Alcohol Abuse
Conditions
Keywords
alcohol, mHealth, SBIRT
Brief summary
In this study, the investigators will be developing and testing a mobile phone text message intervention to reduce alcohol use for people at risk of alcohol dependence. The investigators hypothesize that this intervention will be acceptable to participants, and that they will stay in the intervention until it's one week completion.
Interventions
BEHAVIORALmROAD
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AUDIT score 15-20 * have a mobile phone capable of receiving text messages
Exclusion criteria
* age \<18 * unable to consent * language other than English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention to Patient | 1 week | percentage of patients that do not opt out of messages prior to 1 week completion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completed Assessment at 1 Month | 1 month | Feasibility of follow up of urban low-income at risk drinkers by phone defined as number of patients can be contacted at one months to complete assessment of alcohol use |
| Change in Days Drinking Alcohol | 1 month | patients reported number of days drinking any alcohol in prior 30 days, baseline report minus 1 month follow up report |
| Change in Days Drinking Heavily in 30 Days | 1 month | patients reported number of heavy drinking days in prior 30 days (3 or more standard sized drinks per episode for women and 4 or more standard sized drinks per episode for men), baseline report minus 1 month follow up report |
| Change in Motivation to Change Score | 1 month | Participants reported desire to change via the Change Questionnaire applied to risky alcohol use.\[1\] The Change questionnaire has a Cronbach's alpha of 0.86 when applied to alcohol use.\[2\] Minimum score is 0 (low motivation to change) to maximum 120 (high motivation to change). 1. Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive behaviors. 2008;33(9):1177-1182. 2. Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive Behaviors. 2008;33(9):1177-1182. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| mROAD 1 week of twice daily text messages modeled after SBIRT interventions
mROAD | 24 |
| Usual Care Usual care in ED | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 11 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | mROAD | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 13.5 | 35.4 years STANDARD_DEVIATION 10.6 | 37.1 years STANDARD_DEVIATION 12.1 |
| Days drank alcohol in last month | 7.6 days STANDARD_DEVIATION 8.6 | 11.5 days STANDARD_DEVIATION 8.4 | 9.6 days STANDARD_DEVIATION 8.6 |
| Days drank heavily in last month | 4.9 days STANDARD_DEVIATION 7.2 | 5.5 days STANDARD_DEVIATION 7.1 | 5.2 days STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 21 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Motivation to change score | 88.8 units on a scale STANDARD_DEVIATION 6.7 | 89.3 units on a scale STANDARD_DEVIATION 33.8 | 89.1 units on a scale STANDARD_DEVIATION 32.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 22 Participants | 39 Participants |
| Region of Enrollment United States | 24 participants | 24 participants | 48 participants |
| Self report of mental illness | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 19 Participants | 21 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
Primary
Acceptability of Intervention to Patient
percentage of patients that do not opt out of messages prior to 1 week completion
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mROAD | Acceptability of Intervention to Patient | 23 Participants |
| Usual Care | Acceptability of Intervention to Patient | 24 Participants |
Secondary
Change in Days Drinking Alcohol
patients reported number of days drinking any alcohol in prior 30 days, baseline report minus 1 month follow up report
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| mROAD | Change in Days Drinking Alcohol | 2.5 days |
| Usual Care | Change in Days Drinking Alcohol | 8.5 days |
Secondary
Change in Days Drinking Heavily in 30 Days
patients reported number of heavy drinking days in prior 30 days (3 or more standard sized drinks per episode for women and 4 or more standard sized drinks per episode for men), baseline report minus 1 month follow up report
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| mROAD | Change in Days Drinking Heavily in 30 Days | 3 days |
| Usual Care | Change in Days Drinking Heavily in 30 Days | 5.6 days |
Secondary
Change in Motivation to Change Score
Participants reported desire to change via the Change Questionnaire applied to risky alcohol use.\[1\] The Change questionnaire has a Cronbach's alpha of 0.86 when applied to alcohol use.\[2\] Minimum score is 0 (low motivation to change) to maximum 120 (high motivation to change). 1. Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive behaviors. 2008;33(9):1177-1182. 2. Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive Behaviors. 2008;33(9):1177-1182.
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| mROAD | Change in Motivation to Change Score | 7.6 score on a scale |
| Usual Care | Change in Motivation to Change Score | 16.6 score on a scale |
Secondary
Number of Participants Completed Assessment at 1 Month
Feasibility of follow up of urban low-income at risk drinkers by phone defined as number of patients can be contacted at one months to complete assessment of alcohol use
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mROAD | Number of Participants Completed Assessment at 1 Month | 18 Participants |
| Usual Care | Number of Participants Completed Assessment at 1 Month | 13 Participants |