NCT04052386

Brief Summary

The present study focuses on examining the feasibility, acceptability, and preliminary effects of an adapted alcohol intervention for high-risk college students attending community colleges. Investigators adapted BASICS (an efficacious in-person intervention developed for high-risk drinkers attending 4-year colleges and universities) to a web-conferencing format that allows the facilitator and participant to see and discuss live web-based personalized feedback. SMS text messages with protective behavioral strategies were also provided. The objective of the R34 was to establish feasibility and acceptability as well as to determine preliminary or likely effect sizes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

August 7, 2019

Last Update Submit

August 8, 2019

Conditions

Outcome Measures

Primary Outcomes (8)

  • Daily Drinking Questionnaire

    Number of standard drinks consumed each day of typical week past month

    1-month

  • Daily Drinking Questionnaire

    Number of standard drinks consumed each day of typical week past month

    3-month

  • Frequency of Binge Drinking

    Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)

    1-month

  • Frequency of Binge Drinking

    Number of times in past month engaged in heavy episodic drinking (4+ drinks for women, 5+ drinks for men)

    3-month

  • Estimated Blood Alcohol Concentration (eBAC)

    estimated peak blood alcohol concentration

    1-month

  • Estimated Blood Alcohol Concentration (eBAC)

    estimated peak blood alcohol concentration

    3-month

  • Brief Young Adult Alcohol Consequences Questionnaire

    Number of alcohol-related consequences endorsed

    1-month

  • Brief Young Adult Alcohol Consequences Questionnaire

    Number of alcohol-related consequences endorsed

    3-month

Study Arms (2)

BASICCS

EXPERIMENTAL

Participants randomized to the BASICCS condition received a personalized feedback intervention conducted through a web-conferencing platform. They also received up to 24 text messages with protective behavioral strategies for drinking during the following month.

Behavioral: BASICCS

Control

NO INTERVENTION

Participants randomized to the control group did not receive any intervention. They were an assessment-only control group.

Interventions

BASICCSBEHAVIORAL

Participants randomized to the BASICCS condition received a personalized feedback intervention conducted through a web-conferencing platform. The personalized feedback intervention included tailored feedback on drinking quantity and frequency of alcohol, BAC, alcohol-related consequences, normative perceptions of peer drinking, alcohol outcome expectancies, family history of risk, and financial costs of alcohol. They also received up to 24 text messages with protective behavioral strategies for drinking during the following month.

BASICCS

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • being 18-29 years old; enrolled full- or part-time at one of the three community colleges where data collection took place; consuming 4+/5+ drinks for women/men on one occasion in the past month or exceeding weekly NIAAA drinking recommendations (8+/15+ for women/men); and possessing a cell phone with text-messaging capability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Christine M Lee, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were randomized into one of two conditions (BASICCS intervention and control \[assessment-only\]).
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two conditions (BASICCS and assessment-only control group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor, School of Medicine: Psychiatry

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

January 20, 2017

Primary Completion

June 26, 2017

Study Completion

June 26, 2017

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

We plan to share limited datasets for the purposes of data analysis and dissemination.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data dictionaries and limited datasets can be made available starting in September 2020.
Access Criteria
Individual requests to access data with intended purpose should be made to Dr. Lee and will be reviewed by the investigative team.

Locations