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A Behavioral Activation Intervention Administered in a College Freshman Orientation Course

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ClinicalTrials.gov Identifier: NCT04038190
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Kansas

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.

Condition or disease Intervention/treatment Phase
Alcohol; Use, Problem Stress Binge Eating Depression Behavioral: behavioral activation Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Cluster-randomized Trial of a Behavioral Activation Intervention Administered in a College Freshman Orientation Course
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Experimental: Behavioral Activation Course
Behavioral activation course condition administered in a college freshman orientation seminar
Behavioral: behavioral 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).

No Intervention: Standard Orientation Course
Standard freshman orientation seminar course condition



Primary Outcome Measures :
  1. alcohol consumption [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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.

  2. high-intensity drinking (2+ times in excess of NIAAA low risk drinking guidelines for males and females) [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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.

  3. alcohol-related problems [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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.

  4. exceeding clinical cutoff of 8+ for hazardous/harmful drinking [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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 :
  1. depression [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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.

  2. binge eating [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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.

  3. stress [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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.


Other Outcome Measures:
  1. delay discounting [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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.

  2. reinforcement from alcohol-related and alcohol-free activities [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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.

  3. coping-motivated drinking [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    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.

  4. grade point average (GPA) [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    Academic performance will be measured using participate grade point average (GPA).

  5. alcohol violations on campus [ Time Frame: baseline, 2 months, 4 months, and 8 months; 17 months for random sample of 20% of participants ]
    Participants alcohol violations at the University of Kansas will be documented at each time point.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • College freshmen enrolled in UNIV 101 freshman seminar courses at the University of Kansas assigned to the study

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038190


Contacts
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Contact: Tera L Fazzino, PhD 7858640062 tfazzino@ku.edu
Contact: Richard Yi, PhD ryi1@ku.edu

Locations
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United States, Kansas
University of Kansas Recruiting
Lawrence, Kansas, United States, 66046
Contact: Tera L Fazzino    785-864-0062    tfazzino@ku.edu   
Contact: Richard Yi    785-864-6476    ryi1@ku.edu   
Principal Investigator: Tera L Fazzino, PhD         
Sub-Investigator: Richard Yi, PhD         
Sub-Investigator: Carl W Lejuez, PhD         
Sponsors and Collaborators
University of Kansas
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Tera L Fazzino, PhD University of Kansas

Publications of Results:

Other Publications:
Cooper, M. L. (1994). Motivations for alcohol use among adolescents: Development and validation of a four-factor model. Psychological Assessment, 6(2), 117-128. http://dx.doi.org/10.1037/1040-3590.6.2.117
Sobell, L. C., & Sobell, M. B. (1992). Timeline follow-back: A technique for assessing self-reported alcohol consumption. In R. Z. Litten & J. P. Allen (Eds.), Measuring alcohol consumption: Psychosocial and biochemical methods (pp. 41-72). Totowa, NJ, US: Humana Press. http://dx.doi.org/10.1007/978-1-4612-0357-5_3
Sobell LC ; Sobell MB. Alcohol Timeline Followback (TFLB). In: American Psychiatric Association (ed.). HANDBOOK OF PSYCHIATRIC MEASURES. Washington DC : American Psychiatric Association, 2000, pp. 477-479.

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Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT04038190     History of Changes
Other Study ID Numbers: STUDY00143954
1R01AA027791-01 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Kansas:
behavioral activation
prevention
reinforcement
college students
Additional relevant MeSH terms:
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Bulimia
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms