Skip to content

A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04038190
Enrollment
572
Registered
2019-07-30
Start date
2019-09-05
Completion date
2025-05-30
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

BEHAVIORALbehavioral 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).

Sponsors

University of Kansas
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

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

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes

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

MeasureTime frameDescription
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) ScoreDuring 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 AUDITDuring 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

MeasureTime frameDescription
DepressionDuring 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 EatingDuring 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.
StressDuring 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

PRINCIPAL_INVESTIGATORTera L Fazzino, PhD

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 typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2870 / 285
other
Total, other adverse events
0 / 2870 / 285
serious
Total, serious adverse events
0 / 2870 / 285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026