DRT Mobile Intervention to Increase Safe Drinking

NCT05098639 | Unknown

• 1 other identifier: STUDY00001422
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alcohol; Use, Problem

Keywords

Alcohol Use; Deviance Regulation Theory; Mobile Intervention; Protective Behavioral Strategies

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Past 3 months measured- 26 weeks post intervention

Secondary Outcomes (14)

• 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)

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.

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.

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.

Behavioral: BASICS; Behavioral: Deviance Regulation Theory (DRT)

Interventions

BASICS BEHAVIORAL

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.

BASICS; Deviance Regulation Theory+BASICS

Deviance Regulation Theory (DRT) BEHAVIORAL

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.

Deviance Regulation Theory; Deviance Regulation Theory+BASICS

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Severe mental illness
• Under 18 years of age
• Over 26 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, United States

Location

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of the condition they are in. As the initial session requires a brief individual session using BASICS, DRT, or DRT+BASICS, investigators will be aware of study condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will randomly assign participants to one of three conditions: Active Control (BASICS), DRT, or DRT+Active Control

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 28, 2021
• Study Start: March 3, 2022
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 mo. post data collection

Locations

US (1)