A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

NCT04038190 | Completed Phase 2 Results DMC

• 2 other identifiers: STUDY001439541R01AA027791-01
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

behavioral activation; prevention; reinforcement; college students

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

  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

  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 Outcomes (6)

• Delay Discounting Rate

  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

  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

  During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

Study Arms (2)

Behavioral Activation Course

EXPERIMENTAL

Behavioral activation course condition administered in a college freshman orientation seminar

Behavioral: behavioral activation

Standard Orientation Course

NO INTERVENTION

Standard freshman orientation seminar course condition

Interventions

behavioral activation BEHAVIORAL

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).

Behavioral Activation Course

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Kansas: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Kansas

Lawrence, Kansas, 66046, United States

Location

Related Publications (4)

• 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.

  PMID: 37072099 BACKGROUND

• 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.

  PMID: 36833579 RESULT

• 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.

  PMID: 31982647 RESULT

• 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.

  PMID: 37583941 RESULT

MeSH Terms

Conditions

Alcoholism; Bulimia; Depression

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Limitations and Caveats

In our original analysis plan, we proposed to explore the moderating effects of race/ethnicity in intervention efficacy. However, while we obtained variability across individuals identifying across various race and ethnicity groups, we lacked sufficient statistical power to explore effects of groups other than White, non-Hispanic. Therefore, we have chosen not to report this outcome

Results Point of Contact

• Title: Tera Fazzino, PhD, Principal Investigator
• Organization: University of Kansas

tfazzino@ku.edu

7858640062

Study Officials

• Tera L Fazzino, PhD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The purpose of the study is to conduct a 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. A random sample of 20% of participants will complete a 17 month follow up to examine long term effects.

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 30, 2019
• Study Start: September 5, 2019
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: May 28, 2026
• Results First Posted: May 28, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)