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NCT07905846
A Hybrid Type 1 Randomized Controlled Trial of an Online and Text-Messaging Intervention to Prevent Alcohol and Cannabis Initiation, Escalation, and Consequences Among First-Year College Students
Conditions: Alcohol, Cannabis
Sex: All
Ages: 18 Years – 19 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 800
Sponsor: The University of Texas at Arlington
Summary
Building on promising pilot findings, this study will employ a Hybrid Type 1 Effectiveness-Implementation RCT to evaluate the effectiveness of a novel intervention for first-year college students who abstain from or use alcohol and cannabis lightly, compared to assessment-only control. Aim 1 will finalize the intervention through student feedback to ensure relevance and engagement and Aim 2 will test its impact on abstaining and light alcohol and cannabis use, related consequences, and key cognitive and behavioral outcomes in a two-arm RCT (N = 800) across the first semester and academic year. Aim 3 will assess early implementation outcomes using mixed methods, including focus groups with a Campus Advisory Board, validated survey measures, and intervention analytics, to inform future dissemination and implementation strategies.
Eligibility Criteria
Inclusion Criteria: 1) 18-19 at the time of screening; 2) birthdate consistent with age; 3) first-year student at UTA; 4) no lifetime alcohol use or alcohol use in the past month limited to one day per week or less and never exceeding 4 drinks (women) or 5 drinks (men) on a single occasion at any point in their lifetime; 5) no lifetime cannabis use or cannabis use in the past month limited to one day per week or less and never exceeding that frequency at any point in their lifetime; 6) valid email; 7) valid mobile number with TM plan; and 8) no past or current treatment for alcohol or cannabis.
Exclusion Criteria: Exclusion criteria include not meeting inclusion criteria (see Inclusion Criteria above), unwillingness to participate, failure to provide consent (e.g., declining participation in the study), providing inconsistent responses (e.g., age) identified by the eligibility survey and introductory study telephone call, and having already participated in the study as identified by overlap or consistency in computer IP addresses, contact information, and demographics.
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Source: ClinicalTrials.gov (NCT07905846). StuddyBuddy aggregates publicly available trial information.