Longitudinal Use of Protective Behavioral Strategies

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Longitudinal Use of Protective Behavioral Strategies

Conditions
-----------------
Alcohol Use, Unspecified

Intervention / Treatment
-----------------
* Behavioral: Deviance Regulation Theory


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomly assigned to 1 of 3 parallel conditions. After assignment, they received a brief intervention and were then followed for the next 12 months.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Assessment only Control<br>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<br>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<br>* 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.<br>|
| Experimental: Negative Message Condition<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
College Freshman, Deviance Regulation Theory, Alcohol Use, Alcohol Consequences, Protective Behavioral Strategies