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A Gamified, Social Media Inspired Personalized Normative Feedback Alcohol Intervention for Sexual Minority Women

PNF 2.0: A Novel, Gamified, Facebook-Integrated Personalized Normative Feedback Intervention to Reduce Alcohol Use and Negative Consequences Among Sexual Minority Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03884478
Enrollment
500
Registered
2019-03-21
Start date
2019-02-06
Completion date
2019-10-10
Last updated
2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse, Alcohol Drinking, Alcohol; Harmful Use

Keywords

Social Norms, Personalized Normative Feedback, Sexual Minority Women

Brief 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 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.

Interventions

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.

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH
Loyola Marymount University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Number of Drinks Per Week From Baseline to the the 2 Month Follow-up2 monthsAt 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-up4 monthsAt 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-up2 monthsAt 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-up4 monthsAt 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-up2 monthsAt 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-up4 monthsAt 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

The 3rd round of LezParlay served as both the screening instrument and baseline assessment for the clinical trial. A total of 1337 women completed the round with the first 912 screened for clinical trial eligibility before the 500 spots in the trial were filled. One enrolled participant randomized to an arm was withdrawn prior to intervention delivery after disclosing to the research team that she had lied about her age and was actually a minor. This resulted in an N of 499.

Participants by arm

ArmCount
Alcohol + Stigma Coping PNF
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. 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.
143
Alcohol + Control PNF
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. 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.
179
Control PNF
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. 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.
177
Total499

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Baseline to 2 Months Post-interventionLost to Follow-up303336
Baseline to 2 Months Post-interventionWithdrawn by research team100
Baseline to 4 Months Post-interventionLost to Follow-up425051
Baseline to 4 Months Post-interventionWithdrawn by research team100

Baseline characteristics

CharacteristicTotalControl PNFAlcohol + Control PNFAlcohol + Stigma Coping PNF
Age, Continuous29.87 years
STANDARD_DEVIATION 7.32
29.47 years
STANDARD_DEVIATION 7.03
30.37 years
STANDARD_DEVIATION 7.75
29.73 years
STANDARD_DEVIATION 7.15
Ethnicity (NIH/OMB)
Hispanic or Latino
123 Participants40 Participants46 Participants37 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
376 Participants137 Participants133 Participants106 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Interpersonal Sexual Minority Stigma Exposure.61 units on a scale (range 0 low to 2 high)
STANDARD_DEVIATION 0.69
.66 units on a scale (range 0 low to 2 high)
STANDARD_DEVIATION 0.69
.56 units on a scale (range 0 low to 2 high)
STANDARD_DEVIATION 0.66
.62 units on a scale (range 0 low to 2 high)
STANDARD_DEVIATION 0.7
Race (NIH/OMB)
American Indian or Alaska Native
13 Participants4 Participants5 Participants4 Participants
Race (NIH/OMB)
Asian
39 Participants17 Participants16 Participants6 Participants
Race (NIH/OMB)
Black or African American
70 Participants26 Participants25 Participants19 Participants
Race (NIH/OMB)
More than one race
107 Participants31 Participants41 Participants35 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
268 Participants99 Participants91 Participants78 Participants
Region of Enrollment
United States
499 participants177 participants179 participants143 participants
Sex: Female, Male
Female
499 Participants177 Participants179 Participants143 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants
Sexual Identity
Bisexual
116 Participants48 Participants39 Participants29 Participants
Sexual Identity
Lesbian
291 Participants94 Participants108 Participants89 Participants
Sexual Identity
Queer
92 Participants35 Participants32 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 1430 / 1790 / 177
other
Total, other adverse events
0 / 1430 / 1790 / 177
serious
Total, serious adverse events
0 / 1430 / 1790 / 177

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Alcohol + Stigma Coping PNFChange in Number of Drinks Per Week From Baseline to the 4 Month Follow-up2.52 alcoholic drinks per weekStandard Deviation 4.68
Alcohol + Control PNFChange in Number of Drinks Per Week From Baseline to the 4 Month Follow-up1.99 alcoholic drinks per weekStandard Deviation 4.57
Control PNFChange in Number of Drinks Per Week From Baseline to the 4 Month Follow-up0.52 alcoholic drinks per weekStandard Deviation 5.88
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.p-value: 0.025Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.p-value: 0.11Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.p-value: 0.66Mixed Models Analysis
Primary

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

ArmMeasureValue (MEAN)Dispersion
Alcohol + Stigma Coping PNFChange in Number of Drinks Per Week From Baseline to the the 2 Month Follow-up2.75 alcoholic drinks per weekStandard Deviation 4.3
Alcohol + Control PNFChange in Number of Drinks Per Week From Baseline to the the 2 Month Follow-up1.99 alcoholic drinks per weekStandard Deviation 4.57
Control PNFChange in Number of Drinks Per Week From Baseline to the the 2 Month Follow-up-.68 alcoholic drinks per weekStandard Deviation 5.49
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.p-value: 0.0001Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Control Arm\*T2 interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.p-value: 0.005Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol Only Arm.p-value: 0.25Mixed Models Analysis
Primary

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

ArmMeasureValue (MEAN)Dispersion
Alcohol + Stigma Coping PNFChange in Number of Negative Alcohol-related Consequences From Baseline to the 2 Month Follow-up.23 negative consequencesStandard Deviation 1.82
Alcohol + Control PNFChange in Number of Negative Alcohol-related Consequences From Baseline to the 2 Month Follow-up.25 negative consequencesStandard Deviation 1.56
Control PNFChange in Number of Negative Alcohol-related Consequences From Baseline to the 2 Month Follow-up-.76 negative consequencesStandard Deviation 1.68
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.p-value: <0.001Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.p-value: <0.001Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.p-value: 0.87Mixed Models Analysis
Primary

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

ArmMeasureValue (MEAN)Dispersion
Alcohol + Stigma Coping PNFChange in Number of Negative Alcohol-related Consequences From Baseline to the 4 Month Follow-up.34 negative consequencesStandard Deviation 1.55
Alcohol + Control PNFChange in Number of Negative Alcohol-related Consequences From Baseline to the 4 Month Follow-up.21 negative consequencesStandard Deviation 1.56
Control PNFChange in Number of Negative Alcohol-related Consequences From Baseline to the 4 Month Follow-up-.67 negative consequencesStandard Deviation 1.59
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.p-value: <0.001Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.p-value: 0.002Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on negative consequences. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in negative consequences from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.p-value: 0.43Mixed Models Analysis
Primary

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

ArmMeasureValue (MEAN)Dispersion
Alcohol + Stigma Coping PNFChange in Peak Drinks on One Occasion From Baseline to the 2 Months Follow-up1.49 alcoholic drinksStandard Deviation 1.78
Alcohol + Control PNFChange in Peak Drinks on One Occasion From Baseline to the 2 Months Follow-up1.42 alcoholic drinksStandard Deviation 1.86
Control PNFChange in Peak Drinks on One Occasion From Baseline to the 2 Months Follow-up-.18 alcoholic drinksStandard Deviation 1.92
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 2 month follow-up in the Alcohol+Coping Arm versus the Control Arm.p-value: <0.001Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Control Arm versus the Control Arm.p-value: <0.001Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks at the 2 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.p-value: 0.88Mixed Models Analysis
Primary

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

ArmMeasureValue (MEAN)Dispersion
Alcohol + Stigma Coping PNFChange in Peak Drinks on One Occasion From Baseline to the 4 Month Follow-up.82 alcoholic drinksStandard Deviation 1.71
Alcohol + Control PNFChange in Peak Drinks on One Occasion From Baseline to the 4 Month Follow-up.61 alcoholic drinksStandard Deviation 1.46
Control PNFChange in Peak Drinks on One Occasion From Baseline to the 4 Month Follow-up.08 alcoholic drinksStandard Deviation 2.06
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Control Arm.p-value: 0.03Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on peak drinks. To probe the significant Alcohol+Control Arm\*Time interaction, a Tukey post-hoc test examined the change in weekly drinks from baseline to the 4 month follow-up in the Alcohol+Control Arm versus the Control Arm.p-value: 0.059Mixed Models Analysis
Comparison: As detailed in the statistical analysis plan, a multi-level model which held constant participant age, race, ethnicity, relationship status, sexual identity, and sexual minority interpersonal stigma exposure in examining Time\*Arm interactions on weekly drinks. To probe the significant Alcohol+Coping Arm\*Time interaction, a Tukey post-hoc test examined the change in peak drinks from baseline to the 4 month follow-up in the Alcohol+Coping Arm versus the Alcohol+Control Arm.p-value: 0.71Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026