Alcohol Drinking, Problem Drinking
Conditions
Keywords
Alcohol, Intervention, Young Adults, Personalized Feedback
Brief summary
This study aims to develop a brief intervention that incorporates ecological momentary assessments (EMAs; i.e., four brief surveys per day for 17 days) to create personalized feedback targeting high-risk alcohol use among young adult drinkers. The intervention mainly focuses on providing feedback on individuals' drinking desire and how it varies as a function of a number of real-world factors. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention will be used in a randomized controlled trial (RCT) comparing young adults who receive the intervention with those who only complete identical assessments.
Detailed description
The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' own event-level, real-world experiences. The aim of the intervention is to increase young adults' awareness of their desire to drink as it varies as a function of a number of real-world factors including alcohol cues, social context, physical context, anticipation of later drinking, mood, and time of day. The intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking. This brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the EMAs but do not receive any personalized feedback. Assessments include an eligibility survey, baseline assessment, 17 days of EMAs (4x/day), and follow-up assessments occurring 2-weeks and 3-months post-intervention. The 2-week and 3-month follow-ups occurred 2-weeks and 3-months, respectively, from Day 17 of the EMA period, because the intervention was delivered on Day 17. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.
Interventions
BEHAVIORALAlcohol Cue Reactivity Personalized Feedback Intervention
This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to one of two conditions (Personalized feedback and assessment-only control group).
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\) Between ages 18-24, 2) Lives in Washington state, 3) Reports drinking at least two days per week in the last six months, 4) Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month, 5) Open to changing drinking behavior, 6) Schedule allows for participation in study with daily surveys, 7) Able to attend Zoom training session, 8) Must have cellphone for daily surveys.
Exclusion criteria
* 1\) Actively seeking treatment for alcohol use, 2) Currently participating in another study in our research center regarding young adult drinking behavior.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Drinking Questionnaire | Baseline, 2 week follow-up, and 3 month follow-up | Number of standard drinks consumed on each day of a typical week during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week. |
| Number of Heavy Episodic Drinking Occasions | Baseline, 2 week follow-up, and 3 month follow-up | Participants were asked, During the past two weeks, how many times did you have \[4/5 for females/males\] or more drinks at one sitting?. Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10. |
| Penn Alcohol Craving Scale | Baseline, 2 week follow-up, and 3 month follow-up | Self-reported subjective alcohol craving during the past week. Response options were scored from 0 to 6 with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving. |
| Brief Young Adult Alcohol Consequences Questionnaire | Baseline, 2 week follow-up, and 3 month follow-up | Participants responded no (0) or yes (1) to whether they experienced each of 24 consequences during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Washington state using a variety of recruitment methods (e.g., predominantly Instagram, random selection of students from university registrar's lists). Individuals were invited to complete an online eligibility survey for participation in a randomized clinical trial to test the effect of an online personalized feedback intervention. Recruitment/enrollment period went from April 2022 to January 2023.
Participants by arm
| Arm | Count |
|---|---|
| Assessment-only Control Participants randomized to the control group will not receive any intervention. They will be an assessment-only control group. | 48 |
| Cue Reactivity Personalized Feedback Intervention (PFI) Participants randomized to the Cue Reactivity PFI condition will receive personalized feedback at the end of completing 17 days of ecological momentary assessments (EMAs) four times a day. The personalized feedback will be delivered online and contains information summarizing participants' desire to drink as it varied as a function of several real-world factors across the 17-day EMA period.
Alcohol Cue Reactivity Personalized Feedback Intervention: This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults. | 51 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | Assessment-only Control | Total | Cue Reactivity Personalized Feedback Intervention (PFI) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 99 Participants | 51 Participants |
| Age, Continuous | 21.42 years STANDARD_DEVIATION 1.75 | 21.56 years STANDARD_DEVIATION 1.8 | 21.69 years STANDARD_DEVIATION 1.86 |
| Current educational status 4-year student | 27 Participants | 55 Participants | 28 Participants |
| Current educational status Not a 4-year student | 21 Participants | 44 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 7 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 92 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 17 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 30 Participants | 64 Participants | 34 Participants |
| Region of Enrollment United States | 48 participants | 99 participants | 51 participants |
| Sex: Female, Male Female | 26 Participants | 54 Participants | 28 Participants |
| Sex: Female, Male Male | 22 Participants | 45 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 51 |
| other Total, other adverse events | 0 / 48 | 0 / 51 |
| serious Total, serious adverse events | 0 / 48 | 0 / 51 |
Outcome results
Primary
Brief Young Adult Alcohol Consequences Questionnaire
Participants responded no (0) or yes (1) to whether they experienced each of 24 consequences during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. A sum of the number of negative alcohol-related consequences was calculated and the possible range was 0-24.
Time frame: Baseline, 2 week follow-up, and 3 month follow-up
Population: Young adults
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | Baseline | 7.81 Number of consequences (range 0-24) | Standard Deviation 5.02 |
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | 2-Week Follow-Up | 4.78 Number of consequences (range 0-24) | Standard Deviation 4.35 |
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | 3-Month Follow-Up | 6.37 Number of consequences (range 0-24) | Standard Deviation 5.65 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Brief Young Adult Alcohol Consequences Questionnaire | Baseline | 8.78 Number of consequences (range 0-24) | Standard Deviation 4.13 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Brief Young Adult Alcohol Consequences Questionnaire | 2-Week Follow-Up | 4.52 Number of consequences (range 0-24) | Standard Deviation 3.61 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Brief Young Adult Alcohol Consequences Questionnaire | 3-Month Follow-Up | 6.04 Number of consequences (range 0-24) | Standard Deviation 5.12 |
Comparison: Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.p-value: 0.1195% CI: [0.66, 1.04]Generalized linear mixed model
Comparison: Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.p-value: 0.3895% CI: [0.66, 1.17]Generalized linear mixed model
Primary
Daily Drinking Questionnaire
Number of standard drinks consumed on each day of a typical week during the \[past 3 months for baseline and 3-month follow-up; past two weeks for 2-week follow-up\]. Participants responded on a scale from 0 (0 drinks) to 25 (25 or more drinks). Totals for each day are summed to calculate the typical number of drinks consumed per week.
Time frame: Baseline, 2 week follow-up, and 3 month follow-up
Population: Young adults
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Daily Drinking Questionnaire | Baseline | 12.23 Drinks per week | Standard Deviation 11.85 |
| Assessment-only Control | Daily Drinking Questionnaire | 2-Week Follow-Up | 10.31 Drinks per week | Standard Deviation 10.77 |
| Assessment-only Control | Daily Drinking Questionnaire | 3-Month Follow-Up | 7.54 Drinks per week | Standard Deviation 7.16 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Daily Drinking Questionnaire | Baseline | 11.78 Drinks per week | Standard Deviation 7.24 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Daily Drinking Questionnaire | 2-Week Follow-Up | 9.40 Drinks per week | Standard Deviation 6.28 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Daily Drinking Questionnaire | 3-Month Follow-Up | 8.49 Drinks per week | Standard Deviation 7.16 |
Comparison: Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.p-value: 0.6895% CI: [0.76, 1.2]Generalized linear mixed model
Comparison: Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.p-value: 0.5695% CI: [0.81, 1.49]Generalized linear mixed model
Primary
Number of Heavy Episodic Drinking Occasions
Participants were asked, During the past two weeks, how many times did you have \[4/5 for females/males\] or more drinks at one sitting?. Participants responded on a scale from 0 (0 times) to 10 (10 or more times) and possible range was 0-10.
Time frame: Baseline, 2 week follow-up, and 3 month follow-up
Population: Young adults
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Number of Heavy Episodic Drinking Occasions | Baseline | 2.46 Number heavy episodic drinking occasions | Standard Deviation 2.32 |
| Assessment-only Control | Number of Heavy Episodic Drinking Occasions | 2-Week Follow-Up | 2.46 Number heavy episodic drinking occasions | Standard Deviation 2.1 |
| Assessment-only Control | Number of Heavy Episodic Drinking Occasions | 3-Month Follow-Up | 1.63 Number heavy episodic drinking occasions | Standard Deviation 1.82 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Number of Heavy Episodic Drinking Occasions | Baseline | 2.43 Number heavy episodic drinking occasions | Standard Deviation 1.97 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Number of Heavy Episodic Drinking Occasions | 2-Week Follow-Up | 2.28 Number heavy episodic drinking occasions | Standard Deviation 1.72 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Number of Heavy Episodic Drinking Occasions | 3-Month Follow-Up | 1.98 Number heavy episodic drinking occasions | Standard Deviation 1.93 |
Comparison: Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.p-value: 0.6895% CI: [0.64, 1.33]Generalized linear mixed model
Comparison: Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.p-value: 0.395% CI: [0.82, 1.88]Generalized linear mixed model
Primary
Penn Alcohol Craving Scale
Self-reported subjective alcohol craving during the past week. Response options were scored from 0 to 6 with text varying across items. A sum score of the five items was calculated and the possible range was from 0-30. Higher scores reflect more craving.
Time frame: Baseline, 2 week follow-up, and 3 month follow-up
Population: Young adults
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Penn Alcohol Craving Scale | Baseline | 6.58 Score on a scale | Standard Deviation 5.12 |
| Assessment-only Control | Penn Alcohol Craving Scale | 2-Week Follow-Up | 7.80 Score on a scale | Standard Deviation 4.55 |
| Assessment-only Control | Penn Alcohol Craving Scale | 3-Month Follow-Up | 5.80 Score on a scale | Standard Deviation 4.28 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Penn Alcohol Craving Scale | Baseline | 7.92 Score on a scale | Standard Deviation 5.07 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Penn Alcohol Craving Scale | 2-Week Follow-Up | 8.66 Score on a scale | Standard Deviation 5.81 |
| Cue Reactivity Personalized Feedback Intervention (PFI) | Penn Alcohol Craving Scale | 3-Month Follow-Up | 7.46 Score on a scale | Standard Deviation 5.01 |
Comparison: Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.p-value: 0.3695% CI: [0.69, 1.15]Generalized linear mixed model
Comparison: Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.p-value: 0.7395% CI: [0.8, 1.38]Generalized linear mixed model