Decisions During Drinking

NCT06978140 — Not applicable, Completed, 35 participants, University of Washington

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Decisions During Drinking: Phase 3 Feasibility Study

Registry	NCT06978140, acronym D3
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	35 (Actual)
Sponsor	University of Washington (Other); collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions	Alcohol
Interventions	Personalized feedback (Behavioral)
Dates	start 2025-04-18, primary completion 2025-09-10, completion 2025-09-10, first posted 2025-05-18, last updated 2026-10-08
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
D3 online health information and text-messages	Experimental	Behavioral: Personalized feedback	Participants receiver personalized health information feedback across 5-7 online modules over 20-30 days along with text-message health information
Assessment only control	No intervention		Participants will receive questionnaires similar to intervention group but will not receive any health information modules or related text-messages

Personalized feedback (Behavioral), also known as Decisions During Drinking: 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.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 24 Years

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

+Posted results

Participant flow

Milestone	D3 Online Health Information and Text-messages	Assessment Only Control
Started	18	17
Post assessment	16	17
One-month follow up	16	17
Completed	13	13
Not completed	5	4

Outcome results

Usability of Intervention (Primary), Mean, Scores on a scale: D3 Online Health Information and Text-messages 66.33 +/- 15.49
Acceptability of the Intervention (Primary), Mean, score on a scale: D3 Online Health Information and Text-messages 4.80 +/- 1.74
Feasibility of Intervention (Primary), Count of participants, Participants: D3 Online Health Information and Text-messages 14
Alcohol Consumption (Secondary), Mean, drinks: D3 Online Health Information and Text-messages 8.538 +/- 6.437; Assessment Only Control 8.154 +/- 6.437
Alcohol Related Consequences (Secondary), Mean, consequences: D3 Online Health Information and Text-messages 8.00 +/- 7.257; Assessment Only Control 10.462 +/- 7.183

Adverse events

Time frame: From enrollment to end of follow up, about 67 days

Arm	Deaths	Serious adverse events	Other adverse events
D3 Online Health Information and Text-messages	0/18 (0.0%)	0/18 (0.0%)	0/18 (0.0%)
Assessment Only Control	0/17 (0.0%)	0/17 (0.0%)	0/17 (0.0%)

Limitations and caveats: The small sample size limits the generalizability of findings and reduces the ability to detect significant effects. As a self-guided, online intervention, engagement likely varied based on participant motivation and day-to-day circumstances, which may have influenced how consistently participants completed modules and engaged with the material. We limited access to view the intervention material for up to 1 month.

+Locations (1)

Facility	City	Country	Status
Center for the Study of Health and Risk Behavior, University of Washington	Seattle, Washington	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2026-09-14)

+Investigators

Brittney Hultgren, PhD, Principal investigator, University of Washington

+Funding

NIH grants: K01AA027771