DRT Mobile Intervention to Increase Safe Drinking

Alcohol; Use, Problem Clinical Trial

Official title:

An Adaptive Mobile Intervention to Increase Safe Drinking Strategies Using Deviance Regulation Theory

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05098639
• Other study ID #: STUDY00001422
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 3, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current project uses a brief mobile intervention, grounded in Deviance Regulation Theory, to deliver in-the-moment messaging meant to increase responsible drinking among college students. Participants receive positive messages about individuals that use responsible drinking behaviors or negative messages about individuals that do not use responsible drinking behaviors. It is hypothesized that these messages delivered at appropriate times will differentially affect use of responsible drinking behaviors as a function of individual beliefs about the prevalence of responsible drinking among peers.

Description:

College student alcohol use remains a significant public health issue. College students consume alcohol at higher rates than their non-college peers. Though most college students "mature out" of heavy alcohol use by graduation, the consequences resulting from frequent acute intoxication during college can be devastating. Identifying cost effective ways to reduce problematic alcohol use, that can be widely disseminated, remains vitally important. A large body of literature has examined associations between social norms and drinking among college students. Several college drinking interventions have utilized social norms to reduce alcohol use and alcohol-related consequences. However, recent research suggests these interventions may not be as effective as once though. Despite the support for social norms as an etiological basis for heavy drinking, and its implementation in interventions, the operationalization has remained relatively narrow. Social norms interventions have generally not taken broader theoretical perspectives into account. Nor have they been applied much beyond the exclusive focus on quantity and frequency of consumption. The present study addresses these issues by examining the effects of an intervention grounded in Deviance Regulation Theory, meant to increase use of alcohol protective behavioral strategies when drinking. Deviance Regulation Theory posits that individuals will seek to engage in behaviors that allow them to standout in positive ways or avoid standing-out in negative ways. Both of these effects are based on the perception of the behavioral norm. Participants are randomly assigned to receive messages that presents individuals who DO use PBS in a positive light, information that presents individuals who DO NOT use PBS in a negative light, or an active control (BASICS). It is hypothesized that among individuals who believe PBS use is uncommon among their peers, positive messages about PBS users will result in increased PBS use, and subsequent decreases in alcohol use and problems. In contrast among individuals who believe PBS use is common among their peers, negative messages about PBS users will result in increased PBS use, and subsequent decreases in alcohol use and alcohol problems. If successful this trial will pave the way for a novel intervention for college students that can be tailored to individual beliefs about PBS use norms and that could be combined with existing interventions for college student drinking.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• Severe mental illness

• Under 18 years of age

• Over 26 years of age

• Unable to speak English fluently

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol; Use, Problem

Intervention

Behavioral:
• BASICS
In the BASICS condition, individuals receive information about alcohol use on campus and discuss safe drinking practices. They also receive personalized normative feedback based on their alcohol use and their use of protective behavioral strategies.
• Deviance Regulation Theory (DRT)
The Deviance Regulation Intervention comprises tailored intervention messages based on perceived norms. Participants complete an initial session that focuses on perceived norms of protective behavioral strategy (PBS) use and heavy drinking among peers. The therapist engages participants in a tailored discussion based on their perceived norms. If individuals believe PBS use is uncommon, the therapist discusses the positive social image that PBS use portrays. If the participant believes PBS is common, the therapist engages the participant in discussion of the negative aspects of non-PBS use. A similar strategy is taken for common and uncommon heavy alcohol use. Finally, the participant carries a mobile device which provide real-time adaptive positive or negative messages (consistent with the initial session) based on the perceived drinking and PBS norms of their current drinking environment.

Locations

Country	Name	City	State
United States	The University of Central Florida	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protective Behavioral Strategies- Pre-Intervention	Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past three months. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.	Past three months prior to intervention/study
Primary	Protective Behavioral Strategies- Initial intervention (Week 1)	Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.	Past week before intervention
Primary	Protective Behavioral Strategies- Week 2	Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.	Past 1 week measured- 1 week post intervention
Primary	Protective Behavioral Strategies- Week 3	Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.	Past 1 week measured-2 weeks post intervention
Primary	Protective Behavioral Strategies- Week 4	Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.	Past 1 week measured-3 weeks post intervention
Primary	Protective Behavioral Strategies- 3 month follow up	Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past three months. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.	Past 3 months measured- 12 week post intervention
Primary	Protective Behavioral Strategies- 6 month follow-up	Protective behavioral strategies (PBS) are harm-reduction strategies to decrease alcohol-related consequences when consuming alcohol. There are three subtypes: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times). PBS are assessed in this study using the Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use will be reported on a five-point Likert-scale from 0 (Never) to 4 (Always). The mean score across all 20 items serves as the outcome variable. Participants are asked to record their PBS use from the past three months. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.	Past 3 months measured- 26 weeks post intervention
Secondary	Alcohol-related consequences- Pre-intervention	Alcohol-related consequences are assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants record alcohol consequences (Yes/No/ I do not wish to respond) from the past three months. Scores can range from 0-48. Higher scores indicate a greater number of alcohol consequences.	Past three months prior to intervention/study
Secondary	Alcohol-related consequences- Initial intervention (Week 1)	Alcohol-related consequences are assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants record alcohol consequences (Yes/No/ I do not wish to respond) from the past week. Scores can range from 0-48. Higher scores indicate a greater number of alcohol consequences.	Past week before intervention
Secondary	Alcohol-related consequences- Week 2	Alcohol-related consequences are assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants record alcohol consequences (Yes/No/ I do not wish to respond) from the past week. Scores can range from 0-48. Higher scores indicate a greater number of alcohol consequences.	Past 1 week measured- 1 week post intervention
Secondary	Alcohol-related consequences- Week 3	Alcohol-related consequences are assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants record alcohol consequences (Yes/No/ I do not wish to respond) from the past week. Scores can range from 0-48. Higher scores indicate a greater number of alcohol consequences.	Past 1 week measured- 2 week post intervention
Secondary	Alcohol-related consequences- Week 4	Alcohol-related consequences are assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants record alcohol consequences (Yes/No/ I do not wish to respond) from the past week. Scores can range from 0-48. Higher scores indicate a greater number of alcohol consequences.	Past 1 week measured- 3 week post intervention
Secondary	Alcohol-related consequences- 3 month follow up	Alcohol-related consequences are assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants record alcohol consequences (Yes/No/ I do not wish to respond) from the past week. Scores can range from 0-48. Higher scores indicate a greater number of alcohol consequences.	Past 3 months measured- 12 week post intervention
Secondary	Alcohol-related consequences- 6 month follow-up	Alcohol-related consequences are assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants record alcohol consequences (Yes/No/ I do not wish to respond) from the past three months. Scores can range from 0-48. Higher scores indicate a greater number of alcohol consequences.	Past 3 months measured- 26 weeks post intervention
Secondary	Alcohol use- Pre-intervention	Alcohol use (quantity) is assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M uses a grid to report typical number of drinks consumed for an average day in an average week, over the last three months. The DDQ-M is used to measure the number of drinks consumed for each day of the week. These are summed across the days of the week to provide a measure of typical standard drinks consumed. The lower limit is 0, there is no upper limit as this is a self-reported number. Higher numbers indicate more alcohol is consumed.	Past three months prior to intervention/study
Secondary	Alcohol use- Initial intervention (Week 1)	Alcohol use (quantity) is assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M uses a grid to report typical number of drinks consumed for an average day in an average week, over the last week. The DDQ-M is used to measure the number of drinks consumed for each day of the last week. These are summed across the days of the week to provide a measure of standard drinks consumed for the previous week. The lower limit is 0, there is no upper limit as this is a self-reported number. Higher numbers indicate more alcohol is consumed.	Past week before intervention
Secondary	Alcohol use- Week 2	Alcohol use (quantity) is assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M uses a grid to report typical number of drinks consumed for an average day in an average week, over the last week. The DDQ-M is used to measure the number of drinks consumed for each day of the last week. These are summed across the days of the week to provide a measure of standard drinks consumed for the previous week. The lower limit is 0, there is no upper limit as this is a self-reported number. Higher numbers indicate more alcohol is consumed.	Past 1 week measured- 1 week post intervention
Secondary	Alcohol use- Week 3	Alcohol use (quantity) is assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M uses a grid to report typical number of drinks consumed for an average day in an average week, over the last week. The DDQ-M is used to measure the number of drinks consumed for each day of the last week. These are summed across the days of the week to provide a measure of standard drinks consumed for the previous week. The lower limit is 0, there is no upper limit as this is a self-reported number. Higher numbers indicate more alcohol is consumed.	Past 1 week measured- 2 weeks post intervention
Secondary	Alcohol use- Week 4	Alcohol use (quantity) is assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M uses a grid to report typical number of drinks consumed for an average day in an average week, over the last week. The DDQ-M is used to measure the number of drinks consumed for each day of the last week. These are summed across the days of the week to provide a measure of standard drinks consumed for the previous week. The lower limit is 0, there is no upper limit as this is a self-reported number. Higher numbers indicate more alcohol is consumed.	Past 1 week measured- 3 weeks post intervention
Secondary	Alcohol use- 3 month follow up	Alcohol use (quantity) is assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M uses a grid to report typical number of drinks consumed for an average day in an average week, over the last three months. The DDQ-M is used to measure the number of drinks consumed for each day of the week. These are summed across the days of the week to provide a measure of typical standard drinks consumed. The lower limit is 0, there is no upper limit as this is a self-reported number. Higher numbers indicate more alcohol is consumed.	Past 3 months measured- 12 week post intervention
Secondary	Alcohol use- 6 month follow up	Alcohol use (quantity) is assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M uses a grid to report typical number of drinks consumed for an average day in an average week, over the last three months. The DDQ-M is used to measure the number of drinks consumed for each day of the week. These are summed across the days of the week to provide a measure of typical standard drinks consumed. The lower limit is 0, there is no upper limit as this is a self-reported number. Higher numbers indicate more alcohol is consumed.	Past 3 months measured- 24 week post intervention