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Phase 2 N=572 Randomized Single-blind Prevention

A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

Alcohol; Use, Problem · Stress · Binge Eating · Depression

Enrolled (actual)
572
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Alcohol Consumption (AUDIT-C Score) — 2.933; 2.574; 3.167; 2.619 AUDIT-C score — p=0.4226

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
behavioral activation (Behavioral)
Age
Pediatric, Adult, Older Adult · 17+ yrs
Sex
All
Sponsor
University of Kansas
Primary completion
May 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Alcohol Consumption (AUDIT-C Score)
2.933; 2.574; 3.167; 2.619; 3.210; 2.691 0.4226
PRIMARY
Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
.005; .004; .002; .002; .004; .004 0.8675
PRIMARY
Alcohol-related Problems (AUDIT-P) Score
0.937; 1.116; 1.448; 1.095; 1.613; 1.389 0.4782
PRIMARY
Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
.214; .159; .230; .179; .277; .211 0.3803
SECONDARY
Depression
3.053; 3.228; 3.607; 3.260; 3.817; 3.644 0.7292
SECONDARY
Binge Eating
7.243; 6.541; 6.392; 5.870; 5.423; 5.233 0.8278
SECONDARY
Stress
4.821; 4.691; 4.533; 4.669; 4.515; 4.571 0.8488

Summary

The transition from high school to college is a developmentally sensitive period that is high risk for escalations in alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. The proposed study will test a behavioral activation intervention that addresses factors limiting participation in standard treatment services by targeting alcohol use indirectly, by directly addressing concerns most relevant to incoming college freshmen, and by integrating an intervention into the college curriculum.

Eligibility Criteria

Inclusion Criteria

  • College freshmen enrolled in UNIV 101 freshman seminar courses at the University of Kansas assigned to the study

Exclusion Criteria

  • None
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04038190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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