Longitudinal Use of Protective Behavioral Strategies

This study tested a deviance regulation theory intervention in a sample of university freshman. The aims were to (a) increase use of protective behavioral strategies, (b) decrease alcohol use, and (c) decrease alcohol-related consequences.

Study Overview

• Status: Completed
• Conditions: Alcohol Use, Unspecified
• Intervention / Treatment: Behavioral: Deviance Regulation Theory

Detailed Description

College student freshmen were invited to participate in a study on the use of alcohol protective behavioral strategies. They were randomly assigned to receive a positive message about individuals that used protective strategies, a negative message about individuals that did not use protective strategies, or an assessment control. They were then followed for the next 12 months. Assessments were completed at weeks 0, 1, 2, 3, 4, 5, 12, 26, and 52.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816-0001
      • The University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 21 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• College freshman at UCF
• Endorse alcohol consumption in the past two weeks

Exclusion Criteria:

• Severe mental illness
• Under 18 years of age
• Over 21 years of age
• Unable to speak English fluently

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Assessment only Control; Participants received no intervention content. They provided assessments of past week protective strategy use, alcohol use, and alcohol problems. All assessments were delivered via an online survey.
EXPERIMENTAL: Positive Message Condition; Participants received information on the positive aspects of individuals that used protective strategies and were encouraged to report why these individuals were viewed so much more positively. They provided assessments of past week protective strategy use, alcohol use, and alcohol problems. All assessments and messaging was delivered via an online survey.	Behavioral: Deviance Regulation Theory; In the negative message condition, participants received information on the negative aspects of individuals that did not used protective strategies and were encouraged to report why these individuals were viewed so much more negatively. In the positive message condition, participants received information on the positive aspects of individuals that used protective strategies and were encouraged to report why these individuals were viewed so much more positively.
EXPERIMENTAL: Negative Message Condition; Participants received information on the negative aspects of individuals that did not used protective strategies and were encouraged to report why these individuals were viewed so much more negatively. They provided assessments of past week protective strategy use, alcohol use, and alcohol problems. All assessments and messaging was delivered via an online survey.	Behavioral: Deviance Regulation Theory; In the negative message condition, participants received information on the negative aspects of individuals that did not used protective strategies and were encouraged to report why these individuals were viewed so much more negatively. In the positive message condition, participants received information on the positive aspects of individuals that used protective strategies and were encouraged to report why these individuals were viewed so much more positively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protective Behavioral Strategies- Pre-Intervention	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past three months.	Past three months prior to intervention/study
Protective Behavioral Strategies- Initial intervention (Week 1)	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.	Past week before intervention
Protective Behavioral Strategies- Week 2	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.	Past 1 week measured- 1 week post intervention
Protective Behavioral Strategies- Week 3	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.	Past 1 week measured-2 weeks post intervention
Protective Behavioral Strategies- Week 4	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.	Past 1 week measured-3 weeks post intervention
Protective Behavioral Strategies- Week 5	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.	Past 1 week measured-4 weeks post intervention
Protective Behavioral Strategies- Week 6	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.	Past 1 week measured-5 weeks post intervention
Protective Behavioral Strategies- 3 month follow up	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past three months.	Past 3 months measured- 12 week post intervention
Protective Behavioral Strategies- 6 month follow-up	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past three months.	Past 3 months measured- 26 weeks post intervention
Protective Behavioral Strategies- 12 month follow-up	Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (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). These PBS were assessed in this study using 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 was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past three months.	Past 3 months measured- 52 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol-related consequences- Pre-intervention	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past three months.	Past three months prior to intervention/study
Alcohol-related consequences- Initial intervention (Week 1)	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.	Past week before intervention
Alcohol-related consequences- Week 2	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.	Past 1 week measured- 1 week post intervention
Alcohol-related consequences- Week 3	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.	Past 1 week measured- 2 week post intervention
Alcohol-related consequences- Week 4	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.	Past 1 week measured- 3 week post intervention
Alcohol-related consequences- Week 5	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.	Past 1 week measured- 4 week post intervention
Alcohol-related consequences- Week 6	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.	Past 1 week measured- 5 week post intervention
Alcohol-related consequences- 3 month follow up	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past three months.	Past 3 months measured- 12 week post intervention
Alcohol-related consequences- 6 month follow-up	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past three months.	Past 3 months measured- 26 weeks post intervention
Alcohol-related consequences- 12 month follow-up	Alcohol-related consequences was 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 recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past three months.	Past 3 months measured- 52 weeks post intervention
Alcohol use- Pre-intervention	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure average alcohol consumption and time spent drinking during a typical week over the past three months. The DDQ-M is composed of a free-text grid where individuals report the number of drinks typically consumed for each day of the week for the past three months.	Past three months prior to intervention/study
Alcohol use- Initial intervention (Week 1)	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.	Past week before intervention
Alcohol use- Week 2	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.	Past 1 week measured- 1 week post intervention
Alcohol use- Week 3	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.	Past 1 week measured- 2 weeks post intervention
Alcohol use- Week 4	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.	Past 1 week measured- 3 weeks post intervention
Alcohol use- Week 5	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.	Past 1 week measured- 4 weeks post intervention
Alcohol use- Week 6	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.	Past 1 week measured- 5 weeks post intervention
Alcohol use- 3 month follow up	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure average alcohol consumption and time spent drinking during a typical week over the past three months. The DDQ-M is composed of a free-text grid where individuals report the number of drinks typically consumed for each day of the week for the past three months.	Past 3 months measured- 12 week post intervention
Alcohol use- 6 month follow up	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure average alcohol consumption and time spent drinking during a typical week over the past three months. The DDQ-M is composed of a free-text grid where individuals report the number of drinks typically consumed for each day of the week for the past three months.	Past 3 months measured- 24 week post intervention
Alcohol use- 12 month follow up	Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure average alcohol consumption and time spent drinking during a typical week over the past three months. The DDQ-M is composed of a free-text grid where individuals report the number of drinks typically consumed for each day of the week for the past three months.	Past 3 months measured- 52 week post intervention

Collaborators and Investigators

• Sponsor: University of Central Florida

Publications and helpful links

General Publications

• Leary AV, Dvorak RD, Troop-Gordon W, Blanton H, Peterson R, Kramer MP, De Leon AN, Magri T. Test of a deviance regulation theory intervention among first-year college student drinkers: Differential effects via frequency and quantity norms. Psychol Addict Behav. 2022 Sep;36(6):619-634. doi: 10.1037/adb0000777. Epub 2021 Sep 30.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2017
• Primary Completion (ACTUAL): August 13, 2019
• Study Completion (ACTUAL): August 13, 2019

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (ACTUAL): January 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Alcohol Use; Deviance Regulation Theory; Protective Behavioral Strategies; Alcohol Consequences; College Freshman
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: SBE-17-13260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be stored at the Open Science Framework
• IPD Sharing Time Frame: At completion of study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Study Data/Documents

1. Individual Participant Data Set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No