Alcohol Consumption
Conditions
Brief summary
A 5-arm randomized trial to determine what components of a text message intervention are necessary to reduce hazardous drinking among young adults and mechanisms through which these changes occur.
Detailed description
Young adults ages 18-25 have high rates of hazardous alcohol use and alcohol-related consequences. The Emergency Department (ED) provides an important opportunity to identify young adult hazardous drinkers who could benefit from interventions. A Text Message (TM) intervention was shown to reduce alcohol consumption among young adult ED patients, showing durable effects over 9-months. The TM intervention uses behavior change techniques with the largest effect sizes in an alcohol intervention meta-analysis: goal commitment and self-monitoring, along with real-time feedback. However, the unique effect of these ingredients, and mechanisms (processes occurring within the individual) through which they operate to reduce drinking remain unclear, a critical gap addressed by this project. Young adult ED patients (ages 18-25) who screen positive for hazardous drinking will be recruited to participate in a randomized trial to determine how best to help individuals reduce hazardous drinking. All participants will be asked to complete web-based surveys at baseline, 12 and 24 weeks after enrollment, complete brief psychomotor tasks weekly for 14 weeks, and respond to text messages each Thursday and Sunday for the next 12 weeks. Those randomized to the TM interventions will additionally receive feedback on their text reports. The four TM intervention arms are: (1) Drinking Cognition Feedback (DCF), (2) Alcohol Risk Feedback (ARF), (3) Adaptive Goal Support (AGS) and (4) a combination of DCF, ARF, and AGS=COMBO). Study results have implications for designing efficient mobile interventions, and developing a dynamic theory of behavior change.
Interventions
BEHAVIORALDrinking Cognition Feedback (DCF)
12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).
BEHAVIORALAlcohol Risk Feedback (ARF)
12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend).
BEHAVIORALAdaptive Goal Support (AGS)
12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).
BEHAVIORALCOMBO
12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* total score of \>2 for women or \>3 for men on the AUDIT-C * at least 1 binged drinking episode in the prior 30 days
Exclusion criteria
* no cell phone with text messaging * have been diagnosed with an alcohol or substance use disorder * pregnant or planning pregnancy * taking medicine for a psychiatric disorder (including depression, anxiety) * taking any medicine that could interact with alcohol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Binge Drinking Days | 12 weeks after starting intervention | Measured by the # days on the Timeline Followback Calendar that a male reported 5+ drinks or a female reported 4+ drinks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drinks Per Drinking Day | 12 weeks after starting intervention | drinks per drinking day = mean drinks divided by the number of days with any alcohol consumption using the 30-day TLFB Calendar. |
| Count of Participants With Any Binge Drinking Day | 12 weeks after starting intervention | Using the Timeline Followback Calendar, any male participant reported one or more days with 5+ drinks or a female with one or more days with 4+ drinks are coded=1; otherwise participant is coded=0 |
| Brief Young Adult Alcohol Consequences Questionnaire Score | 12 weeks after starting intervention | Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ). The B-YAACQ is a 24-item measure of alcohol- related problems that utilizes a dichotomous (present or absent) scoring format. Sum of items 1-48. Higher scores (count of items marked as 'present') on the B-YAACQ not only indicate a wider variety but also reflect a more severe pattern of alcohol-related problems. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COMBO 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.
COMBO: 12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS. | 220 |
| Adaptive Goal Support (AGS) 12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).
Adaptive Goal Support (AGS): 12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed). | 213 |
| Alcohol Risk Feedback (ARF) 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend).
Alcohol Risk Feedback (ARF): 12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend). | 232 |
| Drinking Cognition Feedback (DCF) 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).
Drinking Cognition Feedback (DCF): 12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk). | 224 |
| Control 12 weeks of text message assessments without any feedback | 242 |
| Total | 1,131 |
Baseline characteristics
| Characteristic | COMBO | Total | Control | Drinking Cognition Feedback (DCF) | Alcohol Risk Feedback (ARF) | Adaptive Goal Support (AGS) |
|---|---|---|---|---|---|---|
| Age, Continuous | 21.8 years STANDARD_DEVIATION 2.2 | 22.1 years STANDARD_DEVIATION 2.1 | 22.1 years STANDARD_DEVIATION 2 | 22.3 years STANDARD_DEVIATION 2.1 | 22.1 years STANDARD_DEVIATION 2.1 | 22.2 years STANDARD_DEVIATION 2 |
| Any tobacco use | 123 participants | 582 participants | 105 participants | 117 participants | 120 participants | 117 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 97 Participants | 28 Participants | 14 Participants | 17 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 201 Participants | 1034 Participants | 214 Participants | 210 Participants | 215 Participants | 194 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Impulsivity score | 41.4 units on a scale STANDARD_DEVIATION 7.4 | 41.5 units on a scale STANDARD_DEVIATION 7.1 | 41.4 units on a scale STANDARD_DEVIATION 7.7 | 41.3 units on a scale STANDARD_DEVIATION 6.9 | 41.3 units on a scale STANDARD_DEVIATION 6.9 | 41.9 units on a scale STANDARD_DEVIATION 6.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 10 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 420 Participants | 95 Participants | 86 Participants | 82 Participants | 81 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 61 Participants | 14 Participants | 9 Participants | 11 Participants | 14 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 31 Participants | 7 Participants | 6 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 116 Participants | 609 Participants | 126 Participants | 123 Participants | 132 Participants | 112 Participants |
| Sex: Female, Male Female | 145 Participants | 775 Participants | 168 Participants | 156 Participants | 163 Participants | 143 Participants |
| Sex: Female, Male Male | 75 Participants | 356 Participants | 74 Participants | 68 Participants | 69 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 220 | 0 / 213 | 0 / 232 | 0 / 224 | 0 / 242 |
| other Total, other adverse events | 0 / 220 | 0 / 213 | 0 / 232 | 0 / 224 | 0 / 242 |
| serious Total, serious adverse events | 0 / 220 | 0 / 213 | 0 / 232 | 0 / 224 | 0 / 242 |
Outcome results
Primary
Number of Binge Drinking Days
Measured by the # days on the Timeline Followback Calendar that a male reported 5+ drinks or a female reported 4+ drinks
Time frame: 12 weeks after starting intervention
Population: CCA
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COMBO | Number of Binge Drinking Days | 2.3 days | Standard Deviation 3.3 |
| Adaptive Goal Support (AGS) | Number of Binge Drinking Days | 2.6 days | Standard Deviation 4.2 |
| Alcohol Risk Feedback (ARF) | Number of Binge Drinking Days | 2.9 days | Standard Deviation 4.3 |
| Drinking Cognition Feedback (DCF) | Number of Binge Drinking Days | 3.0 days | Standard Deviation 4.3 |
| Control | Number of Binge Drinking Days | 3.4 days | Standard Deviation 4.2 |
Secondary
Brief Young Adult Alcohol Consequences Questionnaire Score
Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ). The B-YAACQ is a 24-item measure of alcohol- related problems that utilizes a dichotomous (present or absent) scoring format. Sum of items 1-48. Higher scores (count of items marked as 'present') on the B-YAACQ not only indicate a wider variety but also reflect a more severe pattern of alcohol-related problems.
Time frame: 12 weeks after starting intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COMBO | Brief Young Adult Alcohol Consequences Questionnaire Score | 4.1 score on a scale | Standard Deviation 4.7 |
| Adaptive Goal Support (AGS) | Brief Young Adult Alcohol Consequences Questionnaire Score | 4.4 score on a scale | Standard Deviation 5.1 |
| Alcohol Risk Feedback (ARF) | Brief Young Adult Alcohol Consequences Questionnaire Score | 5.0 score on a scale | Standard Deviation 5.1 |
| Drinking Cognition Feedback (DCF) | Brief Young Adult Alcohol Consequences Questionnaire Score | 4.7 score on a scale | Standard Deviation 5.3 |
| Control | Brief Young Adult Alcohol Consequences Questionnaire Score | 5.6 score on a scale | Standard Deviation 5.5 |
Secondary
Count of Participants With Any Binge Drinking Day
Using the Timeline Followback Calendar, any male participant reported one or more days with 5+ drinks or a female with one or more days with 4+ drinks are coded=1; otherwise participant is coded=0
Time frame: 12 weeks after starting intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COMBO | Count of Participants With Any Binge Drinking Day | 95 Participants |
| Adaptive Goal Support (AGS) | Count of Participants With Any Binge Drinking Day | 110 Participants |
| Alcohol Risk Feedback (ARF) | Count of Participants With Any Binge Drinking Day | 119 Participants |
| Drinking Cognition Feedback (DCF) | Count of Participants With Any Binge Drinking Day | 115 Participants |
| Control | Count of Participants With Any Binge Drinking Day | 144 Participants |
Secondary
Drinks Per Drinking Day
drinks per drinking day = mean drinks divided by the number of days with any alcohol consumption using the 30-day TLFB Calendar.
Time frame: 12 weeks after starting intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COMBO | Drinks Per Drinking Day | 2.9 drinks/day | Standard Deviation 2.5 |
| Adaptive Goal Support (AGS) | Drinks Per Drinking Day | 2.9 drinks/day | Standard Deviation 2 |
| Alcohol Risk Feedback (ARF) | Drinks Per Drinking Day | 3.2 drinks/day | Standard Deviation 2.1 |
| Drinking Cognition Feedback (DCF) | Drinks Per Drinking Day | 3.0 drinks/day | Standard Deviation 2.2 |
| Control | Drinks Per Drinking Day | 3.5 drinks/day | Standard Deviation 2.2 |