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NCT03750838

Alcohol Intervention for First Year College Students

Completed NA Results posted Last updated 19 January 2024
What this trial tests

NA trial testing Text Messaging Intervention in Underage Alcohol Use in 99 participants. Completed in 1 August 2023.

Timeline
1 June 2021
Primary endpoint
1 August 2023
1 August 2023

Quick facts

Lead sponsorUniversity of North Texas Health Science Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment99
Start date1 June 2021
Primary completion1 August 2023
Estimated completion1 August 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of North Texas Health Science Center

Who can join

Adults 18 to 19, any sex, with Underage Alcohol Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability-Number of Participants Who Found the Study Overall Favorable Primary · 6 weeks

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

GroupValue95% CI
Text Messaging Intervention Group38
Assessment Only Control0
Acceptability-proportion of Participants Who Would Recommend the Study Primary · 6 weeks

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

GroupValue95% CI
Text Messaging Intervention Group36
Assessment Only Control0
Acceptability and Feasibility-ratings of Text Message Content Areas Primary · 6 weeks

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)

Substance free activities text messages
GroupValue95% CI
Text Messaging Intervention Group3.27± 0.16
Image text messages
GroupValue95% CI
Text Messaging Intervention Group3.00± 0.47
Norms text messages
GroupValue95% CI
Text Messaging Intervention Group2.72± 0.66
Goals text messages
GroupValue95% CI
Text Messaging Intervention Group2.88± 0.33
Protective Behavioral Strategies text messages
GroupValue95% CI
Text Messaging Intervention Group2.48± 0.14
6 Week Alcohol Initiation (Number of Participants Who Initiated Drinking) Secondary · 6 weeks

Number of participants who initiated drinking since the baseline assessment

GroupValue95% CI
Text Messaging Intervention Group6
Assessment Only Control3
3 Month Alcohol Initiation (Number of Participants Who Initiated Drinking) Secondary · 3 months

Number of participants who initiated drinking at the 3 month assessment since the 6 week assessment

GroupValue95% CI
Text Messaging Intervention Group4
Assessment Only Control3
6 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use) Secondary · 6 months

Number of participants who initiated alcohol use at 6 month assessment since the 3 month assessment

GroupValue95% CI
Text Messaging Intervention Group4
Assessment Only Control7
9 Month Alcohol Initiation (Number of Participants Who Initiated Alcohol Use) Secondary · 9 months

Number of participants who initiated drinking at 9 month assessment since the 6 month assessment

GroupValue95% CI
Text Messaging Intervention Group6
Assessment Only Control4
6 Week Alcohol Quantity (Number of Drinks Per Week) Secondary · 6 weeks

Number of drinks consumed each week as measured at 6 week assessment

GroupValue95% CI
Text Messaging Intervention Group1.89± 2.98
Assessment Only Control2.03± 3.34
3 Month Alcohol Quantity (Number of Drinks) Secondary · 3 months

Number of drinks consumed each week as measured at 3 month assessment

GroupValue95% CI
Text Messaging Intervention Group1.52± 2.38
Active Control2.03± 2.78
6 Month Alcohol Quantity (Number of Drinks Consumed Per Week) Secondary · 6 months

Number of drinks consumed each week as measured at 6 month assessment

GroupValue95% CI
Text Messaging Intervention Group1.48± 2.62
Assessment Only Control1.67± 3.39
9 Month Alcohol Quantity (Number of Drinks Consumed Per Week) Secondary · 9 months

Number of drinks consumed each week as measured at 9 month assessment

GroupValue95% CI
Text Messaging Intervention Group1.46± 2.74
Assessment Only Control1.21± 2.20

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Text Messaging Intervention

Trials testing the same drug.

Other University of North Texas Health Science Center trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03750838.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing