A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: behavioral activation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: College freshmen enrolled in UNIV 101 freshman seminar courses at the University of Kansas assigned to the study Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation Course<br>Behavioral activation course condition administered in a college freshman orientation seminar | Behavioral: behavioral activation<br>* 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).<br>|
| No Intervention: Standard Orientation Course<br>Standard freshman orientation seminar course condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depression | Depression will be 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. Thus, the DASS-21 is appropriate for use in a non-clinical, college sample. 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 more depression. | baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2 | 
| binge eating | Binge eating will be measured with the Eating Pathology Symptoms Inventory (EPSI; Forbush et al., 2013). The EPSI conceptualizes eating behavior on a dimensional scale and is appropriate for use in samples with and without eating disorders. The binge eating subscale will be used in the proposed 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. | baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2 | 
| stress | Stress will be 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 measure conceptualizes the difference between normal and clinical populations in stress as a matter of degree. Thus, the DASS-21 is appropriate for use in a non-clinical, college sample. b. The stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient 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 more stress. | baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral activation, prevention, reinforcement, college students