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

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ClinicalTrials.gov Identifier: NCT03884478
Recruitment Status : Completed
First Posted : March 21, 2019
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Loyola Marymount University

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).

Condition or disease Intervention/treatment Phase
Alcohol Drinking Alcohol Abuse Alcohol; Harmful Use Behavioral: Personalized Normative Feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : February 6, 2019
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ethanol

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: 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.
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.

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.
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.




Primary Outcome Measures :
  1. Change in number of drinks per week from baseline [ Time Frame: 2 months ]
    Items assessing drinking days per week and average drinks per occasion will be 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.]

  2. Change in number of drinks per week from baseline [ Time Frame: 4 months ]
    Items assessing drinking days per week and average drinks per occasion will be 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.]

  3. Change in peak drinks on one occasion from baseline [ Time Frame: 2 months ]
    The item assessing the number of maximum drinks on one occasion from the Frequency, Quantity, Max (FQM) measure is used. [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.]

  4. Change in peak drinks on one occasion from baseline [ Time Frame: 4 months ]
    The item assessing the maximum number of drinks consumed on one occasion from the Frequency, Quantity, Max (FQM) measure is used. [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.]

  5. Change in number of negative alcohol-related consequences from baseline [ Time Frame: 2 months ]
    A single item assessing the number of negative 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.]

  6. Change in number of negative alcohol-related consequences from baseline [ Time Frame: 4 months ]
    A single item assessing the number of negative 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.]



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884478


Locations
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United States, California
Loyola Marymount University
Los Angeles, California, United States, 90045
Sponsors and Collaborators
Loyola Marymount University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Responsible Party: Loyola Marymount University
ClinicalTrials.gov Identifier: NCT03884478    
Other Study ID Numbers: 1R21AA025767-01A1 ( U.S. NIH Grant/Contract )
1R21AA025767-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Loyola Marymount University:
Social Norms
Personalized Normative Feedback
Sexual Minority Women
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior