Alcohol Use, Unspecified, Sexual Assault, Sexual Violence
Conditions
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.
Interventions
BEHAVIORALsexual violence and alcohol use harm reduction text message 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.
BEHAVIORALalcohol 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).
Sponsors
National Institutes of Health (NIH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Pittsburgh
Penn State University
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drinking Days Per Month | 3 month follow up | as measured using a 30-day timeline follow-back (TLFB) |
| Number of Binge Drinking Days Per Month | 3 month follow up | as measured using a 30-day timeline follow-back (TLFB) |
| Use of Sexual Violence Harm Reduction Strategies | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of Sexual Violence and Alcohol Risk | 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. |
| Self-efficacy to Obtain Sexual Consent. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control - Alcohol Use Reduction Content 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). | 92 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content sexual violence and alcohol use harm reduction content
sexual violence and alcohol use harm reduction text message 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. | 91 |
| Total | 183 |
Baseline characteristics
| Characteristic | Control - Alcohol Use Reduction Content | Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants | 91 Participants | 183 Participants |
| Age, Continuous | 20 years STANDARD_DEVIATION 1.07 | 21 years STANDARD_DEVIATION 1.47 | 20 years STANDARD_DEVIATION 1.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants | 83 Participants | 170 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 73 Participants | 73 Participants | 146 Participants |
| Region of Enrollment United States | 92 participants | 91 participants | 183 participants |
| Sex: Female, Male Female | 73 Participants | 69 Participants | 142 Participants |
| Sex: Female, Male Male | 19 Participants | 22 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 92 | 0 / 91 |
| other Total, other adverse events | 0 / 92 | 0 / 91 |
| serious Total, serious adverse events | 0 / 92 | 0 / 91 |
Outcome results
Primary
Number of Binge Drinking Days Per Month
as measured using a 30-day timeline follow-back (TLFB)
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Number of Binge Drinking Days Per Month | 6.45 binge drinking days in the past 30 days | Standard Deviation 4.5 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Number of Binge Drinking Days Per Month | 5.91 binge drinking days in the past 30 days | Standard Deviation 4.97 |
Comparison: Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.p-value: 0.23195% CI: [-1.322, 0.322]Regression, Linear
Primary
Number of Binge Drinking Days Per Month
as measured using a 30-day timeline follow-back (TLFB)
Time frame: 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Number of Binge Drinking Days Per Month | 2.03 binge drinking days in the past 30 days | Standard Deviation 2.55 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Number of Binge Drinking Days Per Month | 1.71 binge drinking days in the past 30 days | Standard Deviation 2.51 |
Comparison: Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.p-value: 0.39895% CI: [-1.064, 0.425]Regression, Linear
Primary
Number of Drinking Days Per Month
as measured using a 30-day timeline follow-back (TLFB)
Time frame: 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Number of Drinking Days Per Month | 5.98 drinking days in the past 30 days | Standard Deviation 3.84 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Number of Drinking Days Per Month | 6.00 drinking days in the past 30 days | Standard Deviation 3.85 |
Comparison: Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.p-value: 0.96995% CI: [-1.152, 1.108]Regression, Linear
Primary
Number of Drinking Days Per Month
as measured using a 30-day timeline follow-back (TLFB)
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Number of Drinking Days Per Month | 6.45 drinking days in the past 30 days | Standard Deviation 4.5 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Number of Drinking Days Per Month | 5.91 drinking days in the past 30 days | Standard Deviation 4.97 |
Comparison: Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.p-value: 0.44895% CI: [-1.929, 0.857]Regression, Linear
Primary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Use of Sexual Violence Harm Reduction Strategies | 37.26 score on a scale | Standard Deviation 6.19 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Use of Sexual Violence Harm Reduction Strategies | 36.20 score on a scale | Standard Deviation 6.33 |
Comparison: Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.p-value: 0.26695% CI: [-0.284, 1.025]Regression, Linear
Primary
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.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Use of Sexual Violence Harm Reduction Strategies | 36.72 score on a scale | Standard Deviation 6.38 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Use of Sexual Violence Harm Reduction Strategies | 37.26 score on a scale | Standard Deviation 6.19 |
Comparison: Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.p-value: 0.38295% CI: [-0.356, 0.924]Regression, Linear
Secondary
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.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Knowledge of Sexual Violence and Alcohol Risk | 37.35 score on a scale | Standard Deviation 3.95 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Knowledge of Sexual Violence and Alcohol Risk | 36.72 score on a scale | Standard Deviation 3.72 |
p-value: 0.01995% CI: [0.089, 0.97]Regression, Linear
Secondary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Knowledge of Sexual Violence and Alcohol Risk | 37.11 score on a scale | Standard Deviation 3.58 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Knowledge of Sexual Violence and Alcohol Risk | 36.70 score on a scale | Standard Deviation 5.51 |
Comparison: Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.p-value: 0.28495% CI: [-0.232, 0.787]Regression, Linear
Secondary
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.
Time frame: 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Self-efficacy to Obtain Sexual Consent. | 42.78 score on a scale | Standard Deviation 7.03 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Self-efficacy to Obtain Sexual Consent. | 40.92 score on a scale | Standard Deviation 7.74 |
Comparison: Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.p-value: 0.07695% CI: [-0.076, 1.494]Regression, Linear
Secondary
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.
Time frame: 6 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control - Alcohol Use Reduction Content | Self-efficacy to Obtain Sexual Consent. | 42.42 score on a scale | Standard Deviation 7.29 |
| Intervention - Sexual Violence and Alcohol Use Harm Reduction Content | Self-efficacy to Obtain Sexual Consent. | 40.53 score on a scale | Standard Deviation 7.42 |
Comparison: Pilot sample size considerations: Assessing 70 students per arm (total n=140) that have completed the program and follow up would provide sufficient data on the full RCT protocol across multiple campuses as well as estimates of intervention effects. Assuming a retention rate of 70% for the three-month follow up, we would need to enroll 200 participants at baseline. We do not anticipate sufficient power to detect statistically and clinically significant results.p-value: 0.13695% CI: [-0.199, 1.449]Regression, Linear