Clinical trial NCT04038190: A Behavioral Activation Intervention Administered in a College Freshman Orientation Course
Official title: A Cluster-randomized Trial of a Behavioral Activation Intervention Administered in a College Freshman Orientation Course
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol; Use, Problem
Stress
Binge Eating
Depression
Keywords: behavioral activation
prevention
reinforcement
college students
Lead sponsor: University of Kansas
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-07-30
Enrollment: 540
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: alcohol consumption
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
measure: high-intensity drinking (2+ times in excess of NIAAA low risk drinking guidelines for males and females)
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
measure: alcohol-related problems
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
measure: exceeding clinical cutoff of 8+ for hazardous/harmful drinking
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Secondary outcomes:
measure: depression
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
measure: binge eating
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
measure: stress
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Other outcomes:
measure: delay discounting
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
measure: reinforcement from alcohol-related and alcohol-free activities
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
measure: coping-motivated drinking
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
measure: grade point average (GPA)
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
measure: alcohol violations on campus
timeFrame: baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Locations:
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
Study officials:
affiliation: University of Kansas
name: Tera L Fazzino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.