Longitudinal Use of Protective Behavioral Strategies

NCT04699955 | Completed

• 1 other identifier: SBE-17-13260
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use, Unspecified

Keywords

Deviance Regulation Theory; Alcohol Use; Alcohol Consequences; Protective Behavioral Strategies; College Freshman

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (20)

• Alcohol-related consequences- Pre-intervention

  Past three months prior to intervention/study

• Alcohol-related consequences- Initial intervention (Week 1)

  Past week before intervention

• Alcohol-related consequences- Week 2

  Past 1 week measured- 1 week post intervention

• Alcohol-related consequences- Week 3

  Past 1 week measured- 2 week post intervention

• Alcohol-related consequences- Week 4

  Past 1 week measured- 3 week post intervention

Study Arms (3)

Assessment only Control

NO INTERVENTION

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.

Positive Message Condition

EXPERIMENTAL

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

Negative Message Condition

EXPERIMENTAL

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

Interventions

Deviance Regulation Theory BEHAVIORAL

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.

Negative Message Condition; Positive Message Condition

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

The University of central Florida

Orlando, Florida, 32816-0001, United States

Location

Related Publications (1)

• 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.

  PMID: 34591518 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: January 7, 2021
• Study Start: August 14, 2017
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: At completion of study

Locations

US (1)