Trial Outcomes & Findings for A Behavioral Activation Intervention Administered in a College Freshman Orientation Course (NCT NCT04038190)

NCT ID: NCT04038190

Last Updated: 2026-05-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

572 participants

Primary outcome timeframe

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)

Results posted on

2026-05-28

Participant Flow

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.

BA = 18 UNIV 101 course sections assigned SO = 18 UNIV 101 course sections assigned BA = 287 participants consented SO= 285 participants consented

Unit of analysis: UNIV 101 course sections

Participant milestones

Participant milestones
Measure
Behavioral Activation Condition (BA)
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
Courses were cluster-randomized to the standard orientation (SO) course condition
Baseline
STARTED
287 18
285 18
Baseline
COMPLETED
287 18
285 18
Baseline
NOT COMPLETED
0 0
0 0
Visit 2 (Mid-semester)
STARTED
287 18
285 18
Visit 2 (Mid-semester)
COMPLETED
286 18
284 18
Visit 2 (Mid-semester)
NOT COMPLETED
1 0
1 0
Visit 3 (End of Semester)
STARTED
287 18
285 18
Visit 3 (End of Semester)
COMPLETED
283 18
282 18
Visit 3 (End of Semester)
NOT COMPLETED
4 0
3 0
Follow Up: 5-months Post Treatment
STARTED
287 18
285 18
Follow Up: 5-months Post Treatment
COMPLETED
197 18
206 18
Follow Up: 5-months Post Treatment
NOT COMPLETED
90 0
79 0
Follow Up: 17-months(Cohorts 1-3)
STARTED
287 18
224 18
Follow Up: 17-months(Cohorts 1-3)
COMPLETED
155 18
121 18
Follow Up: 17-months(Cohorts 1-3)
NOT COMPLETED
132 0
103 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participants could select more than one race or ethnicity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Behavioral Activation Condition (BA)
n=287 Participants
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=285 Participants
Courses were cluster-randomized to the standard orientation (SO) course condition
Total
n=572 Participants
Total of all reporting groups
Age, Customized
17 years old
5 Participants
n=51 Participants
4 Participants
n=14 Participants
9 Participants
n=65 Participants
Age, Customized
18 years old
230 Participants
n=51 Participants
238 Participants
n=14 Participants
468 Participants
n=65 Participants
Age, Customized
19 years old
46 Participants
n=51 Participants
38 Participants
n=14 Participants
84 Participants
n=65 Participants
Age, Customized
20 years old
3 Participants
n=51 Participants
3 Participants
n=14 Participants
6 Participants
n=65 Participants
Age, Customized
21 + years old
3 Participants
n=51 Participants
2 Participants
n=14 Participants
5 Participants
n=65 Participants
Sex/Gender, Customized
Male · Yes
127 Participants
n=51 Participants
118 Participants
n=14 Participants
245 Participants
n=65 Participants
Sex/Gender, Customized
Male · No
160 Participants
n=51 Participants
167 Participants
n=14 Participants
327 Participants
n=65 Participants
Sex/Gender, Customized
Female · Yes
160 Participants
n=51 Participants
164 Participants
n=14 Participants
324 Participants
n=65 Participants
Sex/Gender, Customized
Female · No
127 Participants
n=51 Participants
121 Participants
n=14 Participants
248 Participants
n=65 Participants
Sex/Gender, Customized
Intersex · Yes
0 Participants
n=51 Participants
2 Participants
n=14 Participants
2 Participants
n=65 Participants
Sex/Gender, Customized
Intersex · No
287 Participants
n=51 Participants
283 Participants
n=14 Participants
570 Participants
n=65 Participants
Sex/Gender, Customized
Unknown · Yes
0 Participants
n=51 Participants
1 Participants
n=14 Participants
1 Participants
n=65 Participants
Sex/Gender, Customized
Unknown · No
287 Participants
n=51 Participants
284 Participants
n=14 Participants
571 Participants
n=65 Participants
Race/Ethnicity, Customized
White · Yes
208 Participants
n=51 Participants • Participants could select more than one race or ethnicity
218 Participants
n=14 Participants • Participants could select more than one race or ethnicity
426 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
White · No
79 Participants
n=51 Participants • Participants could select more than one race or ethnicity
67 Participants
n=14 Participants • Participants could select more than one race or ethnicity
146 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Black/African American · Yes
26 Participants
n=51 Participants • Participants could select more than one race or ethnicity
15 Participants
n=14 Participants • Participants could select more than one race or ethnicity
41 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Black/African American · No
261 Participants
n=51 Participants • Participants could select more than one race or ethnicity
270 Participants
n=14 Participants • Participants could select more than one race or ethnicity
531 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Asian or Pacific Islander · Yes
14 Participants
n=51 Participants • Participants could select more than one race or ethnicity
14 Participants
n=14 Participants • Participants could select more than one race or ethnicity
28 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Asian or Pacific Islander · No
273 Participants
n=51 Participants • Participants could select more than one race or ethnicity
271 Participants
n=14 Participants • Participants could select more than one race or ethnicity
544 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Native American · Yes
2 Participants
n=51 Participants • Participants could select more than one race or ethnicity
7 Participants
n=14 Participants • Participants could select more than one race or ethnicity
9 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Native American · No
285 Participants
n=51 Participants • Participants could select more than one race or ethnicity
278 Participants
n=14 Participants • Participants could select more than one race or ethnicity
563 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
More than one race · Yes
26 Participants
n=51 Participants • Participants could select more than one race or ethnicity
25 Participants
n=14 Participants • Participants could select more than one race or ethnicity
51 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
More than one race · No
261 Participants
n=51 Participants • Participants could select more than one race or ethnicity
260 Participants
n=14 Participants • Participants could select more than one race or ethnicity
521 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Other · Yes
10 Participants
n=51 Participants • Participants could select more than one race or ethnicity
6 Participants
n=14 Participants • Participants could select more than one race or ethnicity
16 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Other · No
277 Participants
n=51 Participants • Participants could select more than one race or ethnicity
279 Participants
n=14 Participants • Participants could select more than one race or ethnicity
556 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Unknown · Yes
1 Participants
n=51 Participants • Participants could select more than one race or ethnicity
0 Participants
n=14 Participants • Participants could select more than one race or ethnicity
1 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Unknown · No
286 Participants
n=51 Participants • Participants could select more than one race or ethnicity
285 Participants
n=14 Participants • Participants could select more than one race or ethnicity
571 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Ethnicity: Hispanic/Latino · Yes
45 Participants
n=51 Participants • Participants could select more than one race or ethnicity
29 Participants
n=14 Participants • Participants could select more than one race or ethnicity
74 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Ethnicity: Hispanic/Latino · No
242 Participants
n=51 Participants • Participants could select more than one race or ethnicity
256 Participants
n=14 Participants • Participants could select more than one race or ethnicity
498 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Ethnicity: Middle Eastern/North African (yes/no) · Yes
7 Participants
n=51 Participants • Participants could select more than one race or ethnicity
6 Participants
n=14 Participants • Participants could select more than one race or ethnicity
13 Participants
n=65 Participants • Participants could select more than one race or ethnicity
Race/Ethnicity, Customized
Ethnicity: Middle Eastern/North African (yes/no) · No
280 Participants
n=51 Participants • Participants could select more than one race or ethnicity
279 Participants
n=14 Participants • Participants could select more than one race or ethnicity
559 Participants
n=65 Participants • Participants could select more than one race or ethnicity

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 coursesection
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 coursesection
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Alcohol Consumption (AUDIT-C Score)
Baseline
2.933 AUDIT-C score
Standard Deviation 2.994
2.574 AUDIT-C score
Standard Deviation 2.784
Alcohol Consumption (AUDIT-C Score)
Visit 2
3.167 AUDIT-C score
Standard Deviation 3.019
2.619 AUDIT-C score
Standard Deviation 2.859
Alcohol Consumption (AUDIT-C Score)
Visit 3
3.210 AUDIT-C score
Standard Deviation 3.039
2.691 AUDIT-C score
Standard Deviation 2.766
Alcohol Consumption (AUDIT-C Score)
Visit 4 (5-mo follow up)
3.199 AUDIT-C score
Standard Deviation 2.932
3.029 AUDIT-C score
Standard Deviation 2.919
Alcohol Consumption (AUDIT-C Score)
Visit 5 (17 mo follow up)
3.617 AUDIT-C score
Standard Deviation 3.092
3.110 AUDIT-C score
Standard Deviation 2.823

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
Visit 3
.004 high intensity drinking days/meas. days
Standard Deviation .026
.004 high intensity drinking days/meas. days
Standard Deviation .024
Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
Baseline
.005 high intensity drinking days/meas. days
Standard Deviation .025
.004 high intensity drinking days/meas. days
Standard Deviation .024
Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
Visit 2
.002 high intensity drinking days/meas. days
Standard Deviation .015
.002 high intensity drinking days/meas. days
Standard Deviation .015
Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
Visit 4 (5 mo follow up)
.004 high intensity drinking days/meas. days
Standard Deviation .027
.005 high intensity drinking days/meas. days
Standard Deviation .028
Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
Visit 6 (17 mo follow up)
.007 high intensity drinking days/meas. days
Standard Deviation .031
.004 high intensity drinking days/meas. days
Standard Deviation .018

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Alcohol-related Problems (AUDIT-P) Score
Baseline
0.937 AUDIT-P score
Standard Deviation 2.208
1.116 AUDIT-P score
Standard Deviation 2.342
Alcohol-related Problems (AUDIT-P) Score
Visit 2
1.448 AUDIT-P score
Standard Deviation 2.911
1.095 AUDIT-P score
Standard Deviation 2.296
Alcohol-related Problems (AUDIT-P) Score
Visit 3
1.613 AUDIT-P score
Standard Deviation 3.288
1.389 AUDIT-P score
Standard Deviation 3.169
Alcohol-related Problems (AUDIT-P) Score
Visit 4 (5-mo follow up)
2.019 AUDIT-P score
Standard Deviation 3.755
1.605 AUDIT-P score
Standard Deviation 3.117
Alcohol-related Problems (AUDIT-P) Score
Visit 5 (17-mo follow up)
2.156 AUDIT-P score
Standard Deviation 3.587
1.596 AUDIT-P score
Standard Deviation 3.708

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
Baseline
.214 Proportion students w hazardous drinking
Standard Deviation .441
.159 Proportion students w hazardous drinking
Standard Deviation .366
Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
Visit 2
.230 Proportion students w hazardous drinking
Standard Deviation .421
.179 Proportion students w hazardous drinking
Standard Deviation .384
Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
Visit 3
.277 Proportion students w hazardous drinking
Standard Deviation .448
.211 Proportion students w hazardous drinking
Standard Deviation .409
Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
Visit 4 (5-mo follow up)
.262 Proportion students w hazardous drinking
Standard Deviation .441
.256 Proportion students w hazardous drinking
Standard Deviation .438
Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
Visit 5 (17-mo follow up)
.318 Proportion students w hazardous drinking
Standard Deviation .467
.192 Proportion students w hazardous drinking
Standard Deviation .395

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Depression
Baseline
3.053 DASS-D score
Standard Deviation 3.718
3.228 DASS-D score
Standard Deviation 3.924
Depression
Visit 2
3.607 DASS-D score
Standard Deviation 4.218
3.260 DASS-D score
Standard Deviation 3.974
Depression
Visit 3
3.817 DASS-D score
Standard Deviation 4.386
3.644 DASS-D score
Standard Deviation 4.137
Depression
Visit 4 (5-mo follow up)
3.854 DASS-D score
Standard Deviation 4.293
4.227 DASS-D score
Standard Deviation 4.613
Depression
Visit 5 (17-mo follow up)
4.000 DASS-D score
Standard Deviation 4.024
4.014 DASS-D score
Standard Deviation 4.488

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Binge Eating
Visit 3
5.423 EPSI binge eating score
Standard Deviation 5.585
5.233 EPSI binge eating score
Standard Deviation 5.167
Binge Eating
Baseline
7.243 EPSI binge eating score
Standard Deviation 6.105
6.541 EPSI binge eating score
Standard Deviation 5.354
Binge Eating
Visit 2
6.392 EPSI binge eating score
Standard Deviation 5.679
5.870 EPSI binge eating score
Standard Deviation 5.467
Binge Eating
Visit 4 (5-mo follow up)
6.079 EPSI binge eating score
Standard Deviation 5.595
5.800 EPSI binge eating score
Standard Deviation 5.805
Binge Eating
Visit 5 (17-mo follow up)
6.693 EPSI binge eating score
Standard Deviation 5.981
5.706 EPSI binge eating score
Standard Deviation 4.927

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Stress
Baseline
4.821 DASS-S score
Standard Deviation 3.776
4.691 DASS-S score
Standard Deviation 3.984
Stress
Visit 2
4.533 DASS-S score
Standard Deviation 3.857
4.669 DASS-S score
Standard Deviation 4.191
Stress
Visit 3
4.515 DASS-S score
Standard Deviation 4.289
4.571 DASS-S score
Standard Deviation 4.486
Stress
Visit 4 (5-mo follow up)
4.757 DASS-S score
Standard Deviation 4.238
5.151 DASS-S score
Standard Deviation 4.500
Stress
Visit 5 (17-mo follow up)
5.432 DASS-S score
Standard Deviation 4.461
5.082 DASS-S score
Standard Deviation 4.319

OTHER_PRE_SPECIFIED outcome

Timeframe: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

Delay discounting was calculated from a computer adjusting delay discounting task that asked participants to choose between smaller immediate rewards and larger, delayed rewards. The reward used in the task was hypothetical money. Mazur's hyperbolic function, V = A/ 1 + kD, was used to estimate each participant's delay discounting rate (i.e., k) for use in analyses. For this formula, V is the discounted value of a delayed reward (i.e., indifference point), A is the reward amount, D is the delay in days, and k represents the estimated delay discounting rate. Greater k values indicated stronger discounting and a preference for immediate monetary rewards. K values across the sample ranged from -11.06 to 2.43. Negative values generally indicate stronger discounting, whereas positive values typically represent less steep discounting.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Delay Discounting Rate
Baseline
-5.114 k value
Standard Deviation 2.122
-4.767 k value
Standard Deviation 2.210
Delay Discounting Rate
Visit 2
-5.204 k value
Standard Deviation 2.512
-5.215 k value
Standard Deviation 2.577
Delay Discounting Rate
Visit 3
-5.192 k value
Standard Deviation 2.687
-5.582 k value
Standard Deviation 2.545

OTHER_PRE_SPECIFIED outcome

Timeframe: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

The Adolescent Reinforcement Survey Schedule - Alcohol Use Version assesses the frequency of past-month engagement in and enjoyment derived from 45 activities (Hallgren et al, 2016). Each question is posed twice - once to assess the frequency and enjoyment of the activity while using alcohol and the once to assess the frequency and enjoyment of the activity while not using alcohol. Items range from 0-4. Frequency and enjoyment items are summed to form respective scores. From these scales, two subscales are created for alcohol-related reinforcement and alcohol-free reinforcement, calculated as the cross product between frequency and enjoyment items for alcohol-related and alcohol-free questions. The two subscales were used to calculate the outcome, the total reinforcement ratio (TRR) between alcohol-related and alcohol-free reinforcement. The ratio has values between 0 and 1, with higher values indicating more relative enjoyment of activities when using alcohol.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Total Reinforcement Ratio (TRR) Between Alcohol-related and Alcohol-free Sources of Reinforcement
Baseline
.333 Total reinforcement ratio
Standard Deviation .168
.354 Total reinforcement ratio
Standard Deviation .158
Total Reinforcement Ratio (TRR) Between Alcohol-related and Alcohol-free Sources of Reinforcement
Visit 2
.339 Total reinforcement ratio
Standard Deviation .167
.343 Total reinforcement ratio
Standard Deviation .174
Total Reinforcement Ratio (TRR) Between Alcohol-related and Alcohol-free Sources of Reinforcement
Visit 3
.350 Total reinforcement ratio
Standard Deviation .160
.336 Total reinforcement ratio
Standard Deviation .167

OTHER_PRE_SPECIFIED outcome

Timeframe: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

Moderator: The Drinking Motives Questionnaire-Revised (DMQ-R) is designed to measure the relative frequency of drinking for four distinct reason motives: enhancement, social, conformity, and coping (Cooper, 1994; Cox \& Klinger, 1988). The study used the coping motives scale, which contains 5 items. Items are assessed on a Likert scale ranging from 1-5 and are summed for form a scale score, which higher scores indicating greater endorsement of drinking to cope with stress/distress. Outcome: The outcome used in the analysis was the Alcohol Use Disorder Identification Test (AUDIT) total score; we originally planned to use AUDIT-Consumption and AUDIT-Problems subscales for two separate analyses and outcomes (in parallel with other moderation analyses); however the models did not converge. Therefore, AUDIT total score was used as the outcome in analyses.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Moderation of Treatment Effects (AUDIT Total) Based on Coping-motivated Drinking
Baseline
4.049 AUDIT score
Standard Deviation 4.725
3.514 AUDIT score
Standard Deviation 4.400
Moderation of Treatment Effects (AUDIT Total) Based on Coping-motivated Drinking
Visit 2
4.615 AUDIT score
Standard Deviation 5.156
3.722 AUDIT score
Standard Deviation 4.621
Moderation of Treatment Effects (AUDIT Total) Based on Coping-motivated Drinking
Visit 3
4.821 AUDIT score
Standard Deviation 5.647
4.085 AUDIT score
Standard Deviation 5.054

OTHER_PRE_SPECIFIED outcome

Timeframe: GPA was available and assessed during post-treatment follow up at and 5 months (all participants) and 17 months (for participants in Years 1-3)

Academic performance was measured using participant self-reported grade point average (GPA). College freshmen first received their GPA in the spring semester of college, which was at the 5 month follow up. Thus, we examined whether there were significant differences in GPA across treatment and control conditions at 5 month adn 17 month follow ups.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
Male participants in the control condition
Grade Point Average (GPA)
Visit 4 (5-mo follow up)
3.141 Grade point average (GPA)
Standard Deviation 0.691
3.124 Grade point average (GPA)
Standard Deviation 0.873
Grade Point Average (GPA)
Visit 5 (17-mo follow up)
3.098 Grade point average (GPA)
Standard Deviation 0.714
3.057 Grade point average (GPA)
Standard Deviation 0.951

OTHER_PRE_SPECIFIED outcome

Timeframe: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

Population: Due to the very small number of individuals reporting sex as intersex, we did not have sufficient statistical power to include this group in the moderating analyses by sex. Therefore, only results for groups of male and female are reported herein.

The moderator used in analyses was sex. The outcome was the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) subscale score.

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
n=18 course_sections
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
n=18 course_sections
Male participants in the control condition
Moderation of Treatment Effects (AUDIT-C) by Sex
Visit 2
2.980 AUDIT-C score
Standard Deviation 2.742
2.614 AUDIT-C score
Standard Deviation 2.676
3.426 AUDIT-C score
Standard Deviation 3.361
2.653 AUDIT-C score
Standard Deviation 3.140
Moderation of Treatment Effects (AUDIT-C) by Sex
Visit 3
2.985 AUDIT-C score
Standard Deviation 2.780
2.658 AUDIT-C score
Standard Deviation 2.643
3.505 AUDIT-C score
Standard Deviation 3.343
2.800 AUDIT-C score
Standard Deviation 2.963
Moderation of Treatment Effects (AUDIT-C) by Sex
Baseline
2.669 AUDIT-C score
Standard Deviation 2.549
2.518 AUDIT-C score
Standard Deviation 2.549
3.272 AUDIT-C score
Standard Deviation 3.463
2.695 AUDIT-C score
Standard Deviation 3.070

OTHER_PRE_SPECIFIED outcome

Timeframe: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

Population: Due to the very small number of individuals reporting sex as intersex, we did not have sufficient statistical power to include this group in the moderating analyses by sex. Therefore, only results for groups of male and female are reported herein.

The moderator in the model was sex. The outcome was the Alcohol Use Disorder Identification Test-Problems (AUDIT-P) subscale score

Outcome measures

Outcome measures
Measure
Behavioral Activation Condition (BA)
n=18 course_sections
Course sections cluster-randomized to the Behavioral Activation intervention condition
Standard Orientation Control (SO)
n=18 course_sections
Courses were cluster-randomized to the standard orientation (SO) course condition
Sex Male - Behavioral Activation (BA) Condition
n=18 course_sections
Male participants in the treatment condition
Sex Male- Standard Orientation (SO) Condition
n=18 course_sections
Male participants in the control condition
Moderation of Treatment Effects (AUDIT-P) by Sex
Baseline
0.881 AUDIT-P score
Standard Deviation 2.105
0.896 AUDIT-P score
Standard Deviation 1.987
1.416 AUDIT-P score
Standard Deviation 2.591
1.017 AUDIT-P score
Standard Deviation 2.511
Moderation of Treatment Effects (AUDIT-P) by Sex
Visit 2
1.248 AUDIT-P score
Standard Deviation 2.610
1.078 AUDIT-P score
Standard Deviation 2.278
1.722 AUDIT-P score
Standard Deviation 3.275
1.153 AUDIT-P score
Standard Deviation 2.361
Moderation of Treatment Effects (AUDIT-P) by Sex
Visit 3
1.142 AUDIT-P score
Standard Deviation 2.438
1.181 AUDIT-P score
Standard Deviation 2.615
2.238 AUDIT-P score
Standard Deviation 4.087
1.758 AUDIT-P score
Standard Deviation 3.905

Adverse Events

Behavioral Activation Condition (BA)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Orientation Control (SO)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tera Fazzino, PhD, Principal Investigator

University of Kansas

Phone: 7858640062

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place