Text Message Intervention for Alcohol Use and Sexual Violence in College Students
Primary Purpose
Alcohol Use, Unspecified, Sexual Violence, Sexual Assault
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sexual violence and alcohol use harm reduction text message content
alcohol use reduction content
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Use, Unspecified
Eligibility Criteria
Inclusion Criteria:
- age 18-24 years,
- current college or university student,
- owns a mobile phone with internet access and unlimited text message plan,
- reports binge drinking in the past 30 days [>3 drinks for women, >4 drinks men in one sitting]
- Able to complete participation in English.
- To evaluate messages tailored to prior SV victimization, approximately 50% of the sample will also be purposively recruited for a baseline history of SV.
Exclusion Criteria:
- Under 18 years old, over 24 years old
- Not currently enrolled in college
- Does not own a mobile phone with internet access and unlimited data plan
- Does not report binge drinking in the past 30 day
- Unable to complete study participation in English
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control - alcohol use reduction content
Intervention - sexual violence and alcohol use harm reduction content
Arm Description
Alcohol use reduction content
sexual violence and alcohol use harm reduction content
Outcomes
Primary Outcome Measures
number of drinking days per month
as measured using a 30-day timeline follow-back (TLFB)
number of drinking days per month
as measured using a 30-day timeline follow-back (TLFB)
number of binge drinking days per month
as measured using a 30-day timeline follow-back (TLFB)
number of binge drinking days per month
as measured using a 30-day timeline follow-back (TLFB)
use of sexual violence harm reduction strategies
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
use of sexual violence harm reduction strategies
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
Secondary Outcome Measures
knowledge of sexual violence harm reduction behaviors
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
knowledge of sexual violence harm reduction behaviors
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
self-efficacy to use sexual violence harm reduction behaviors
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
self-efficacy to use sexual violence harm reduction behaviors
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
Full Information
NCT ID
NCT05065918
First Posted
September 16, 2021
Last Updated
August 18, 2023
Sponsor
University of Arkansas
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Penn State University
1. Study Identification
Unique Protocol Identification Number
NCT05065918
Brief Title
Text Message Intervention for Alcohol Use and Sexual Violence in College Students
Official Title
Text Message Intervention for Alcohol Use and Sexual Violence in College Students
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Penn State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to pilot a text message (TM) delivered behavior change intervention to decrease binge drinking and to increase use of sexual violence (SV) harm reduction strategies among college students.
Detailed Description
This is a prospective, open-label, feasibility trial of a text message-delivered intervention designed to increase use of sexual violence harm reduction strategies and decrease alcohol use among college students.
In this research study, participants will:
be asked to complete three surveys, one survey at the start of the study, one at the end of 3 month intervention period, and one at 6 months after enrollment
receive one of two sets of text messages for a 3 month intervention period and be asked to respond to some of those text messages
Control condition text messages: The control condition will be a version of the TM-delivered alcohol use reduction intervention developed and implemented by Dr. Brian Suffoletto while at the University of Pittsburgh. This intervention has been tested in young adults (age 18-25) recruited from Emergency Department and college settings, and will be used to provide an attention control group for efficacy testing. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. abstinence feedback, high risk drinking feedback).
Intervention condition text messages: The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented at the University of Pittsburgh.13-15 Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Unspecified, Sexual Violence, Sexual Assault
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control - alcohol use reduction content
Arm Type
Active Comparator
Arm Description
Alcohol use reduction content
Arm Title
Intervention - sexual violence and alcohol use harm reduction content
Arm Type
Experimental
Arm Description
sexual violence and alcohol use harm reduction content
Intervention Type
Behavioral
Intervention Name(s)
sexual violence and alcohol use harm reduction text message content
Intervention Description
The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
Intervention Type
Behavioral
Intervention Name(s)
alcohol use reduction content
Intervention Description
The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: "Would you be willing to set a goal to drink less than X drinks when drinking?". Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback).
Primary Outcome Measure Information:
Title
number of drinking days per month
Description
as measured using a 30-day timeline follow-back (TLFB)
Time Frame
3 month follow up
Title
number of drinking days per month
Description
as measured using a 30-day timeline follow-back (TLFB)
Time Frame
6 month follow up
Title
number of binge drinking days per month
Description
as measured using a 30-day timeline follow-back (TLFB)
Time Frame
3 month follow up
Title
number of binge drinking days per month
Description
as measured using a 30-day timeline follow-back (TLFB)
Time Frame
6 month follow up
Title
use of sexual violence harm reduction strategies
Description
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
Time Frame
3 month follow up
Title
use of sexual violence harm reduction strategies
Description
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
Time Frame
6 month follow up
Secondary Outcome Measure Information:
Title
knowledge of sexual violence harm reduction behaviors
Description
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
Time Frame
3 month follow up
Title
knowledge of sexual violence harm reduction behaviors
Description
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
Time Frame
6 month follow up
Title
self-efficacy to use sexual violence harm reduction behaviors
Description
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
Time Frame
3 month follow up
Title
self-efficacy to use sexual violence harm reduction behaviors
Description
Modified Dating Self-Protection Against Rape Scale (DSPARS). A series of questions about frequency of use of 15 behavioral strategies to protect against sexual assault (e.g. "meet in a public place instead of a private place" and "tell a friend who you are meeting and where"). In addition to use of each strategy, each item will be used to assess knowledge ("How aware of…") and self-efficacy ("How confident in your ability to…") for each strategy. ( ∝ = 0.86).
Time Frame
6 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-24 years,
current college or university student,
owns a mobile phone with internet access and unlimited text message plan,
reports binge drinking in the past 30 days [>3 drinks for women, >4 drinks men in one sitting]
Able to complete participation in English.
To evaluate messages tailored to prior SV victimization, approximately 50% of the sample will also be purposively recruited for a baseline history of SV.
Exclusion Criteria:
Under 18 years old, over 24 years old
Not currently enrolled in college
Does not own a mobile phone with internet access and unlimited data plan
Does not report binge drinking in the past 30 day
Unable to complete study participation in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn Anderson
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Text Message Intervention for Alcohol Use and Sexual Violence in College Students
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