Decisions During Drinking

NCT06978140 | Completed

• 2 other identifiers: STUDY00021311K01AA027771-05
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol

Keywords

alcohol-related consequences

Outcome Measures

Primary Outcomes (3)

• Usability of intervention

  Usability of the intervention is assessed in the intervention group only using a 10-item scale with response options that range from 1 "strongly disagree" to 5 "strongly agree"

  From invitation to the first intervention module to end of modules being available 37 days later

• Acceptability of the intervention

  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".

  From invitation to the first intervention module to end of modules being available 37 days later

• Feasibility of intervention

  Feasibility will be assessed by the percentage of participants randomized to the intervention that complete the intervention and the 1 month follow-up assessment

  From invitation to the first intervention module to the end of the study 2 months later

Secondary Outcomes (2)

• Alcohol consumption

  From completion of baseline survey to 1 month follow-up approximately 67 days later

• Alcohol related consequences

  From completion of baseline survey to 1 month follow-up approximately 67 days later

Study Arms (2)

D3 online health information and text-messages

EXPERIMENTAL

Participants receiver personalized health information feedback across 5-7 online modules over 20-30 days along with text-message health information

Behavioral: Personalized feedback

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

Interventions

Personalized feedback BEHAVIORAL

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.

Also known as: Decisions During Drinking

D3 online health information and text-messages

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Not being able to verify identification

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Center for the Study of Health and Risk Behavior, University of Washington

Seattle, Washington, 98195, United States

Location

Study Officials

• Brittney Hultgren, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: May 18, 2025
• Study Start: April 18, 2025
• Primary Completion: September 10, 2025
• Study Completion: September 10, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be uploaded to the NIAAA by October 2025 and be publicly available by September 2028 (two years after the end of data collection).
• Access Criteria: To access individual level data researchers need to receive authorization by initiating a Data Access Request (DAR), completing the NDA Data Use Certification (DUC) within the DAR, and satisfying several pre-requisites. DARs will be reviewed by a special committee at NIAAA to ensure that the researcher has provided adequate information for the responsible use of the data per the terms of the DUC. https://nda.nih.gov/niaaa/getting-data-access

Locations

US (1)