Alcohol; Use, ProblemNCT05098639
DRT Mobile Intervention to Increase Safe Drinking
A study testing BASICS and Deviance Regulation Theory (DRT) in people with Alcohol; Use, Problem, run by University of Central Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol; Use, Problem
- What is being tested?
- BASICS and Deviance Regulation Theory (DRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- Severe mental illness
- Under 18 years of age
- Over 26 years of age
- Unable to speak English fluently
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Central Florida
Orlando, Florida, 32816
About this study
Official title: An Adaptive Mobile Intervention to Increase Safe Drinking Strategies Using Deviance Regulation Theory
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.
Read the detailed 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.
- Conditions
- Alcohol; Use, Problem
- Being tested
- BASICS, Deviance Regulation Theory (DRT)
- Keywords
- Alcohol Use, Deviance Regulation Theory, Mobile Intervention, Protective Behavioral Strategies
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASICSBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BASICS | Active comparator | Participants in the active control will receive a modified single session BASICS. BASICS is a well-documented and empirically supported prevention/intervention program for college student drinkers. BASICS targets heavy drinking students that have experienced or are at an increased risk for a variety of alcohol-related problems linked to college student life. The program is designed to help students make better alcohol-use decisions based on a broader understanding of the risks associated with problem drinking. It enhances motivation to change and promotes the development of skills to moderate drinking. The overall style of the program uses motivational interviewing and emphasizes empathy and non-judgmental interaction. The aims of BASICS are to (1) reduce alcohol consumption and consequences, (2) promote healthier and more responsible choices, and (3) provide information and coping skills. Receives: Behavioral: BASICS |
| Deviance Regulation Theory | Experimental | DRT participants receive an initial intervention session that is consistent with their current (pre-intervention) PBS frequency norm beliefs. For the initial intervention session, participants discuss their perception of the use of alcohol and use of protective behavioral strategies among campus peers. They are given feedback on the injunctive norms of alcohol use and PBS use by their peers which is tailored to each individuals normative perceptions. Following the initial intervention session, participants will carry a mobile device that allows for individuals to report current drinking environments. They then receive DRT consistent feedback based on the norms reported in their current drinking environment. Receives: Behavioral: Deviance Regulation Theory (DRT) |
| Deviance Regulation Theory+BASICS | Experimental | DRT participants receive an initial intervention session that is consistent with their current (pre-intervention) PBS frequency norm beliefs but also follows the framework of BASICS. For the initial intervention session, participants discuss their perception of the use of alcohol and use of protective behavioral strategies among campus peers. They are given feedback on both descriptive and injunctive norms of alcohol use and PBS use by their peers which is tailored to each individuals normative perceptions. Following the initial intervention session, participants will carry a mobile device that allows for individuals to report current drinking environments. They then receive DRT consistent feedback based on the norms reported in their current drinking environment. Receives: Behavioral: BASICS; Behavioral: Deviance Regulation Theory (DRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Past three months prior to intervention/study
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.
Measured: Past week before intervention
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.
Measured: Past 1 week measured- 1 week post intervention
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.
Measured: Past 1 week measured-2 weeks post intervention
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.
Measured: Past 1 week measured-3 weeks post intervention
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.
Measured: Past 3 months measured- 12 week post intervention
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.
Measured: Past 3 months measured- 26 weeks post intervention
Secondary outcomes (14)
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.
Measured: Past three months prior to intervention/study
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.
Measured: Past week before intervention
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.
Measured: Past 1 week measured- 1 week post intervention
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.
Measured: Past 1 week measured- 2 week post intervention
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.
Measured: Past 1 week measured- 3 week post intervention
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.
Measured: Past 3 months measured- 12 week post intervention
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.
Measured: Past 3 months measured- 26 weeks post intervention
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.
Measured: Past three months prior to intervention/study
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.
Measured: Past week before intervention
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.
Measured: Past 1 week measured- 1 week post intervention
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.
Measured: Past 1 week measured- 2 weeks post intervention
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.
Measured: Past 1 week measured- 3 weeks post intervention
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.
Measured: Past 3 months measured- 12 week post intervention
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.
Measured: Past 3 months measured- 24 week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start3 Mar 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol; Use, ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will randomly assign participants to one of three conditions: Active Control (BASICS), DRT, or DRT+Active Control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098639
- Sponsor's protocol ID
- STUDY00001422
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2021
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be uploaded to the OSF page for this study
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Mobile Intervention to Increase Safe Drinking Strategies Using Deviance Regulation Theory
- ClinicalTrials.gov ID
- NCT05098639
- Acronym / sponsor ID
- STUDY00001422
- Conditions
- Alcohol; Use, Problem
- Keywords
- Alcohol Use, Deviance Regulation Theory, Mobile Intervention, Protective Behavioral Strategies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study will randomly assign participants to one of three conditions: Active Control (BASICS), DRT, or DRT+Active Control
| Arm | Type | Receives |
|---|---|---|
| BASICS | Active comparator | Behavioral: BASICSParticipants in the active control will receive a modified single session BASICS. BASICS is a well-documented and empirically supported prevention/intervention program for college student drinkers. BASICS targets heavy drinking students that have experienced or are at an increased risk for a variety of alcohol-related problems linked to college student life. The program is designed to help students make better alcohol-use decisions based on a broader understanding of the risks associated with problem drinking. It enhances motivation to change and promotes the development of skills to moderate drinking. The overall style of the program uses motivational interviewing and emphasizes empathy and non-judgmental interaction. The aims of BASICS are to (1) reduce alcohol consumption and consequences, (2) promote healthier and more responsible choices, and (3) provide information and coping skills. |
| Deviance Regulation Theory | Experimental | Behavioral: Deviance Regulation Theory (DRT)DRT participants receive an initial intervention session that is consistent with their current (pre-intervention) PBS frequency norm beliefs. For the initial intervention session, participants discuss their perception of the use of alcohol and use of protective behavioral strategies among campus peers. They are given feedback on the injunctive norms of alcohol use and PBS use by their peers which is tailored to each individuals normative perceptions. Following the initial intervention session, participants will carry a mobile device that allows for individuals to report current drinking environments. They then receive DRT consistent feedback based on the norms reported in their current drinking environment. |
| Deviance Regulation Theory+BASICS | Experimental | Behavioral: BASICS, Behavioral: Deviance Regulation Theory (DRT)DRT participants receive an initial intervention session that is consistent with their current (pre-intervention) PBS frequency norm beliefs but also follows the framework of BASICS. For the initial intervention session, participants discuss their perception of the use of alcohol and use of protective behavioral strategies among campus peers. They are given feedback on both descriptive and injunctive norms of alcohol use and PBS use by their peers which is tailored to each individuals normative perceptions. Following the initial intervention session, participants will carry a mobile device that allows for individuals to report current drinking environments. They then receive DRT consistent feedback based on the norms reported in their current drinking environment. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (4 listed)
- Severe mental illness
- Under 18 years of age
- Over 26 years of age
- Unable to speak English fluently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BASICSIn 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. | Behavioural | BASICS, Deviance Regulation Theory+BASICS |
| 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. | Behavioural | Deviance Regulation Theory, Deviance Regulation Theory+BASICS |
Primary outcome
Protective Behavioral Strategies- Pre-Intervention
Time frame: Past three months prior to intervention/study
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.
Protective Behavioral Strategies- Initial intervention (Week 1)
Time frame: Past week before 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 week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.
Protective Behavioral Strategies- Week 2
Time frame: Past 1 week measured- 1 week post 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 week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.
Protective Behavioral Strategies- Week 3
Time frame: Past 1 week measured-2 weeks post 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 week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.
Protective Behavioral Strategies- Week 4
Time frame: Past 1 week measured-3 weeks post 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 week. Scores range from 0 to 20. Higher scores indicate greater use of protective strategies.
Protective Behavioral Strategies- 3 month follow up
Time frame: Past 3 months measured- 12 week post 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.
Protective Behavioral Strategies- 6 month follow-up
Time frame: Past 3 months measured- 26 weeks post 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.
14 secondary outcomes
Alcohol-related consequences- Pre-intervention
Time frame: Past three months prior to intervention/study
Alcohol-related consequences- Initial intervention (Week 1)
Time frame: Past week before intervention
Alcohol-related consequences- Week 2
Time frame: Past 1 week measured- 1 week post intervention
Alcohol-related consequences- Week 3
Time frame: Past 1 week measured- 2 week post intervention
Alcohol-related consequences- Week 4
Time frame: Past 1 week measured- 3 week post intervention
Alcohol-related consequences- 3 month follow up
Time frame: Past 3 months measured- 12 week post intervention
Alcohol-related consequences- 6 month follow-up
Time frame: Past 3 months measured- 26 weeks post intervention
Alcohol use- Pre-intervention
Time frame: Past three months prior to intervention/study
Alcohol use- Initial intervention (Week 1)
Time frame: Past week before intervention
Alcohol use- Week 2
Time frame: Past 1 week measured- 1 week post intervention
Alcohol use- Week 3
Time frame: Past 1 week measured- 2 weeks post intervention
Alcohol use- Week 4
Time frame: Past 1 week measured- 3 weeks post intervention
Alcohol use- 3 month follow up
Time frame: Past 3 months measured- 12 week post intervention
Alcohol use- 6 month follow up
Time frame: Past 3 months measured- 24 week post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: Yes. All data will be uploaded to the OSF page for this study
Related trials for Alcohol; Use, Problem
Recruiting
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Alcohol Abuse, Alcohol Use Disorder
Recruiting
Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms
Postpartum Depression (PPD), Alcohol Use
Active, not recruiting
Evaluation of Effectiveness of the LifeSkills Training - Lombardia - Primary Shool Program ( Val3P-LST )
Well Being, Drug Addiction
Recruiting
tAN for Substance Use Disorder
Alcohol Use Disorder, Alcohol Abuse
Recruiting
Greek Connections Study
Heavy Episodic Drinking, Problem Drinking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BASICS and Deviance Regulation Theory (DRT) in people with Alcohol; Use, Problem, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protective Behavioral Strategies- Pre-Intervention (time frame: Past three months prior to intervention/study). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.