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| ID | Type | Description | Link |
|---|---|---|---|
| K23AA027288 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| University of Pittsburgh | OTHER |
| Penn State University |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - alcohol use reduction content | Active Comparator | Alcohol use reduction content |
|
| Intervention - sexual violence and alcohol use harm reduction content | Experimental | sexual violence and alcohol use harm reduction content |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sexual violence and alcohol use harm reduction text message content | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinking Days Per Month | as measured using a 30-day timeline follow-back (TLFB) | 3 month follow up |
| Number of Drinking Days Per Month | as measured using a 30-day timeline follow-back (TLFB) | 6 month follow up |
| Number of Binge Drinking Days Per Month | as measured using a 30-day timeline follow-back (TLFB) | 3 month follow up |
| Number of Binge Drinking Days Per Month | as measured using a 30-day timeline follow-back (TLFB) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jocelyn Anderson | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Drinking Days Per Month | as measured using a 30-day timeline follow-back (TLFB) | Posted | Mean | Standard Deviation | drinking days in the past 30 days | 3 month follow up |
|
Participants were followed for six months after enrollment/baseline data collection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jocelyn Anderson | The University of Arkansas for Medical Sciences | 501-686-7712 | andersonjocelyn@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 29, 2023 | Aug 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2023 | Aug 2, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2021 | Aug 2, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| OTHER |
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|
| alcohol use reduction content | Behavioral | 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). |
|
| 6 month follow up |
| 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. | 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. | 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. | 6 month follow up |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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|
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| Primary | Number of Drinking Days Per Month | as measured using a 30-day timeline follow-back (TLFB) | Posted | Mean | Standard Deviation | drinking days in the past 30 days | 6 month follow up |
|
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|
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| Primary | Number of Binge Drinking Days Per Month | as measured using a 30-day timeline follow-back (TLFB) | Posted | Mean | Standard Deviation | binge drinking days in the past 30 days | 3 month follow up |
|
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| Primary | Number of Binge Drinking Days Per Month | as measured using a 30-day timeline follow-back (TLFB) | Posted | Mean | Standard Deviation | binge drinking days in the past 30 days | 6 month follow up |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 month follow up |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month follow up |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 month follow up |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month follow up |
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|
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 month follow up |
|
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|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 month follow up |
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|
| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | 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. | 0 | 91 | 0 | 91 | 0 | 91 |
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