A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

A Cluster-randomized Trial of a Behavioral Activation Intervention Administered in a College Freshman Orientation Course

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.

Study Overview

• Status: Completed
• Conditions: Depression; Stress; Binge Eating; Alcohol; Use, Problem
• Intervention / Treatment: Behavioral: behavioral activation

Detailed Description

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. Low rates of engagement with treatment resources may occur because interventions target drinking directly at a time when students may be uninterested in changing their drinking. Moreover, with a targeted focus on alcohol use, current interventions also do not address the concerns of incoming freshmen, such as stress and sleep. Approaches that address the problems students are most concerned about, that also indirectly reduce drinking, may be particularly effective.

Behavioral activation (BA) is an intervention that indirectly addresses psychopathy by guiding individuals to identify goals in their lives, and encouraging individuals to engage in reinforcing activities that align with their goals (Lejuez et al, 2001). While initially used to treat depression, BA has been efficaciously applied to substance use because BA acts on the same reinforcement process implicated in problem drinking. BA addresses drinking without specific reference to alcohol use by focusing on engagement in reinforcing activities that align with students' goals. A pilot study provided initial indication that a brief BA intervention administered in a semester-long freshman orientation course resulted in a significant decrease in drinking-related problems, compared to standard orientation (Reynolds et al. 2011). Notably, the approach never raised the issue of drinking unless raised by a student themselves.

The purpose of the study is to conduct a fully powered cluster randomized trial testing BA administered in a semester-long (16 week) freshman orientation course, compared to a standard orientation course in 540 freshmen spread over 36 course sections (18 sections each of the BA and standard orientation format). A 5-month post-treatment assessment will measure durability of effects. Mediation analyses will test mechanisms of action and moderation analyses will examine factors related to efficacy. A random sample of 20% of participants will complete a 17 month follow up, which will occur at the end of their sophomore year of college, to examine long term effects. With this proposed R01, the investigators will test a promising intervention with BA that addresses factors limiting participation in other programs by not targeting alcohol directly and by integrating an intervention into college curriculum, with the additional benefit of testing mediators to guide future work. This application represents a first step toward developing an intervention course that could be widely disseminated to address the persistent college drinking problem and its many consequences.

• Study Type: Interventional
• Enrollment (Actual): 572
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lawrence, Kansas, United States, 66046
      • University of Kansas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Activation Course; Behavioral activation course condition administered in a college freshman orientation seminar	Behavioral: behavioral activation; Behavioral activation (BA) is an intervention that indirectly addresses psychopathy by guiding individuals to identify goals in their lives, and encouraging individuals to engage in reinforcing activities that align with their goals (Lejuez et al, 2001). While initially used to treat depression, BA has been efficaciously applied to substance use because BA acts on the same reinforcement system common to many disorders (Daughters et al., 2018).
No Intervention: Standard Orientation Course; Standard freshman orientation seminar course condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Consumption (AUDIT-C Score)	Alcohol-Use Disorders Identification Test- Consumption Questions (AUDIT-C), which are the first three items of the AUDIT 10-item measure that asses frequency of drinking, typical quantity, and frequency of heavy drinking occasions (Saunders et al, 1993; Bush et al, 1998; DeMartini et al 2012). Responses are on a likert scale ranging from 0-4. The 3 items are summed for a total score with a possible range of 0-12, with higher scores indicating riskier drinking behavior.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)	The Time Line Follow Back-Computerized (TLFB-C) assessment was used to measure alcohol consumption in the past 30 days (Sobell & Sobell, 2008), or since the prior measurement period. The measure was used to obtain the number of days during which individuals engaged in high-intensity drinking of 8+ drinks for males or 10+ drinks for females per drinking occasion. The number of days participants engaged in high intensity drinking was summed per measurement period, and converted to a rate to reflect the number of high intensity drinking days out of the number of days in the measurement period (high intensity drinking days/days in measurement period). The rate was used because there could be slightly different numbers of days across measurement periods, depending on when participants completed the assessment.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Alcohol-related Problems (AUDIT-P) Score	Alcohol-Use Disorders Identification Test- Problem questions (AUDIT-P) are the last 7 items of the full AUDIT that assess increased salience of drinking, morning drinking, guilt after drinking, blackouts, alcohol-related injuries, and drinking that others are concerned about (Saunders et al, 1993; O'Hare & Sherrer, 2005). Responses are on a likert scale ranging from 0-4. The 7 items were summed for a total score on the AUDIT-P, with a possible range of 0-28, with higher scores indicating greater alcohol-related problems.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT	The Alcohol-Use Disorders Identification Test (AUDIT) is designed to assess hazardous alcohol use and alcohol-related problems. The AUDIT has 10 items (Saunders et al, 1993) and responses are on a likert scale ranging from 0-4. The 10 items are summed for a total score with a possible range of 0-40, with higher scores indicating greater likelihood of hazardous drinking behavior. A total score of 8 or higher was used as a binary variable to identify participants with hazardous drinking (score 8+). Outcome was the proportion of respondents exceeding the clinical cut point.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Depression was measured using the Depression Anxiety Stress Scale (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995). The measure provides scales for depression, anxiety, and stress and conceptualizes the difference between normal and clinical populations as a matter of degree. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia with 7 items. Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21. Higher scores indicate greater depression.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Binge Eating	Binge eating was measured with the Eating Pathology Symptoms Inventory (EPSI; Forbush et al., 2013). The binge eating subscale was used in the study, which includes items on overeating and loss of control eating. The binge eating subscale has 8 items with Likert scale responses from 0=never to 4= very often. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Stress	Stress was measured using the Depression Anxiety Stress Scale-21 (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995). The stress scale score was used to assess stress. Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21. Higher scores indicate greater stress.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay Discounting Rate	Delay discounting was calculated from a computer adjusting delay discounting task that asked participants to choose between smaller immediate rewards and larger, delayed rewards. The reward used in the task was hypothetical money. Mazur's hyperbolic function, V = A/ 1 + kD, was used to estimate each participant's delay discounting rate (i.e., k) for use in analyses. For this formula, V is the discounted value of a delayed reward (i.e., indifference point), A is the reward amount, D is the delay in days, and k represents the estimated delay discounting rate. Greater k values indicated stronger discounting and a preference for immediate monetary rewards. K values across the sample ranged from -11.06 to 2.43. Negative values generally indicate stronger discounting, whereas positive values typically represent less steep discounting.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Total Reinforcement Ratio (TRR) Between Alcohol-related and Alcohol-free Sources of Reinforcement	The Adolescent Reinforcement Survey Schedule - Alcohol Use Version assesses the frequency of past-month engagement in and enjoyment derived from 45 activities (Hallgren et al, 2016). Each question is posed twice - once to assess the frequency and enjoyment of the activity while using alcohol and the once to assess the frequency and enjoyment of the activity while not using alcohol. Items range from 0-4. Frequency and enjoyment items are summed to form respective scores. From these scales, two subscales are created for alcohol-related reinforcement and alcohol-free reinforcement, calculated as the cross product between frequency and enjoyment items for alcohol-related and alcohol-free questions. The two subscales were used to calculate the outcome, the total reinforcement ratio (TRR) between alcohol-related and alcohol-free reinforcement. The ratio has values between 0 and 1, with higher values indicating more relative enjoyment of activities when using alcohol.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Moderation of Treatment Effects (AUDIT Total) Based on Coping-motivated Drinking	Moderator: The Drinking Motives Questionnaire-Revised (DMQ-R) is designed to measure the relative frequency of drinking for four distinct reason motives: enhancement, social, conformity, and coping (Cooper, 1994; Cox & Klinger, 1988). The study used the coping motives scale, which contains 5 items. Items are assessed on a Likert scale ranging from 1-5 and are summed for form a scale score, which higher scores indicating greater endorsement of drinking to cope with stress/distress. Outcome: The outcome used in the analysis was the Alcohol Use Disorder Identification Test (AUDIT) total score; we originally planned to use AUDIT-Consumption and AUDIT-Problems subscales for two separate analyses and outcomes (in parallel with other moderation analyses); however the models did not converge. Therefore, AUDIT total score was used as the outcome in analyses.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Grade Point Average (GPA)	Academic performance was measured using participant self-reported grade point average (GPA). College freshmen first received their GPA in the spring semester of college, which was at the 5 month follow up. Thus, we examined whether there were significant differences in GPA across treatment and control conditions at 5 month adn 17 month follow ups.	GPA was available and assessed during post-treatment follow up at and 5 months (all participants) and 17 months (for participants in Years 1-3)
Moderation of Treatment Effects (AUDIT-C) by Sex	The moderator used in analyses was sex. The outcome was the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) subscale score.	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Moderation of Treatment Effects (AUDIT-P) by Sex	The moderator in the model was sex. The outcome was the Alcohol Use Disorder Identification Test-Problems (AUDIT-P) subscale score	During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

Collaborators and Investigators

• Sponsor: University of Kansas
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Tera L Fazzino, PhD, University of Kansas

Publications and helpful links

General Publications

• Fazzino TL, Lejuez CW, Yi R. A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol. Contemp Clin Trials. 2020 Mar;90:105950. doi: 10.1016/j.cct.2020.105950. Epub 2020 Jan 23.
• Jun D, Fazzino TL. Associations between Alcohol-Free Sources of Reinforcement and the Frequency of Alcohol and Cannabis Co-Use among College Freshmen. Int J Environ Res Public Health. 2023 Feb 7;20(4):2884. doi: 10.3390/ijerph20042884.
• Exum AC, Sutton CA, Bellitti JS, Yi R, Fazzino TL. Delay discounting and substance use treatment outcomes: A systematic review focused on treatment outcomes and discounting methodology. J Subst Use Addict Treat. 2023 Jun;149:209037. doi: 10.1016/j.josat.2023.209037. Epub 2023 Apr 16.
• Fazzino TL, Kunkel A, Bellitti J, Romine RS, Yi R, McDaniel C, Lejuez CW. Engagement with Activity Monitoring During a Behavioral Activation Intervention: A Randomized Test of Monitoring Format and Qualitative Evaluation of Participant Experiences. Behav Change. 2023 Jun;40(2):103-116. doi: 10.1017/bec.2022.7. Epub 2022 Jun 16.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: prevention; behavioral activation; college students; reinforcement
• Additional Relevant MeSH Terms: Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Behavioral Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Bulimia; Alcoholism; Depression
• Other Study ID Numbers: STUDY00143954; 1R01AA027791-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No