Alcohol; Use, Problem, Binge Eating, Depression, Stress
Conditions
Keywords
behavioral activation, prevention, reinforcement, college students
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.
Interventions
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).
Sponsors
Study design
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.
Eligibility
Inclusion criteria
* College freshmen enrolled in UNIV 101 freshman seminar courses at the University of Kansas assigned to the study
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Consumption (AUDIT-C Score) | 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-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. |
| Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females) | 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) | 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. |
| Alcohol-related Problems (AUDIT-P) Score | 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-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. |
| Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Depression was 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. 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 greater depression. |
| 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) | Binge eating was measured with the Eating Pathology Symptoms Inventory (EPSI; Forbush et al., 2013). The binge eating subscale was used in the 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. |
| 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) | Stress was 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 stress scale score was used to assess stress. 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 greater stress. |
Countries
United States
Contacts
University of Kansas
Participant flow
Recruitment details
UNIV 101 freshman orientation seminar courses, N=36, were assigned to the study team and cluster-randomized to the Behavioral Activation (BA) intervention condition or the Standard Orientation (SO) course section. Participants enrolled in UNIV 101 course sections through the university registrar. In the beginning of the semester, the study team dropped into each course section and invited students to consent to participate in the study.
Pre-assignment details
BA = 18 UNIV 101 course sections assigned SO = 18 UNIV 101 course sections assigned BA = 287 participants consented SO= 285 participants consented
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 17 years old | 9 Participants |
| Age, Customized 18 years old | 468 Participants |
| Age, Customized 19 years old | 84 Participants |
| Age, Customized 20 years old | 6 Participants |
| Age, Customized 21 + years old | 5 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander No | 273 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander Yes | 28 Participants |
| Race/Ethnicity, Customized Black/African American No | 270 Participants |
| Race/Ethnicity, Customized Black/African American Yes | 15 Participants |
| Race/Ethnicity, Customized Ethnicity: Hispanic/Latino No | 498 Participants |
| Race/Ethnicity, Customized Ethnicity: Hispanic/Latino Yes | 29 Participants |
| Race/Ethnicity, Customized Ethnicity: Middle Eastern/North African (yes/no) No | 279 Participants |
| Race/Ethnicity, Customized Ethnicity: Middle Eastern/North African (yes/no) Yes | 6 Participants |
| Race/Ethnicity, Customized More than one race No | 261 Participants |
| Race/Ethnicity, Customized More than one race Yes | 51 Participants |
| Race/Ethnicity, Customized Native American No | 285 Participants |
| Race/Ethnicity, Customized Native American Yes | 2 Participants |
| Race/Ethnicity, Customized Other No | 556 Participants |
| Race/Ethnicity, Customized Other Yes | 6 Participants |
| Race/Ethnicity, Customized Unknown No | 571 Participants |
| Race/Ethnicity, Customized Unknown Yes | 0 Participants |
| Race/Ethnicity, Customized White No | 67 Participants |
| Race/Ethnicity, Customized White Yes | 208 Participants |
| Sex/Gender, Customized Female No | 127 Participants |
| Sex/Gender, Customized Female Yes | 324 Participants |
| Sex/Gender, Customized Intersex No | 283 Participants |
| Sex/Gender, Customized Intersex Yes | 0 Participants |
| Sex/Gender, Customized Male No | 327 Participants |
| Sex/Gender, Customized Male Yes | 118 Participants |
| Sex/Gender, Customized Unknown No | 284 Participants |
| Sex/Gender, Customized Unknown Yes | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 287 | 0 / 285 |
| other Total, other adverse events | 0 / 287 | 0 / 285 |
| serious Total, serious adverse events | 0 / 287 | 0 / 285 |