A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

NCT04038190 | Unknown Phase 2 DMC

• 2 other identifiers: STUDY001439541R01AA027791-01
• Study Type: interventional
• Target: 540
• 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

  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.

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

• high-intensity drinking (2+ times in excess of NIAAA low risk drinking guidelines for males and females)

  The 30-day Time Line Follow Back-Computerized (TLFB-C) assessment will be used to measure alcohol consumption in the past 30 days (Sobell et al, 1996; Sobell \& Sobell, 1992; Sobell \& Sobell, 2008). The measure will be used to obtain the frequency at which individuals engaged in high-intensity drinking of 8+ drinks for males or 10+ drinks for females in one occasion.

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

• alcohol-related problems

  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 are summed for a total score with a possible range of 0-28, with higher scores indicating greater alcohol-related problems.

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

• exceeding clinical cutoff of 8+ for hazardous/harmful drinking

  The Alcohol-Use Disorders Identification Test (AUDIT) is designed to assess hazardous alcohol use and alcohol-related problems. The AUDIT has 10 items that assesses frequency of drinking, typical quantity, frequency of heavy drinking, impaired control over drinking, increased salience of drinking, morning drinking, guilt after drinking, blackouts, alcohol-related injuries, and others concerned about (Saunders et al, 1993). 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.

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

Secondary Outcomes (3)

• depression

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

• binge eating

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

• stress

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

Other Outcomes (5)

• delay discounting

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

• reinforcement from alcohol-related and alcohol-free activities

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

• coping-motivated drinking

  baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2

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

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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

• 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

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

Study Officials

• Tera L Fazzino, PhD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tera L Fazzino, PhD

CONTACT

7858640062; tfazzino@ku.edu

Richard Yi, PhD

CONTACT

ryi1@ku.edu

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: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)