Clinical trial NCT05065918: 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 (STUDY00010873)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use, Unspecified
Sexual Violence
Sexual Assault
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: University of Pittsburgh
name: Penn State University
First posted: 2021-10-04
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. age 18-24 years,
2. current college or university student,
3. owns a mobile phone with internet access and unlimited text message plan,
4. reports binge drinking in the past 30 days \[\>3 drinks for women, \>4 drinks men in one sitting\]
5. Able to complete participation in English.
6. 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:

1. Under 18 years old, over 24 years old
2. Not currently enrolled in college
3. Does not own a mobile phone with internet access and unlimited data plan
4. Does not report binge drinking in the past 30 day
5. Unable to complete study participation in English

Primary outcomes:
measure: Number of Drinking Days Per Month
timeFrame: 3 month follow up
measure: Number of Drinking Days Per Month
timeFrame: 6 month follow up
measure: Number of Binge Drinking Days Per Month
timeFrame: 3 month follow up
measure: Number of Binge Drinking Days Per Month
timeFrame: 6 month follow up
measure: Use of Sexual Violence Harm Reduction Strategies
timeFrame: 3 month follow up
measure: Use of Sexual Violence Harm Reduction Strategies
timeFrame: 6 month follow up
Secondary outcomes:
measure: Knowledge of Sexual Violence and Alcohol Risk
timeFrame: 3 month follow up
measure: Knowledge of Sexual Violence and Alcohol Risk
timeFrame: 6 month follow up
measure: Self-efficacy to Obtain Sexual Consent.
timeFrame: 3 month follow up
measure: Self-efficacy to Obtain Sexual Consent.
timeFrame: 6 month follow up
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Jocelyn Anderson
role: PRINCIPAL_INVESTIGATOR
References: