NCT03889873

Brief Summary

The purpose of the proposed research is to evaluate whether changes in drinking identity (DI; how much one associates one's self with drinking) can reduce hazardous drinking (HD; heavy alcohol use and negative alcohol-related consequences) among current college students. The study seeks to explore whether manipulating DI among participants will have changes in self-efficacy, craving, and HD. If such an effect can be found, DI may be a mechanism for HD behavior change and will allow researchers to develop and improve interventions aimed at HD behaviors in high-risk young adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

April 18, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

March 14, 2019

Last Update Submit

September 30, 2021

Conditions

Keywords

Drinking identityHazardous drinkingSocial networksSelf-efficacyAlcohol cravingCognitive controlNarrative writing

Outcome Measures

Primary Outcomes (8)

  • Changes in Implicit Drinking identity

    drinking identity implicit association test (IAT)

    will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)

  • Changes in Explicit Drinking identity

    Alcohol Self-concept Scale; item responses range from -3 to +3; average score on all items is calculated; lower scores represent a better outcome

    will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)

  • changes in self-efficacy

    drinking refusal self-efficacy questionnaire

    will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)

  • cue-related craving

    current craving from cue reactivity task; assessed via alcohol urge questionnaire

    Cue related craving will be assessed following the cue reactivity task, which occurs during the third and final lab-based session (technically, the third week of the study)

  • changes in past week craving

    Penn Alcohol Craving Scale; item responses range from 0 to 6; total score on all items is calculated (can range from 0 to 30); lower scores = better outcome

    will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)

  • changes in alcohol consumption

    Modified timeline follow back will assess past daily alcohol consumption (# standard drinks per day); higher consumption = worse outcomes

    will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)

  • changes in last 3 month alcohol problems

    Rutgers Alcohol Problems Inventory (RAPI) will be used to assess alcohol problems; item response options range from 0 to 4; total score ranges from 0 to 100; higher scores = worse outcomes

    Assessed at lab 1 (week1) and 3-month follow up; data will be reported through study completion (3 month follow up)

  • changes in last two week alcohol problems

    adapted from RAPI \& Young Adult Alcohol Problems Screening Test (YAAPST); item responses are 0 (did not happen) or 1 (happened); higher scores (range from 0 to 10) = worse outcomes

    assessed at lab 2 and 3 (weeks 2 and 3) and at 2 week and 1 month follow up; data will be reported through 1 month follow up

Secondary Outcomes (4)

  • changes in future drinking intentions

    assessed at lab 1, lab 2, lab 3 (weeks 1-3); data will be reported through week 3

  • changes in frequency of heavy & extreme binge drinking

    assessed at lab 1 (week 1) &

  • Changes in Readiness to Change Drinking

    post-writing (lab 1, lab 2, lab 3) long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)

  • Changes in single-item assessing self-efficacy to limit one's drinking

    will be assessed at lab 1, lab 2, lab 2 (weeks 1-3) & long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)

Other Outcomes (7)

  • Changes in social network composition

    will be assessed at baseline and 3-month follow up; data will be reported through study completion (3 month follow up)

  • Changes in desire thinking about alcohol

    assessed at lab 1 (week 1) and long-term follow up (2-week, 1 month, 3 month); data will be reported through study completion (3 month follow up)

  • Changes in smartphone addiction proneness

    Assessed at lab 1 (week 1) and long-term follow up (2 week, 1 month, 3 month); data will be reported through study completion (3 month follow up)

  • +4 more other outcomes

Study Arms (8)

Drinking; No network; First-person

EXPERIMENTAL

In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using first-person pronouns.

Behavioral: Narrative Writing

Drinking; Network; First-person

EXPERIMENTAL

In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using first-person pronouns.

Behavioral: Narrative Writing

Drinking; No network; Third-person

EXPERIMENTAL

In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using third-person pronouns.

Behavioral: Narrative Writing

Drinking; Network; Third-person

EXPERIMENTAL

In this narrative writing task, the participant is asked to imagine him/herself as a low-risk drinker and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using third-person pronouns.

Behavioral: Narrative Writing

Smartphone; No network; First-person

EXPERIMENTAL

In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using first-person pronouns.

Behavioral: Narrative Writing

Smartphone; Network; First-person

EXPERIMENTAL

In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using first-person pronouns.

Behavioral: Narrative Writing

Smartphone; No network; Third-person

EXPERIMENTAL

In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt does not instruct to write about social network (important people, friends, family); participant will write using third-person pronouns.

Behavioral: Narrative Writing

Smartphone; Network; Third-person

EXPERIMENTAL

In this narrative writing task, the participant is asked to imagine him/herself as someone who has reduced their smartphone usage and describe this future self; the prompt instructions include writing about social network (important people, friends, family); participant will write using third-person pronouns.

Behavioral: Narrative Writing

Interventions

An writing task in which participants are given a description of a possible future self (that varies 3 factors: topic; drinking vs. smartphone; perspective: 1st vs. 3rd-person; and social network: specifically asked to be included vs. not specifically asked to be included). Participants are asked to imagine that future self vividly and to write about the thoughts and feeling describe themselves and their experiences, the characteristics they hope or wish they will ideally possess, the characteristics that they would need to have and the roles they will take on or things they will be doing. Participants are given 20 minutes to think and write. They will write and think about the same future on each of three lab-sessions (which occur at 1-week intervals).

Drinking; Network; First-personDrinking; Network; Third-personDrinking; No network; First-personDrinking; No network; Third-personSmartphone; Network; First-personSmartphone; Network; Third-personSmartphone; No network; First-personSmartphone; No network; Third-person

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must be full-time UW students, fluent in the English language, and recent (past week) drinkers who self-report drinking hazardously (i.e., score an 8 or above on the Alcohol Use Disorder Identification Test, AUDIT). Participants must also own a smartphone.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

HabitsSocial Identification

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Officials

  • Kristen P Lindgren, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The PI, the project coordinator, and experimenters will not know which participants have been assigned to each condition. Outcomes are assessed via computer/online survey. There is no human outcome assessor in this study.
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: Participants are randomly assigned to a condition to receive one of eight writing prompt variants in a 2x2x2 study design. There is also a within subjects component as participants complete the same writing prompt 3 times (once per week over a 3-week period).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Medicine: Psychiatry

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 26, 2019

Study Start

April 18, 2019

Primary Completion

February 26, 2021

Study Completion

June 7, 2021

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

We will share responses to questionnaires and writing exercises with co-investigators. We do not currently have plans to store data in a repository/database (for example, via the Open Science Framework \[OSF\] - https://osf.io/), though we may ultimately do so should this be a condition of publishing in a scientific journal or necessary for other unforeseen reasons. Should we do so, we would not publish or make available or the narrative writing responses verbatim. Similarly, we would also not publish or make available the variables that describe the 10 most important people on the important people measure. No direct identifiers will be included in any data shared.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Data will become available after the grant period of award is completed unless there is a requirement to make data publicly available as a condition of publication.
Access Criteria
Data access requests will be reviewed by the PI and study research coordinator. Requestors will be required to sign a data use agreement.

Locations