Alcohol Intervention for First Year College Students

NCT03750838 | Completed Results

• 2 other identifiers: R34AA0260041R34AA026004-01A1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

While a large focus of research on U.S. college drinking has focused on the prevalence of and problems related to heavy-episodic drinking, less has focused on college students who are either abstainers or lighter drinkers (i.e., for men, drinking 4 or fewer drinks in two hours and 14 or fewer drinks per week; and for women drinking 3 or fewer in two hours and 7 or fewer drinks per week). Over 40% percent of college students ages 18-22 do not report drinking in the past month with only half of those engaging in regular heavy-episodic drinking. Research suggests that a significant proportion of students who were abstinent or light drinkers prior to and upon entering college initiate drinking and progress to becoming heavy-episodic drinkers. This provides evidence that the first few months of college is a high-risk time for initiating both drinking and heavy-episodic drinking and that delaying the onset of heavy-episodic drinking among light drinkers and abstainers should lead to reduced harms throughout the college years and young adulthood. Mobile phone-based interventions are an innovative method for reaching young people and have been established as an empirical approach towards addressing health issues, including alcohol use. The ultimate goal of this proposal is to develop, refine and pilot a text message (TM) intervention for abstainer and lighter drinking first year college students with the ultimate goal of delaying alcohol initiation and/or reducing alcohol use escalation. An iterative process of focus groups, intervention content development, and user feedback focused on the unique experiences of abstainers and lighter drinkers will inform the TM Intervention to be delivered in a pilot study with 6 weeks of TMs. The pilot study will include a 6 week post-intervention assessment, and 3, 6, and 9 month follow-ups among 100 incoming first year abstainer and lighter drinker college students. Given that reducing young adults' and college students' engagement in excessive alcohol use has been listed as a major objective of Healthy People 2020 and a key priority of NIAAA, an intervention that focuses on delaying alcohol initiation and escalation into higher-risk alcohol use among abstainer and lighter drinkers could make important strides to achieving this goal.

Conditions

Underage Alcohol Use

Outcome Measures

Primary Outcomes (3)

• Acceptability-Number of Participants Who Found the Study Overall Favorable

  Item assessing whether participants found the study overall favorable as measured at 6-week follow-up.

  6 weeks

• Acceptability-proportion of Participants Who Would Recommend the Study

  Item assessed by asking whether participants would recommend the study to other first-year college students

  6 weeks

• Acceptability and Feasibility-ratings of Text Message Content Areas

  Text Message Rating Scale- assessed ratings of text message intervention content areas with a minimum value of 0 and a maximum value of 4 with higher numbers being a better outcome (i.e., more acceptable)

  6 weeks

Secondary Outcomes (8)

• 6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking)

  6 weeks

• 3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking)

  3 months

• 6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)

  6 months

• 9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use)

  9 months

• 6 Week Alcohol Quantity (Number of Drinks Per Week)

  6 weeks

Study Arms (2)

Text Messaging Intervention Group

EXPERIMENTAL

Participants in the Text Messaging Intervention condition will be provided a predetermined number of messages per week (based partially on responses from Phase 2 focus group) for 6 weeks delivered on Thursdays, Fridays, and Saturdays, which are the most common days of the week that heavy drinking occurs as well as other days and times that focus group participants indicated would be the most helpful.

Behavioral: Text Messaging Intervention

Assessment Only Control

NO INTERVENTION

Participants in the assessment only control will not receive any text messages, but will complete all survey assessments on the same schedule as the Text Message Intervention Group.

Interventions

Text Messaging Intervention BEHAVIORAL

The content for the text messaging Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.

Text Messaging Intervention Group

Eligibility Criteria

• Age: 18 Years - 19 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligibility criteria includes:
• age 18-19 (see Identity and Age Verification below; If a participant screens in at 18 and turns 20 prior to the focus group, the participant will be allowed to be in the research study.)
• birth date that is consistent with their given age
• first-year college student at the University of North Texas
• valid email address
• have a text messaging plan on their mobile phone
• drinking 14/7 or fewer drinks per week for men/women
• no episodes in the past month of consuming 5/4 drinks in two hours for men/women
• express any willingness to take a sip of alcohol
• if female, must not be pregnant or trying to get pregnant
• willing to participate in focus groups at the University of North Texas

You may not qualify if:

• unwillingness to participate
• failure to provide consent (e.g., declining participation in the study)
• providing inconsistent responses (e.g., age) identified by the survey
• having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics

Sponsors & Collaborators

• University of North Texas Health Science Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Dana

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Underage Drinking

Condition Hierarchy (Ancestors)

Adolescent Behavior; Behavior; Alcohol Drinking; Drinking Behavior

Limitations and Caveats

The trial, which studied the Freshman college experience, took place during the COVID-19 pandemic, and thus results may not fully generalize.

Results Point of Contact

• Title: Dr. Dana Litt
• Organization: University of North Texas Health Science Center

dana.litt@unthsc.edu

817-735-5453

Study Officials

• Dana M Litt, PhD.

  University of North Texas Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Health Behavior and Health Systems

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: June 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 19, 2024
• Results First Posted: January 19, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)