Longitudinal Use of Protective Behavioral Strategies

Alcohol Use, Unspecified Clinical Trial

Official title:

Longitudinal Use of Protective Behavioral Strategies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699955
• Other study ID #: SBE-17-13260
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: August 13, 2019

Study information

• Verified date: January 2021
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: August 13, 2019
• Est. primary completion date: August 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protective Behavioral Strategies- Pre-Intervention	Protective behavioral strategies (PBS) are 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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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