Alcohol Consumption
Conditions
Brief summary
This study aims to develop a brief intervention that uses information from a lab-based cue reactivity protocol to create personalized feedback targeting high-risk alcohol use among young adults who drink alcohol. The intervention provides feedback on individuals' drinking desire, mood, willingness to drink, and alcohol demand by comparing scores before and after viewing and smelling an alcoholic beverage in the lab session. 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 is used in a randomized controlled trial (RCT) comparing young adults who receive the brief, online intervention to those who did not receive the brief, online intervention. Participants in both groups complete baseline, lab-based cue reactivity protocol, 2-week follow-up and 3-month follow-up.
Detailed description
The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' responses from a baseline survey and from a lab-based cue reactivity protocol. The aim of the intervention is to increase young adults' awareness of how alcohol cues may affect their desire to drink, mood, willingness to drink, and alcohol demand both in relation to lab-based exposure to an alcohol beverage of their choice and also more broadly in everyday life. 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 assessments and lab protocol but do not receive any personalized feedback. Online assessments include an eligibility survey, baseline assessment, and follow-up assessments occurring 2-weeks and 3-months post-intervention. Everyone has one in-person session to complete the lab-based cue reactivity protocol after the baseline assessment has been completed online. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.
Interventions
BEHAVIORALLab-based Cue Reactivity Personalized Feedback Intervention (PFI)
This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
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: (1) Personalized feedback based on reports from baseline and lab-session and (2) assessment-only control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Between ages 18-24 * Lives in Washington state * Reports drinking at least two days per week in the last six months * Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month * Open to changing drinking behavior * Must be willing to come to our Seattle study office for session visit * Provide an email address and phone number for study communication
Exclusion criteria
* Actively seeking treatment for alcohol use * 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. |
| Heavy Episodic Drinking | 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. Higher values represent a worse outcome (i.e., more consequences). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Washington state (e.g., via Instagram). 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 (i.e., posting ads on social media) went from April 2023 to December 2023. Participant enrollment (i.e., completion of lab session) went from May 2023 to December 2023.
Participants by arm
| Arm | Count |
|---|---|
| Assessment-only Control Participants randomized to the control group will not receive any intervention. They complete all the survey assessments and the lab-based cue reactivity protocol without ever receiving any personalized feedback. | 42 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) Participants randomized to the Lab-based Cue Reactivity PFI condition will receive a link to the personalized feedback in the lab after completing the cue reactivity protocol. Participants view the feedback on their own during the lab session. The personalized feedback is delivered online and contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
Lab-based Cue Reactivity Personalized Feedback Intervention (PFI): This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure. | 51 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
Baseline characteristics
| Characteristic | Assessment-only Control | Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Total |
|---|---|---|---|
| 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 | 42 Participants | 51 Participants | 93 Participants |
| Age, Continuous | 21.93 years STANDARD_DEVIATION 1.66 | 21.04 years STANDARD_DEVIATION 1.87 | 21.44 years STANDARD_DEVIATION 1.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 9 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 42 Participants | 78 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 | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 5 Participants | 9 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 | 26 Participants | 35 Participants | 61 Participants |
| Region of Enrollment United States | 42 participants | 51 participants | 93 participants |
| Sex: Female, Male Female | 22 Participants | 30 Participants | 52 Participants |
| Sex: Female, Male Male | 20 Participants | 21 Participants | 41 Participants |
| Student Status 4-year student | 21 Participants | 30 Participants | 51 Participants |
| Student Status Not a 4-year student | 21 Participants | 21 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 51 |
| other Total, other adverse events | 0 / 42 | 0 / 51 |
| serious Total, serious adverse events | 0 / 42 | 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. Higher values represent a worse outcome (i.e., more consequences).
Time frame: Baseline, 2 week follow-up, and 3 month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | Baseline | 8.74 Score on a scale | Standard Deviation 5.18 |
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | 2-Week Follow-Up | 4.88 Score on a scale | Standard Deviation 4.8 |
| Assessment-only Control | Brief Young Adult Alcohol Consequences Questionnaire | 3-Month Follow-Up | 6.11 Score on a scale | Standard Deviation 5.26 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Brief Young Adult Alcohol Consequences Questionnaire | 3-Month Follow-Up | 7.06 Score on a scale | Standard Deviation 5.37 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Brief Young Adult Alcohol Consequences Questionnaire | Baseline | 9.92 Score on a scale | Standard Deviation 5.02 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Brief Young Adult Alcohol Consequences Questionnaire | 2-Week Follow-Up | 5.78 Score on a scale | Standard Deviation 5.11 |
Comparison: Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.p-value: 0.6695% CI: [0.76, 1.54]Generalized linear mixed model
Comparison: Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.p-value: 0.9295% CI: [0.75, 1.38]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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Daily Drinking Questionnaire | Baseline | 10.24 Drinks per week | Standard Deviation 5.16 |
| Assessment-only Control | Daily Drinking Questionnaire | 2-Week Follow-Up | 8.79 Drinks per week | Standard Deviation 7.25 |
| Assessment-only Control | Daily Drinking Questionnaire | 3-Month Follow-Up | 6.97 Drinks per week | Standard Deviation 5.46 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Daily Drinking Questionnaire | Baseline | 12.27 Drinks per week | Standard Deviation 7.95 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Daily Drinking Questionnaire | 2-Week Follow-Up | 9.73 Drinks per week | Standard Deviation 6.95 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Daily Drinking Questionnaire | 3-Month Follow-Up | 9.14 Drinks per week | Standard Deviation 7.7 |
Comparison: Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.p-value: 0.8395% CI: [0.74, 1.27]Generalized linear mixed model
Comparison: Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.p-value: 0.6195% CI: [0.83, 1.38]Generalized linear mixed model
Primary
Heavy Episodic Drinking
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Heavy Episodic Drinking | Baseline | 2.45 Heavy Drinking Occasions | Standard Deviation 1.92 |
| Assessment-only Control | Heavy Episodic Drinking | 2-Week Follow-Up | 1.86 Heavy Drinking Occasions | Standard Deviation 1.78 |
| Assessment-only Control | Heavy Episodic Drinking | 3-Month Follow-Up | 1.53 Heavy Drinking Occasions | Standard Deviation 1.37 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Heavy Episodic Drinking | Baseline | 2.47 Heavy Drinking Occasions | Standard Deviation 2.17 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Heavy Episodic Drinking | 2-Week Follow-Up | 2.18 Heavy Drinking Occasions | Standard Deviation 1.75 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Heavy Episodic Drinking | 3-Month Follow-Up | 1.86 Heavy Drinking Occasions | Standard Deviation 1.95 |
Comparison: Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.p-value: 0.4595% CI: [0.79, 1.72]Generalized linear mixed model
Comparison: Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.p-value: 0.4695% CI: [0.77, 1.79]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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Assessment-only Control | Penn Alcohol Craving Scale | Baseline | 6.93 Score on a scale | Standard Deviation 3.96 |
| Assessment-only Control | Penn Alcohol Craving Scale | 2-Week Follow-Up | 7.31 Score on a scale | Standard Deviation 4.81 |
| Assessment-only Control | Penn Alcohol Craving Scale | 3-Month Follow-Up | 5.74 Score on a scale | Standard Deviation 4.23 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Penn Alcohol Craving Scale | Baseline | 8.04 Score on a scale | Standard Deviation 4.11 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Penn Alcohol Craving Scale | 2-Week Follow-Up | 8.04 Score on a scale | Standard Deviation 5.44 |
| Lab-based Cue Reactivity Personalized Feedback Intervention (PFI) | Penn Alcohol Craving Scale | 3-Month Follow-Up | 7.24 Score on a scale | Standard Deviation 5.09 |
Comparison: Changes from Baseline to 2-Week Follow-Up for PFI versus AOC reported in this section.p-value: 0.6295% CI: [0.77, 1.17]Generalized linear mixed model
Comparison: Changes from Baseline to 3-Month Follow-Up for PFI versus AOC reported in this section.p-value: 0.3495% CI: [0.87, 1.48]Generalized linear mixed model