Alcohol PBS and Thinking About the Past
Alcohol Protective Behavioral Strategies and Thinking About the Past
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Rachel Smallman
- Phone Number: 979-845-3983
- Email: rsmallman@tamu.edu
Study Contact Backup
- Name: Sherecce Fields
- Phone Number: 979-845-3774
- Email: safields@tamu.edu
Study Locations
-
-
Texas
-
College Station, Texas, United States, 77843
- Texas A&M University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- minimum age of 18 years
Exclusion Criteria:
- no exclusions at baseline
- participants who do not follow the instructions for the specific writing task will be unable to sign-up for the remaining follow up sessions (Parts 2-6) and will be excluded the final data analyses
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Negative Event Only
Participants will be asked to think of a specific example of the most (or one of the most) negative, unpleasant event with alcohol they have experienced; the event they choose must have occurred at least a year ago.
Or they will be asked to think of the most significant event that has occurred in the past year.
After thinking of a specific event, they will be given three minutes to write about their experience.
The writing prompt will ask that they express the event information in a few sentences.
This writing prompt will help participants place themselves back into that moment and access salient emotions and cognition about it.
Similar negative event prompts have been used in counterfactual thinking studies (McFarland & Alvaro, 2000; White & Lehman, 2005).
|
Participants are asked to write about a negative event related to alcohol and write about it
|
|
Active Comparator: Negative Event + Factual Thinking Task
Participants in this group, the event plus the factual thinking task condition, will be told the following after completing the negative event writing task, "After disappointing and/or negative experiences like the one you described on the previous page, people often think about the details of the situation.
For example, when it happened, who was involved, and what happened right before or after the incident occurred.
In the space below please provide examples of some of these details.."
There will be 10 blank boxes below the instructions and participants will be asked to provide some examples of details from their traumatic event.
They will be asked to only list as many as they can naturally recall without repeating any.
This procedure is derived from Kray and colleague's (2010) study on counterfactual thinking and meaning in life.
|
Active Control condition where participants write about a negative event and list three facts about it
|
|
Experimental: Negative Event + Counterfactual Task
Participants will be told after completing the negative event writing task, "After disappointing and/or negative experiences like the one you described, people sometimes cannot help thinking "what if…" or "if only…" and imagining how things might have gone differently.
That is, if only I had done something differently, the negative drinking situation could have been avoided or turned out better.
In the box below please identify things that, had they been different, would have improved the outcome of the negative drinking situation you described earlier and briefly describe how the outcome would have been better."
Participants will be asked to list three counterfactuals about the event.
Participants will also be asked to think of situations where these strategies could be used, to list out any obstacles that might prevent them from implementing these strategies and to indicate their intention to use each strategy over the next week.
|
Participants will complete a counterfactual based intervention where they come up with three if only..then statements about how a past drinking behavior could have been altered to be better and to think about protective behavioral strategies that they could use in a future similar situation to make the outcome better.
|
|
Experimental: Personalized Normative Feedback
Participants in this group, the personalized normative feedback, will be asked to rate the frequency and quantity of TAMU students that use PBS when drinking.
|
Participants will be asked to rate the frequency and quantity of students who use protective behavioral strategies while drinking.
They will be given feedback on how close their estimate is from the national averages.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Protective Behavioral Strategies-20
Time Frame: Weeks 1 - 6
|
The Protective Behavioral Strategy-20 measure is a 20-item questionnaire assessing the use of three types of Protective Behavioral Strategies: serious harm reduction (8 items), stopping/limiting drinking (7 items), and manner of drinking (5 items).
Each item has response options consisting of 1 (Never), 2 (Rarely), 3 (Occasionally), 4 (Sometimes), 5 (Usually), 6 (Always); there is also a Do not wish to respond option.
Protective Behavioral Strategy Use scores are average scores for each subscale, with minimum scores of 0 and maximum scores of 6.
Higher scores indicate greater use of protective behavioral strategies.
|
Weeks 1 - 6
|
|
Young Adult Alcohol Consequences Questionnaire
Time Frame: Week 1
|
The Young Adult Alcohol Consequences Questionnaire is a 48-item questionnaire assessing problems from alcohol consumption within the last three months.
Each item is categorized into one of eight problem domains: social/interpersonal, academic/occupational, risky behavior, impaired control, poor self-care, diminished self-perception, blackout drinking, and physiological dependence.
For each item, participants select Yes, No, or Do not wish to respond to indicate whether they have experienced each problem from alcohol consumption (e.g., "I have become very rude, obnoxious or insulting after drinking").
If a participant selects Yes that is indicative of the participant having experienced that specific consequence from alcohol consumption.
|
Week 1
|
|
Alcohol Use Contemplation to Change Ladder
Time Frame: Week 1
|
To assess an individual's contemplation to change their alcohol drinking behavior, a Contemplation to Change Ladder (Biener & Abrams, 1991) will be used.
This ladder displays response options on a ladder graphic, with rungs starting at 0 and ending at 10; each rung increases by one point value as you go up the ladder.
Anchors with text descriptions are located at points 0 (No thought of quitting), 2 (Think I need to consider quitting someday), 5 (Think I should quit but not quite ready), 8 (Starting to think about how to change my drinking patterns), and 10 (Taking action to quit e.g., cutting down, enrolling in a program).
The higher a participant selects a rung on the ladder, the higher the contemplation to change their alcohol drinking behavior.
|
Week 1
|
|
Change in Indication of Drinking and Strategy Use
Time Frame: Week 2 - Week 6
|
A measure that assesses an individual's ability to avoid alcohol if they wanted to as well as binge-drinking or the ability to drink less in the next week
|
Week 2 - Week 6
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Perceived Behavioral Control
Time Frame: Week 1 and Week 2
|
The Perceived Behavioral Control questionnaire measure is made up of six items.
Three items assess the individual's ability to avoid alcohol if they wanted to and three items assess binge-drinking or the ability to drink less than 7(females) or 10 (males) units in a single session in the next week.
Each item is scored on separate 7-point bipolar adjective scales (e.g., "For me to avoid drinking alcohol is…" very difficult to very easy).
The six items will be averaged together to obtain an overall score for Perceived Behavioral Control.
Higher scores indicate greater perceived behavioral control to control drinking behavior.
|
Week 1 and Week 2
|
|
Change in Delay Discounting
Time Frame: Week 1, Week 4 and Week 6
|
A measure of the amount participants discount delayed rewards
|
Week 1, Week 4 and Week 6
|
|
Change in Counterfactual Use and Intentions
Time Frame: Week 2 - Week 6
|
Participants responses about whether they did counterfactuals in the past week and their intentions to use those behaviors in the next week.
|
Week 2 - Week 6
|
|
Change in Personal Assessment of Responsible Drinker Identity Scale
Time Frame: Week 1, Week 4 and Week 6
|
Participants are asked to indicate how true each statement in the Personal Assessment of Responsible Drinker Identity Scale is of the participant's experiences overall.
Each item of this measure has response options ranging from 1 (not at all true) to 5 (completely true).
Higher scores reflect greater agreement with identifying as a responsible drinker.
|
Week 1, Week 4 and Week 6
|
|
Change in Perceptions of Protective Behavioral Strategies
Time Frame: Week 1 - Week 6
|
Questions about the percentage and frequency of use of protective behavioral strategies among college students.
|
Week 1 - Week 6
|
|
Change in Contemplation to Change Ladder
Time Frame: Week 1 and Week 2
|
To assess an individual's contemplation to change their alcohol drinking behavior, a Contemplation to Change Ladder (Biener & Abrams, 1991) will be used.
This ladder displays response options on a ladder graphic, with rungs starting at 0 and ending at 10; each rung increases by one point value as you go up the ladder.
Anchors with text descriptions are located at points 0 (No thought of quitting), 2 (Think I need to consider quitting someday), 5 (Think I should quit but not quite ready), 8 (Starting to think about how to change my drinking patterns), and 10 (Taking action to quit e.g., cutting down, enrolling in a program).
The higher a participant selects a rung on the ladder, the higher the contemplation to change their alcohol drinking behavior.
|
Week 1 and Week 2
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Rob Dvorak, PhD, University of Central Florida
- Principal Investigator: Rachel Smallman, PhD, Texas A&M University
- Principal Investigator: Sherecce Fields, PhD, Texas A&M University
Publications and helpful links
General Publications
- Ajzen, I., & Sheikh, S. (2013). Action versus inaction: Anticipated affect in the theory of planned behavior. Journal of Applied Social Psychology, 43(1), 155-162. https://doi.org/10.1111/j.1559-1816.2012.00989.x
- Cooke R, Sniehotta F, Schuz B. Predicting binge-drinking behaviour using an extended TPB: examining the impact of anticipated regret and descriptive norms. Alcohol Alcohol. 2007 Mar-Apr;42(2):84-91. doi: 10.1093/alcalc/agl115. Epub 2006 Dec 21.
- Coolidge T, Skaret E, Heima M, Johnson EK, Hillstead MB, Farjo N, Asmyhr O, Weinstein P. Thinking about going to the dentist: a Contemplation Ladder to assess dentally-avoidant individuals' readiness to go to a dentist. BMC Oral Health. 2011 Jan 27;11:4. doi: 10.1186/1472-6831-11-4.
- Epstude K, Roese NJ. The functional theory of counterfactual thinking. Pers Soc Psychol Rev. 2008 May;12(2):168-92. doi: 10.1177/1088868308316091.
- Hogue A, Dauber S, Morgenstern J. Validation of a contemplation ladder in an adult substance use disorder sample. Psychol Addict Behav. 2010 Mar;24(1):137-44. doi: 10.1037/a0017895.
- McGee R, Williams S, Kypri K. College students' readiness to reduce binge drinking: criterion validity of a brief measure. Drug Alcohol Depend. 2010 Jun 1;109(1-3):236-8. doi: 10.1016/j.drugalcdep.2009.12.009. Epub 2010 Jan 27.
- Roese, N. J., Epstude, K. (2017). The functional theory of counterfactual thinking: New evidence, new challenges, new insights. Advances in Experimental Social Psychology, 56, 1-79.
- Smallman R, Roese NJ. Counterfactual Thinking Facilitates Behavioral Intentions. J Exp Soc Psychol. 2009 Jul;45(4):845-852. doi: 10.1016/j.jesp.2009.03.002.
- Tal-Or, N., Boninger, D. S., & Gleicher, F. (2004). On becoming what we might have been: Counterfactual thinking and self-efficacy. Self and Identity, 3(1), 5-26.
- Wong, E. M. (2007). Narrating near-histories: The effects of counterfactual communication on motivation and performance. Management & Organizational History, 2(4), 351-370. https://doi.org/10.1177/1744935907086119
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IRB20201070D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.