graphical display. Bar charts compare actual alcohol use statistics for the peer group to A) participants' estimates of peer drinking and, B) their own self-reported drinking. | Behavioural | Alcohol + Control PNF, Alcohol + Stigma Coping PNF, Control PNF |
Primary outcome
Change in Number of Drinks Per Week From Baseline to the the 2 Month Follow-up
Time frame: 2 months
At baseline and the 2 month follow-up, items assessing drinking days per week and average drinks per occasion were multiplied in order to compute number of drinks per week. These items come from the Frequency, Quantity, Max (FQM) measure. [Baer J, S. Etiology and secondary prevention of alcohol problems with young adults. Baer J S, Marlatt G A, McMahon R, J, editors. Newbury Park: Sage; 1993.] To compute the outcome, the 2 month measure of drinks per week was subtracted from the baseline measure of drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change in Number of Drinks Per Week From Baseline to the 4 Month Follow-up
Time frame: 4 months
At baseline and the 4 month follow-up, items assessing drinking days per week and average drinks per occasion were multiplied in order to compute number of drinks per week. These items come from the Frequency, Quantity, Max (FQM) measure. [Baer J, S. Etiology and secondary prevention of alcohol problems with young adults. Baer J S, Marlatt G A, McMahon R, J, editors. Newbury Park: Sage; 1993.] To compute the outcome, the 4 month measure of drinks per week was subtracted from the baseline measure of drinks per week such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change in Peak Drinks on One Occasion From Baseline to the 2 Months Follow-up
Time frame: 2 months
At baseline and the 2 month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. [Baer J, S. Etiology and secondary prevention of alcohol problems with young adults. Baer J S, Marlatt G A, McMahon R, J, editors. Newbury Park: Sage; 1993.] To compute the outcome, the 2 month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change in Peak Drinks on One Occasion From Baseline to the 4 Month Follow-up
Time frame: 4 months
At baseline and the 4 month follow-up, an item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure was used to assess peak drinks on one occasion over the past 30 days. [Baer J, S. Etiology and secondary prevention of alcohol problems with young adults. Baer J S, Marlatt G A, McMahon R, J, editors. Newbury Park: Sage; 1993.] To compute the outcome, the 4 month measure of peak drinks was subtracted from the baseline measure of peak drinks such that a positive value indicates a decrease in consumption during this period and a negative value indicates an increase in consumption during this period.
Change in Number of Negative Alcohol-related Consequences From Baseline to the 2 Month Follow-up
Time frame: 2 months
At baseline and the 2 month follow-up, a single item assessed the number of negative alcohol-related consequences experienced out of a list of 8 common negative alcohol-related consequences. This item is adapted from Riley BB, Hughes TL, Wilsnack SC. Validating a hazardous drinking index in a sample of sexual minority women: Reliability, validity, and predictive accuracy. Substance Use and Misuse. 2017;52(1):43-51. doi: 10.1080/10826084.2016.1214150.] To compute the outcome, the 2 month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Change in Number of Negative Alcohol-related Consequences From Baseline to the 4 Month Follow-up
Time frame: 4 months
At baseline and the 4 month follow-up, a single item assessed the number of negative alcohol-related consequences experienced out of a list of 8 common negative alcohol-related consequences. This item is adapted from Riley BB, Hughes TL, Wilsnack SC. Validating a hazardous drinking index in a sample of sexual minority women: Reliability, validity, and predictive accuracy. Substance Use and Misuse. 2017;52(1):43-51. doi: 10.1080/10826084.2016.1214150.] To compute the outcome, the 4 month measure of negative consequences was subtracted from the baseline measure of negative consequences such that a positive value indicates a decrease in consequences during this period and a negative value indicates an increase in consequences during this period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33861212Boyle SC, LaBrie JW. A Gamified, Social Media-Inspired, Web-Based Personalized Normative Feedback Alcohol Intervention for Lesbian, Bisexual, and Queer-Identified Women: Protocol for a Hybrid Trial. JMIR Res Protoc. 2021 Apr 16;10(4):e24647. doi: 10.2196/24647.
- Derived from this study: PubMed 35559854Boyle SC, LaBrie JW, Trager BM, Costine LD. A Gamified Personalized Normative Feedback App to Reduce Drinking Among Sexual Minority Women: Randomized Controlled Trial and Feasibility Study. J Med Internet Res. 2022 May 13;24(5):e34853. doi: 10.2196/34853.
- Individual participant dataSharing planned: Yes. A de-identified longitudinal dataset containing data from Evaluation Study participants at will be made available to researchers 1 year after the initial publication of results. This data set will include participant demographics and outcome measures assessed at baseline (Round 3), the 2 month follow-up (Round 6), and the 4 month follow-up (a survey following the last round of the competition). A data dictionary will be provided.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Normative Feedback in people with Alcohol Drinking and Alcohol Abuse, run by Loyola Marymount University at 1 site in United States.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 7 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Drinks Per Week From Baseline to the the 2 Month Follow-up (time frame: 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03884478, which also lists 2 linked publications.
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 7 Mar 2023.