Clinical trial NCT03884478: A Gamified, Social Media Inspired Personalized Normative Feedback Alcohol Intervention for Sexual Minority Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Alcohol Abuse
Alcohol; Harmful Use
Keywords: Social Norms
Personalized Normative Feedback
Sexual Minority Women
Lead sponsor: Loyola Marymount University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-03-21
Enrollment: 500
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Number of Drinks Per Week From Baseline to the the 2 Month Follow-up
timeFrame: 2 months
measure: Change in Number of Drinks Per Week From Baseline to the 4 Month Follow-up
timeFrame: 4 months
measure: Change in Peak Drinks on One Occasion From Baseline to the 2 Months Follow-up
timeFrame: 2 months
measure: Change in Peak Drinks on One Occasion From Baseline to the 4 Month Follow-up
timeFrame: 4 months
measure: Change in Number of Negative Alcohol-related Consequences From Baseline to the 2 Month Follow-up
timeFrame: 2 months
measure: Change in Number of Negative Alcohol-related Consequences From Baseline to the 4 Month Follow-up
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Loyola Marymount University
state: California
Study officials:
References:
citation: 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.
citation: Boyle 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.