Alcohol
Conditions
Keywords
alcohol-related consequences
Brief summary
Decisions during drinking (D3) is randomized clinical feasibility trial assessing whether health-related materials created for young adults who want to have more positive experiences if they decide to drink alcohol are acceptable and usable. Enrolled participants will be randomized to receive the health-related messages in 5-7 online modules over the 20-30 days or to only receive assessments. Those randomized to receive the intervention will also receive text-messages with health message content during the 20-30 days. After completing the intervention, participants will report on the usability and acceptability of the material, which is the main outcome. For secondary outcomes, participants in both the intervention and control will report on their drinking and drinking-related consequences in the post-intervention questionnaire (or 30 days after initial questionnaire for control participants) and 1 month later.
Interventions
BEHAVIORALPersonalized feedback
Material includes feedback on alcohol-related consequences with elements from Acceptance Commitment Therapy, Relapse Prevention, Cognitive Behavioral Therapy, and Behavioral Activation. Focus of the intervention is learning about personal environmental cues.
Sponsors
University of Washington
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-24 * At least 1 occurrence of heavy drinking in the past month * At least 2 alcohol related consequences in the past month * Live in Washington State * Agree to be randomized to receive intervention to assessment only control * Ability to receive SMS text-messages * Complete Identification verification
Exclusion criteria
* Not meeting inclusion criteria * Not being able to verify identification
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability of Intervention | From invitation to the first intervention module to end of modules being available 37 days later | Usability of the intervention is assessed in the intervention group only using the System Usability Scale which is a 10-item scale with response options that range from 1 "strongly disagree" to 5 "strongly agree". Total scores were computed using the standard System Usability Scale score ( https://measuringu.com/sus/). Scores can range from 0 to 100. Scores of 68 are seen as average. Higher scores indicate greater usability |
| Acceptability of the Intervention | From invitation to the first intervention module to end of modules being available 37 days later | Acceptability of the intervention is assessed only in the intervention group using a questionnaire of 11 items each of which is participants will provide as response between 1 "Strongly Disagree" to 7 "Strongly Agree". |
| Feasibility of Intervention | From invitation to the first intervention module to the end of the study 2 months later | Feasibility will be assessed by the percentage of participants randomized to the intervention that complete the intervention and the 1 month follow-up assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Consumption | From completion of baseline survey to 1 month follow-up approximately 67 days later | Alcohol consumption will be assessed using the Daily drinking questionnaire, which assesses the number of drinks consumed each day in a typical week in the past month |
| Alcohol Related Consequences | From completion of baseline survey to 1 month follow-up approximately 67 days later | Past month alcohol related consequences will be assessed with 49 questions from several scales including the Rutgers Alcohol Problems Index, Young Adult Alcohol Problems Scale, and the Alcohol-Related Sexual Consequences. All questions except the Alcohol-Related Sexual Consequences are answered on a scale of 0 "Never" to 4 "More than 10 times". Alcohol-Related Sexual Consequences responses are 0 "No" and 1 "Yes" to indicate any occurrence in the past month. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrittney Hultgren, PhD
University of Washington
Participant flow
Recruitment details
Recruitment took place from April 2025 - September 2025 via social media advertisements on Instagram, Facebook, and Reddit. Prior to enrollment participants needed to complete a brief screener and go through an identify verification procedure.
Pre-assignment details
All 35 individuals were randomized
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 21.824 years STANDARD_DEVIATION 1.551 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 11 Participants |
| Total alcohol-related consequences in the past month | 13.313 Number of consequences STANDARD_DEVIATION 5.095 |
| Typical Weekly Number of Drinks | 10.939 Number of Drinks STANDARD_DEVIATION 5.08 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 |
| other Total, other adverse events | 0 / 18 | 0 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 17 |
Outcome results
None listed