An interventional study of Personalized Normative Feedback in Alcohol Drinking, Alcohol Abuse and Alcohol; Harmful Use, sponsored by Loyola Marymount University. Completed at 1 site in United States. Open to female participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by Loyola Marymount University · Not applicable, Interventional, and Prevention
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).
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 500 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Loyola Marymount University is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Personalized Normative Feedback
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.
Behavioral: Personalized Normative Feedback
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.
Behavioral: Personalized Normative Feedback
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months
Players learned about the broader LezParlay competition through 1 of 4 promotion strategies taking place over a 3-month period (11/15/2018 thru 2/15/2019): 1) flyers and promotional items distributed at local LBQ community events in Los Angeles; 2) targeted advertisement campaigns on HER social app, the leading LBQ dating app; 3) an advertisement in the email newsletter of Autostraddle, a popular blog for LBQ women; 4) targeted advertisement campaigns on Google, Facebook, and Instagram.
| Milestone | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF |
|---|---|---|---|
| Started | 144 | 179 | 177 |
| Completed | 113 | 146 | 141 |
| Not completed | 31 | 33 | 36 |
| Withdrew: Lost to follow-up | 30 | 33 | 36 |
| Withdrew: Withdrawn by research team | 1 | 0 | 0 |
| Milestone | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF |
|---|---|---|---|
| Started | 144 | 179 | 177 |
| Completed | 101 | 129 | 126 |
| Not completed | 43 | 50 | 51 |
| Withdrew: Lost to follow-up | 42 | 50 | 51 |
| Withdrew: Withdrawn by research team | 1 | 0 | 0 |
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.
| alcoholic drinks per week | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF |
|---|---|---|---|
| Change in Number of Drinks Per Week From Baseline to the the 2 Month Follow-up | 2.75 ± 4.30 | 1.99 ± 4.57 | -.68 ± 5.49 |
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.
| alcoholic drinks per week | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF |
|---|---|---|---|
| Change in Number of Drinks Per Week From Baseline to the 4 Month Follow-up | 2.52 ± 4.68 | 1.99 ± 4.57 | 0.52 ± 5.88 |
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.
| alcoholic drinks | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF |
|---|---|---|---|
| Change in Peak Drinks on One Occasion From Baseline to the 2 Months Follow-up | 1.49 ± 1.78 | 1.42 ± 1.86 | -.18 ± 1.92 |
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.
| alcoholic drinks | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF |
|---|---|---|---|
| Change in Peak Drinks on One Occasion From Baseline to the 4 Month Follow-up | .82 ± 1.71 | .61 ± 1.46 | .08 ± 2.06 |
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.
| negative consequences | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF |
|---|---|---|---|
| Change in Number of Negative Alcohol-related Consequences From Baseline to the 2 Month Follow-up | .23 ± 1.82 | .25 ± 1.56 | -.76 ± 1.68 |
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.
| negative consequences | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF |
|---|---|---|---|
| Change in Number of Negative Alcohol-related Consequences From Baseline to the 4 Month Follow-up | .34 ± 1.55 | .21 ± 1.56 | -.67 ± 1.59 |
Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alcohol + Stigma Coping PNF | 0/143 (0%) | 0/143 (0%) | 0/143 (0%) |
| Alcohol + Control PNF | 0/179 (0%) | 0/179 (0%) | 0/179 (0%) |
| Control PNF | 0/177 (0%) | 0/177 (0%) | 0/177 (0%) |
1 participant randomized to the Alcohol + Stigma Coping PNF condition disclosed being a minor after study enrollment. This participant was was withdrawn from the study and their data was excluded from analysis
| Age, Continuous(years) | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF | Total |
|---|---|---|---|---|
| Mean | 29.73 ± 7.15 | 30.37 ± 7.75 | 29.47 ± 7.03 | 29.87 ± 7.32 |
| Sex: Female, Male(Participants) | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF | Total |
|---|---|---|---|---|
| Female | 143 | 179 | 177 | 499 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF | Total |
|---|---|---|---|---|
| Hispanic or Latino | 37 | 46 | 40 | 123 |
| Not Hispanic or Latino | 106 | 133 | 137 | 376 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 4 | 5 | 4 | 13 |
| Asian | 6 | 16 | 17 | 39 |
| Native Hawaiian or Other Pacific Islander | 1 | 1 | 0 | 2 |
| Black or African American | 19 | 25 | 26 | 70 |
| White | 78 | 91 | 99 | 268 |
| More than one race | 35 | 41 | 31 | 107 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF | Total |
|---|---|---|---|---|
| United States | 143 | 179 | 177 | 499 |
| Sexual Identity(Participants) | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF | Total |
|---|---|---|---|---|
| Lesbian | 89 | 108 | 94 | 291 |
| Bisexual | 29 | 39 | 48 | 116 |
| Queer | 25 | 32 | 35 | 92 |
| Interpersonal Sexual Minority Stigma Exposure(units on a scale (range 0 low to 2 high)) | Alcohol + Stigma Coping PNF | Alcohol + Control PNF | Control PNF | Total |
|---|---|---|---|---|
| Mean | .62 ± .70 | .56 ± .66 | .66 ± .69 | .61 ± .69 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Icf
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Loyola Marymount University