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

NCT03884478 | Completed Results

• 1 other identifier: 1R21AA025767-01A1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Alcohol Drinking; Alcohol Abuse; Alcohol; Harmful Use

Keywords

Social Norms; Personalized Normative Feedback; Sexual Minority Women

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  4 months

Study Arms (3)

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.

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.

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.

Behavioral: Personalized Normative Feedback

Interventions

Personalized Normative Feedback BEHAVIORAL

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.

Alcohol + Control PNF; Alcohol + Stigma Coping PNF; Control PNF

Eligibility Criteria

• Age: 21 Years - 55 Years
• Gender Eligibility Details: Participants must endorse a lesbian, bisexual, or queer female sexual identity. Both the larger competition and the Evaluation Study are trans-inclusive. That is, individuals who endorse one of these sexual minority identities and presently endorse a female gender identity (regardless of whether their birth sex is female) may take part in the competition and the Evaluation Study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola Marymount University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Loyola Marymount University

Los Angeles, California, 90045, United States

Location

Related Publications (2)

• 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.

  PMID: 33861212 BACKGROUND

• 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.

  PMID: 35559854 DERIVED

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

No limitations. However, in hindsight it would have been ideal to have included an assessment only control arm, which would have allowed us to evaluate app use effects beyond the PNF received.

Results Point of Contact

• Title: Dr. Sarah C. Boyle, Senior Research Scientist
• Organization: Loyola Marymount University

sarah.boyle@lmu.edu

3105686681

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 21, 2019
• Study Start: February 6, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year following the publication of results.
• Access Criteria: The Office of Sponsored Research at Loyola Marymount University is currently working with the University's IT department to develop a data repository for the purpose of data and resource sharing. Study materials and data will be made available to the public on a secure web portal.

Locations

US (1)