Alcohol Abuse
Conditions
Brief summary
In this fast-track STTR, Phase 1 will develop and test a mobile phone app among 40 adult community college students. The app is designed to reduce risky drinking behaviors and improve user safety. In Phase 2 the app (CARES) will be tested with 200 adult community college students who drink alcohol. Participants will be randomly assigned to the CARES app or an alcohol education control condition and will use the app for 12 weeks. Six month outcomes will assess changes in drinking related behaviors.
Detailed description
This STTR builds on our successful pilot that developed a text message-delivered alcohol intervention for, and in collaboration with CCS. Phase I will develop and test a smart phone application (the Cares app) incorporating the text message program with additional features and functionality requested by students in the pilot trial (Aim 1.1). After obtaining user feedback (Aim 1.2) programming will be completed in both iOS and Android languages. To ensure that the College Alcohol Risk Education System (CARES) is well positioned to get into the community college marketplace, it is critical to demonstrate efficacy. Phase 2 will conduct an efficacy trial of CARES compared to a competing alcohol education program that would be feasible for most community colleges to adopt, thus providing a real-world comparison with data suitable to support future efforts toward commercialization. This study will also identify the types of individuals for whom CARES is more/less effective and identify how it might be improved.
Interventions
BEHAVIORALCARES mobile smart phone app
The CARES smart phone mobile app contains a number of features to support safety while drinking and reduced alcohol consumption plus regular test messages for personal support
BEHAVIORALCheck Your Drinking
Check Your Drinking is an online alcohol assessment that provides normative feedback on the user's drinking habits relative to his/her peers. Alcohol interventions that provide normative feedback are rated by the NIAAA Alcohol Intervention Matrix as effective and low cost, and with few administrative or structural barriers to implementation thus making it suitable for community colleges.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors will be blind to the participant's randomization assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* Currently enrolled community college student * At least 2 heavy drinking episodes in past 2 weeks at recruitment * Own smart phone
Exclusion criteria
* Alcohol abuse disorder or currently in treatment for alcohol-related problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drinks Per Week | 30 days | Average drinks based on 30 day timeline follow back of all alcohol consumption |
| Alcohol Related Consequences | 30 days | Negative life events related to drinking assessed by the Brief Young Adult Alcohol Consequences Questionnaire. Calculates a total score from 0-48, with higher numbers indicating worse outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Situational Confidence | 12 weeks | Confidence in drinking resistance assessed by the Brief Situational Confidence Questionnaire. Scores 8 items from 0% to 100% confidence with higher scores indicating better confidence. |
| Protective Strategies | 12 weeks | Skills in using alcohol-protective behaviors measured by the Protective Behavioral Strategies Survey. A 15-item survey, each item is scored from 0 to 6 to indicate use of behavioral strategies and the total score is a sum of all items. Higher scores indicate more (better) use of protective strategies. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CARES Mobile App Participants in this arm will receive 12 weeks of text messages and use of the smart phone mobile app that provides support for alcohol risk reduction.
CARES mobile smart phone app: The CARES smart phone mobile app contains a number of features to support safety while drinking and reduced alcohol consumption plus regular test messages for personal support | 118 |
| Alcohol Education Those randomized to the control arm will be given access to an online alcohol education intervention; Check Your Drinking (CYD: www.CheckYourDrinking.net). CYD provides normative feedback on the user's drinking habits relative to his/her peers.
Check Your Drinking: Check Your Drinking is an online alcohol assessment that provides normative feedback on the user's drinking habits relative to his/her peers. Alcohol interventions that provide normative feedback are rated by the NIAAA Alcohol Intervention Matrix as effective and low cost, and with few administrative or structural barriers to implementation thus making it suitable for community colleges. | 121 |
| Total | 239 |
Baseline characteristics
| Characteristic | CARES Mobile App | Alcohol Education | Total |
|---|---|---|---|
| Age, Continuous | 22.9 Years STANDARD_DEVIATION 3.2 | 22.9 Years STANDARD_DEVIATION 3.3 | 22.9 Years STANDARD_DEVIATION 3.3 |
| Binge Drinking Days | 0.86 days | 0.88 days | 0.87 days |
| Drinks per week | 7.81 drinks STANDARD_DEVIATION 7.24 | 7.78 drinks STANDARD_DEVIATION 6.62 | 7.79 drinks STANDARD_DEVIATION 6.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 21 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants | 100 Participants | 195 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 | 12 Participants | 8 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 25 Participants | 50 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 5 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) White | 63 Participants | 80 Participants | 143 Participants |
| Region of Enrollment United States | 118 participants | 121 participants | 239 participants |
| Sex: Female, Male Female | 83 Participants | 85 Participants | 168 Participants |
| Sex: Female, Male Male | 35 Participants | 36 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 121 |
| other Total, other adverse events | 0 / 118 | 0 / 121 |
| serious Total, serious adverse events | 0 / 118 | 0 / 121 |
Outcome results
Primary
Alcohol Related Consequences
Negative life events related to drinking assessed by the Brief Young Adult Alcohol Consequences Questionnaire. Calculates a total score from 0-48, with higher numbers indicating worse outcomes.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Mobile App | Alcohol Related Consequences | 4.34 score on a scale | Standard Deviation 5.94 |
| Alcohol Education | Alcohol Related Consequences | 4.95 score on a scale | Standard Deviation 6.12 |
Primary
Drinks Per Week
Average drinks based on 30 day timeline follow back of all alcohol consumption
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Mobile App | Drinks Per Week | 4.05 drinks | Standard Deviation 4.83 |
| Alcohol Education | Drinks Per Week | 5.58 drinks | Standard Deviation 6.29 |
Secondary
Protective Strategies
Skills in using alcohol-protective behaviors measured by the Protective Behavioral Strategies Survey. A 15-item survey, each item is scored from 0 to 6 to indicate use of behavioral strategies and the total score is a sum of all items. Higher scores indicate more (better) use of protective strategies.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Mobile App | Protective Strategies | 3.65 score on a scale | Standard Deviation 0.69 |
| Alcohol Education | Protective Strategies | 3.48 score on a scale | Standard Deviation 0.73 |
Secondary
Situational Confidence
Confidence in drinking resistance assessed by the Brief Situational Confidence Questionnaire. Scores 8 items from 0% to 100% confidence with higher scores indicating better confidence.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CARES Mobile App | Situational Confidence | 72.6 score on a scale | Standard Deviation 21.4 |
| Alcohol Education | Situational Confidence | 74.6 score on a scale | Standard Deviation 19.6 |