Alcohol Use, UnspecifiedNCT05065918
Text Message Intervention for Alcohol Use and Sexual Violence in College Students
A study testing sexual violence and alcohol use harm reduction text message content and alcohol use reduction content in people with Alcohol Use, Unspecified and Sexual Violence, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Unspecified, Sexual Violence, Sexual Assault
- What is being tested?
- sexual violence and alcohol use harm reduction text message content and alcohol use reduction content
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Text Message Intervention for Alcohol Use and Sexual Violence in College Students (STUDY00010873)
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.
Read the 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.
- Conditions
- Alcohol Use, Unspecified, Sexual Violence, Sexual Assault
- Being tested
- sexual violence and alcohol use harm reduction text message content, alcohol use reduction content
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexual violence and alcohol use harm reduction text message contentBehavioural
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.
alcohol use reduction contentBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Control - alcohol use reduction content | Active comparator | Alcohol use reduction content Receives: Behavioral: alcohol use reduction content |
| Intervention - sexual violence and alcohol use harm reduction content | Experimental | sexual violence and alcohol use harm reduction content Receives: Behavioral: sexual violence and alcohol use harm reduction text message content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drinking Days Per Month
as measured using a 30-day timeline follow-back (TLFB)
Measured: 3 month follow up
Number of Drinking Days Per Month
as measured using a 30-day timeline follow-back (TLFB)
Measured: 6 month follow up
Number of Binge Drinking Days Per Month
as measured using a 30-day timeline follow-back (TLFB)
Measured: 3 month follow up
Number of Binge Drinking Days Per Month
as measured using a 30-day timeline follow-back (TLFB)
Measured: 6 month follow up
Use of Sexual Violence Harm Reduction Strategies
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.
Measured: 3 month follow up
Use of Sexual Violence Harm Reduction Strategies
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.
Measured: 6 month follow up
Secondary outcomes (4)
Knowledge of Sexual Violence and Alcohol Risk
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.
Measured: 3 month follow up
Knowledge of Sexual Violence and Alcohol Risk
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.
Measured: 6 month follow up
Self-efficacy to Obtain Sexual Consent.
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.
Measured: 3 month follow up
Self-efficacy to Obtain Sexual Consent.
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.
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start4 Nov 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Penn State University
- Responsible party
- Sponsor
- Investigators
- Jocelyn Anderson, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065918
- Sponsor's protocol ID
- 275726
- Other IDs
- K23AA027288
- Status last verified
- Feb 2024
- First submitted
- 16 Sep 2021
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Message Intervention for Alcohol Use and Sexual Violence in College Students (STUDY00010873)
- ClinicalTrials.gov ID
- NCT05065918
- Acronym / sponsor ID
- 275726
- Conditions
- Alcohol Use, Unspecified, Sexual Violence, Sexual Assault
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Pittsburgh, Penn State University
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - alcohol use reduction content | Active comparator | Behavioral: alcohol use reduction contentAlcohol use reduction content |
| Intervention - sexual violence and alcohol use harm reduction content | Experimental | Behavioral: sexual violence and alcohol use harm reduction text message contentsexual violence and alcohol use harm reduction content |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sexual violence and alcohol use harm reduction text message contentThe 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. | Behavioural | Intervention - sexual violence and alcohol use harm reduction content |
| alcohol use reduction contentThe 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). | Behavioural | Control - alcohol use reduction content |
Primary outcome
Number of Drinking Days Per Month
Time frame: 3 month follow up
as measured using a 30-day timeline follow-back (TLFB)
Number of Drinking Days Per Month
Time frame: 6 month follow up
as measured using a 30-day timeline follow-back (TLFB)
Number of Binge Drinking Days Per Month
Time frame: 3 month follow up
as measured using a 30-day timeline follow-back (TLFB)
Number of Binge Drinking Days Per Month
Time frame: 6 month follow up
as measured using a 30-day timeline follow-back (TLFB)
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.
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.
4 secondary outcomes
Knowledge of Sexual Violence and Alcohol Risk
Time frame: 3 month follow up
Knowledge of Sexual Violence and Alcohol Risk
Time frame: 6 month follow up
Self-efficacy to Obtain Sexual Consent.
Time frame: 3 month follow up
Self-efficacy to Obtain Sexual Consent.
Time frame: 6 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn Anderson principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexual violence and alcohol use harm reduction text message content and alcohol use reduction content in people with Alcohol Use, Unspecified and Sexual Violence, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Drinking Days Per Month (time frame: 3 month follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.