A Behavioral Activation Intervention Administered in a College Freshman Orientation Course
Primary Purpose
Alcohol; Use, Problem, Stress, Binge Eating
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
behavioral activation
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol; Use, Problem focused on measuring behavioral activation, prevention, reinforcement, college students
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
Sites / Locations
- University of KansasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Behavioral Activation Course
Standard Orientation Course
Arm Description
Behavioral activation course condition administered in a college freshman orientation seminar
Standard freshman orientation seminar course condition
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04038190
First Posted
June 27, 2019
Last Updated
July 21, 2023
Sponsor
University of Kansas
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04038190
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol; Use, Problem, Stress, Binge Eating, Depression
Keywords
behavioral activation, prevention, reinforcement, college students
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Activation Course
Arm Type
Experimental
Arm Description
Behavioral activation course condition administered in a college freshman orientation seminar
Arm Title
Standard Orientation Course
Arm Type
No Intervention
Arm Description
Standard freshman orientation seminar course condition
Intervention Type
Behavioral
Intervention Name(s)
behavioral activation
Intervention Description
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).
Primary Outcome Measure Information:
Title
alcohol consumption
Description
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.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Title
high-intensity drinking (2+ times in excess of NIAAA low risk drinking guidelines for males and females)
Description
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.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Title
alcohol-related problems
Description
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.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Title
exceeding clinical cutoff of 8+ for hazardous/harmful drinking
Description
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.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Secondary Outcome Measure Information:
Title
depression
Description
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.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Title
binge eating
Description
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.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Title
stress
Description
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.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Other Pre-specified Outcome Measures:
Title
delay discounting
Description
Delay Discounting will be measured using a titrating binary choice task, which uses hypothetical money rewards to assess the degree to which a reward is discounted due to delay. The magnitude of the delayed monetary amount will be $50 and $200 available after a specified delay (1 day, 1 wk, 1 month, 6 months, 1 yr, 5 yrs). Subjects will indicate if they prefer the immediate amount of money or the alternative with a mouse-click and the computerized algorithm will adjust the immediate reward over 6 trials to determine an indifference point for each amount/delay pairing. Indifference points will be used to calculate a delay-discount rate. Higher delay discount rates indicate strong discounting and a preference for immediate rewards.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Title
reinforcement from alcohol-related and alcohol-free activities
Description
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 are 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.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Title
coping-motivated drinking
Description
The Drinking Motives Questionnaire-Revised (DMQ-R) designed to measure the relative frequency of drinking for four distinct reason motives: enhancement, social, conformity, and coping (Cooper, 1994; Cox & Klinger, 1988). The measure produces four scales that correspond with the four motives. The present study will use 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 frequency in coping-motivated drinking.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Title
grade point average (GPA)
Description
Academic performance will be measured using participate grade point average (GPA).
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
Title
alcohol violations on campus
Description
Participants alcohol violations at the University of Kansas will be documented at each time point.
Time Frame
baseline, 2 months, 4 months, and 8 months; 17 months for participants in Years 1-2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tera L Fazzino, PhD
Phone
7858640062
Email
tfazzino@ku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Yi, PhD
Email
ryi1@ku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tera L Fazzino, PhD
Organizational Affiliation
University of Kansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66046
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tera L Fazzino
Phone
785-864-0062
Email
tfazzino@ku.edu
First Name & Middle Initial & Last Name & Degree
Richard Yi
Phone
785-864-6476
Email
ryi1@ku.edu
First Name & Middle Initial & Last Name & Degree
Tera L Fazzino, PhD
First Name & Middle Initial & Last Name & Degree
Richard Yi, PhD
First Name & Middle Initial & Last Name & Degree
Carl W Lejuez, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
37583941
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.
Results Reference
background
PubMed Identifier
31982647
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.
Results Reference
result
PubMed Identifier
36833579
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.
Results Reference
result
Learn more about this trial
A Behavioral Activation Intervention Administered in a College Freshman Orientation Course
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