A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

NCT ID: NCT04038190

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-05
• Study Completion Date: 2025-06-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Behavioral Activation Course

Behavioral activation course condition administered in a college freshman orientation seminar

Group Type: EXPERIMENTAL

behavioral activation

Intervention Type: 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).

Standard Orientation Course

Standard freshman orientation seminar course condition

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Kansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tera L Fazzino, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas

Locations

University of Kansas

Lawrence, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tera L Fazzino, PhD

Role: CONTACT

tfazzino@ku.edu

7858640062

Richard Yi, PhD

Role: CONTACT

ryi1@ku.edu

Facility Contacts

Tera L Fazzino

Role: primary

tfazzino@ku.edu

785-864-0062

Richard Yi

Role: backup

ryi1@ku.edu

785-864-6476

References

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.

Reference Type: BACKGROUND

PMID: 37583941 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31982647 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36833579 (View on PubMed)

Other Identifiers

1R01AA027791-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00143954

Identifier Type: -

Identifier Source: org_study_id