Trial Outcomes & Findings for CARES: A Mobile Health Program for Alcohol Risk Reduction (NCT NCT03927482)
NCT ID: NCT03927482
Last Updated: 2025-03-26
Results Overview
Average drinks based on 30 day timeline follow back of all alcohol consumption
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
239 participants
Primary outcome timeframe
30 days
Results posted on
2025-03-26
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
121
|
|
Overall Study
COMPLETED
|
110
|
115
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CARES: A Mobile Health Program for Alcohol Risk Reduction
Baseline characteristics by cohort
| Measure |
CARES Mobile App
n=118 Participants
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
|
Alcohol Education
n=121 Participants
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.
|
Total
n=239 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.9 Years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
22.9 Years
STANDARD_DEVIATION 3.3 • n=7 Participants
|
22.9 Years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
63 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
118 participants
n=5 Participants
|
121 participants
n=7 Participants
|
239 participants
n=5 Participants
|
|
Drinks per week
|
7.81 drinks
STANDARD_DEVIATION 7.24 • n=5 Participants
|
7.78 drinks
STANDARD_DEVIATION 6.62 • n=7 Participants
|
7.79 drinks
STANDARD_DEVIATION 6.93 • n=5 Participants
|
|
Binge Drinking Days
|
0.86 days
n=5 Participants
|
0.88 days
n=7 Participants
|
0.87 days
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysAverage drinks based on 30 day timeline follow back of all alcohol consumption
Outcome measures
| Measure |
CARES Mobile App
n=118 Participants
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
|
Alcohol Education
n=121 Participants
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.
|
|---|---|---|
|
Drinks Per Week
|
4.05 drinks
Standard Deviation 4.83
|
5.58 drinks
Standard Deviation 6.29
|
PRIMARY outcome
Timeframe: 30 daysNegative 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.
Outcome measures
| Measure |
CARES Mobile App
n=118 Participants
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
|
Alcohol Education
n=121 Participants
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.
|
|---|---|---|
|
Alcohol Related Consequences
|
4.34 score on a scale
Standard Deviation 5.94
|
4.95 score on a scale
Standard Deviation 6.12
|
SECONDARY outcome
Timeframe: 12 weeksConfidence in drinking resistance assessed by the Brief Situational Confidence Questionnaire. Scores 8 items from 0% to 100% confidence with higher scores indicating better confidence.
Outcome measures
| Measure |
CARES Mobile App
n=118 Participants
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
|
Alcohol Education
n=121 Participants
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.
|
|---|---|---|
|
Situational Confidence
|
72.6 score on a scale
Standard Deviation 21.4
|
74.6 score on a scale
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: 12 weeksSkills 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.
Outcome measures
| Measure |
CARES Mobile App
n=118 Participants
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
|
Alcohol Education
n=121 Participants
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.
|
|---|---|---|
|
Protective Strategies
|
3.65 score on a scale
Standard Deviation 0.69
|
3.48 score on a scale
Standard Deviation 0.73
|
Adverse Events
CARES Mobile App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place