- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05065918
Text Message Intervention for Alcohol Use and Sexual Violence in College Students
Text Message Intervention for Alcohol Use and Sexual Violence in College Students (STUDY00010873)
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control - alcohol use reduction content
Alcohol use reduction content
|
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).
|
|
Experimental: Intervention - sexual violence and alcohol use harm reduction content
sexual violence and alcohol use harm reduction content
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Drinking Days Per Month
Time Frame: 3 month follow up
|
as measured using a 30-day timeline follow-back (TLFB)
|
3 month follow up
|
|
Number of Drinking Days Per Month
Time Frame: 6 month follow up
|
as measured using a 30-day timeline follow-back (TLFB)
|
6 month follow up
|
|
Number of Binge Drinking Days Per Month
Time Frame: 3 month follow up
|
as measured using a 30-day timeline follow-back (TLFB)
|
3 month follow up
|
|
Number of Binge Drinking Days Per Month
Time Frame: 6 month follow up
|
as measured using a 30-day timeline follow-back (TLFB)
|
6 month follow up
|
|
Use of Sexual Violence Harm Reduction Strategies
Time Frame: 3 month follow up
|
Use of sexual violence harm reduction strategies assessed with an 11 item scale used by the American College Health Association's National College Health Survey of Protective Behavioral Strategies.
Participants report on how often when drinking/socializing in the past 3 months they used each of the specific behaviors on a 5-point Likert scale ranging from (1 = never, 5 = always; theoretical range 11-55) with higher scores indicating higher frequency use of harm reduction strategies.
|
3 month follow up
|
|
Use of Sexual Violence Harm Reduction Strategies
Time Frame: 6 month follow up
|
Use of sexual violence harm reduction strategies assessed with an 11 item scale used by the American College Health Association's National College Health Survey of Protective Behavioral Strategies.
Participants report on how often when drinking/socializing in the past 3 months they used each of the specific behaviors on a 5-point Likert scale ranging from (1 = never, 5 = always; theoretical range 11-55) with higher scores indicating higher frequency use of harm reduction strategies.
|
6 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of Sexual Violence and Alcohol Risk
Time Frame: 3 month follow up
|
Alcohol and sexual consent scale. A series of questions were asked to measure recognition of what constitutes sexual violence and attitudes related to the role of alcohol in risk for sexual violence. 12 item scale, using a 5-point Likert scale ranging from ("strongly disagree" to "strongly agree"; theoretical range of 12-60), with a higher mean score indicating greater knowledge and recognition. |
3 month follow up
|
|
Knowledge of Sexual Violence and Alcohol Risk
Time Frame: 6 month follow up
|
Alcohol and sexual consent scale. A series of questions were asked to measure recognition of what constitutes sexual violence and attitudes related to the role of alcohol in risk for sexual violence. 12 item scale, using a 5-point Likert scale ranging from ("strongly disagree" to "strongly agree"; theoretical range of 12-60), with a higher mean score indicating greater knowledge and recognition. |
6 month follow up
|
|
Self-efficacy to Obtain Sexual Consent.
Time Frame: 3 month follow up
|
Perceived behavioral control subscale of the Sexual Consent Scale-Revised.
Participants reported how efficacious they feel at obtaining consent for sexual activity of a 5-point Likert scale.
11 item scale ("strongly disagree" to "strongly agree"; theoretical range of 11-55).
Higher scores indicate greater self-efficacy.
|
3 month follow up
|
|
Self-efficacy to Obtain Sexual Consent.
Time Frame: 6 month follow up
|
Perceived behavioral control subscale of the Sexual Consent Scale-Revised.
Participants reported how efficacious they feel at obtaining consent for sexual activity of a 5-point Likert scale.
11 item scale ("strongly disagree" to "strongly agree"; theoretical range of 11-55).
Higher scores indicate greater self-efficacy.
|
6 month follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jocelyn Anderson, University of Arkansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 275726
- K23AA027288 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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