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Pilot Study on Training Emerging Adults Skills in Navigating College (SINC)

Primary Purpose

Alcohol Abuse, Cognitive Deficit in Attention

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Koru Mindfulness (KM) Training
Navigating College (NC) Training
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse focused on measuring Attentional Bias, Alcohol Misuse, Emerging Adults, Mindfulness Meditation

Eligibility Criteria

18 Years - 19 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • High school educated; college enrolled first-year student
  • Medically healthy
  • Ages 18-19
  • Native-English speaker (or fluent < 7 years old)
  • Self-report of >4 lifetime binge drinking episodes (>4 drinks/2hours for females, >5 drinks/2 hours for males).

Exclusion Criteria:

  • Psychiatric disease (such as depression or psychosis) using the MINI [25]
  • Systemic disease such as cancer, cardiovascular or inflammatory disease which could influence cognitive functioning
  • Motor or visual disturbance (e.g., colorblind)
  • Current use of psychoactive drugs (aside from moderate caffeine or alcohol), including prescription medications, or individuals with a known history of any substance use disorders (not including alcohol; including nicotine) or desire to seek treatment for excess substance (not including alcohol) use.

Sites / Locations

  • University of North Carolina at Chapel HillRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Navigating College (NC) Training

Koru Mindfulness (KM) Training

Arm Description

Control Group

Study Group

Outcomes

Primary Outcome Measures

Participant retention
Participant retention will be measured by the percentage of participants remaining in the study after 6 visits.
Compliance with independent training of skills
To determine participant compliance with training skills learned during each of the 4 virtual visits, the total number of journal entries logged during the 4 weeks of training is calculated as a total score. Total scores range from 0 to 24, with higher scores indicating greater compliance with independent training.

Secondary Outcome Measures

Expectancy of interventions
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item questionnaire composed of two self-report scales that measure the the credibility and expectancy of an intervention in clinical studies. The word "therapy" is replaced with "intervention" and modified to reflect the intent of the intervention (i.e., to improve skills in navigating college). Four items are rated on a 1-9 Likert-type scale (0=not at all, to 9=very much), and two items are rated on a Likert-type percentage scale (0 to 100%). Credibility ratings are calculated by taking the mean of the first three items of the CEQ, and expectancy rating is calculated by taking the score from one question.
Emotional distress
The Depression, Anxiety and Stress Scale-21 (DASS-21) is composed of three self-report scales that measure depression, anxiety and stress. Items are rated on a Likert-type scale (0=Did not apply to me at all, to 3=Applied to me very much, or most of the time). Scores for the three subscales are calculated by summing the scores for the relevant items. The severity rating for Depression are Normal: 0-4, Mild: 5-6, Moderate: 7-10, Severe: 11-13, and Extremely Severe: 14-21; for Stress the ratings are Normal: 0-7, Mild: 8-9, Moderate: 10-12, Severe: 13-16, and Extremely Severe 17-21; and for Anxiety the ratings are Normal: 0-3, Mild: 4-5, Moderate: 6-7, Severe: 8-9, and Extremely Severe: 10-21. The total DASS-21 score is calculated by summing all three subscales, with a range from 0-63. For all scales, higher scores indicate greater emotional distress.

Full Information

First Posted
September 26, 2022
Last Updated
September 14, 2023
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT05560425
Brief Title
Pilot Study on Training Emerging Adults Skills in Navigating College
Acronym
SINC
Official Title
Pilot Study on Mindfulness Meditation and Behavioral Flexibility Among Emerging Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lifetime risk for developing an alcohol use disorder increases with earlier onset of alcohol consumption. This risk may reflect a tendency for escalated alcohol intake among youth due to immature executive control, leading to more frequent binge drinking, which is associated with more alcohol-related problems. Binge drinking is associated with deficits in behavioral flexibility, which may suggest impaired control networks that contribute to automatic behavior. Individuals with an alcohol or substance use disorder (A/SUD) exhibit attentional bias toward drug- or alcohol-related stimuli that have attained salience through consistent use. Reward history increases attention towards non-drug stimuli, even among individuals with no lifetime A/SUD. Preliminary data (from Dr. Boettiger's lab) from a nationally representative US adult sample using data collected via Prolific found that a questionnaire measure of mindfulness moderates the relationship between alcohol misuse and attention to reward. Given evidence that heavy alcohol drinking impairs behavioral flexibility, which in turn promotes escalating intake, insight into the relationship between mindfulness and behavioral flexibility could inspire new strategies to prevent alcohol and substance use disorders in people at elevated risk.
Detailed Description
This is a feasibility pilot study of training freshman college students, with a history of alcohol binge drinking, mindfulness and meditation skills in 4 virtual visits. Before and after the virtual intervention, behavioral flexibility will be measured using a reward-driven attentional bias (Reward-AB) computerized task, and C-reactive protein (CRP) levels will be collected. Upon arrival for the first visit, participants will be screened for any current alcohol intoxication or recent substance use, followed by a mental health assessment with the Mini-International Neuropsychiatric Interview (MINI). The participant will then have blood collected by finger prick, complete a Reward-AB task, and fill out some paper surveys. During visits 2 through 5, participants will complete virtual training on either mindfulness and meditation skills, or navigating college skills. Each visit will last approximately 90 minutes, starting with the completion of a few online surveys. Visit 6 is similar to visit 1, without the health interview. Participants will be contacted one month following the date of the 6th study visit to complete online surveys. Visit 1: Written consent, MINI interview, urine drug screen and breathalyzer alcohol test, CRP assay, Reward-AB task. Randomization to either the Koru Mindfulness (KM) intervention or the Navigating College (NC) control group. Visits 2-5: Surveys completed online through REDCap. 75 minutes of instructor-led discussion Breakout sessions for participants to share thoughts and experiences in response to instructor's prompt. Visit 6: Similar to visit 1, without repeating the MINI interview. Follow-up: One month after the conclusion of visit 6, participants will be contacted via email with a link to REDCap to complete several surveys. Reward-Attentional Bias (Reward-AB) Task: This computerized task will be used to measure attentional bias pre- and post-intervention. The task includes a training and testing portion, each of which are adapted from tasks that measure the influence of reward on visual attention. Navigating College (NC) Control Group Training: Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); Hungry, Angry, Lonely, and Tired (HALT), gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Koru Mindfulness (KM) Intervention Training: Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4). Daily Logging of Skills: Participants in the NC intervention will be asked to journal by hand or via Qualtrics every day for >10 minutes, on anything related to the topics learned during that week's training visit. Participants in the KM intervention will be asked to practice every day for >10 minutes any mindfulness or meditation skill previously learned during training visits, in addition to logging practice of skills and reflection on the experience using the Koru application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Cognitive Deficit in Attention
Keywords
Attentional Bias, Alcohol Misuse, Emerging Adults, Mindfulness Meditation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment randomized controlled trial feasibility study
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Navigating College (NC) Training
Arm Type
Active Comparator
Arm Description
Control Group
Arm Title
Koru Mindfulness (KM) Training
Arm Type
Experimental
Arm Description
Study Group
Intervention Type
Behavioral
Intervention Name(s)
Koru Mindfulness (KM) Training
Other Intervention Name(s)
Koru Basic
Intervention Description
The Koru Basic curriculum consists of four weekly interactive 75-minute classes delivered online through Zoom. Each class consists of an overview of 2-3 skills, group practice of the skills, and group reflection. Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4). Participants are instructed to practice a skill for 10 minutes/day and log any reflection on that practice using the Koru phone application.
Intervention Type
Behavioral
Intervention Name(s)
Navigating College (NC) Training
Intervention Description
With topics discussed from the Freshman Survival Guide book, this training provides a closely matched active control group for KM Training. The training consists of four weekly 75-minute classes delivered online through Zoom. Each class consists of lecture and group discussions on topics related to navigating college. Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); HALT, gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Participants are instructed to journal about learned information and skills for 10 minutes/day.
Primary Outcome Measure Information:
Title
Participant retention
Description
Participant retention will be measured by the percentage of participants remaining in the study after 6 visits.
Time Frame
10 weeks
Title
Compliance with independent training of skills
Description
To determine participant compliance with training skills learned during each of the 4 virtual visits, the total number of journal entries logged during the 4 weeks of training is calculated as a total score. Total scores range from 0 to 24, with higher scores indicating greater compliance with independent training.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Expectancy of interventions
Description
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item questionnaire composed of two self-report scales that measure the the credibility and expectancy of an intervention in clinical studies. The word "therapy" is replaced with "intervention" and modified to reflect the intent of the intervention (i.e., to improve skills in navigating college). Four items are rated on a 1-9 Likert-type scale (0=not at all, to 9=very much), and two items are rated on a Likert-type percentage scale (0 to 100%). Credibility ratings are calculated by taking the mean of the first three items of the CEQ, and expectancy rating is calculated by taking the score from one question.
Time Frame
1 week
Title
Emotional distress
Description
The Depression, Anxiety and Stress Scale-21 (DASS-21) is composed of three self-report scales that measure depression, anxiety and stress. Items are rated on a Likert-type scale (0=Did not apply to me at all, to 3=Applied to me very much, or most of the time). Scores for the three subscales are calculated by summing the scores for the relevant items. The severity rating for Depression are Normal: 0-4, Mild: 5-6, Moderate: 7-10, Severe: 11-13, and Extremely Severe: 14-21; for Stress the ratings are Normal: 0-7, Mild: 8-9, Moderate: 10-12, Severe: 13-16, and Extremely Severe 17-21; and for Anxiety the ratings are Normal: 0-3, Mild: 4-5, Moderate: 6-7, Severe: 8-9, and Extremely Severe: 10-21. The total DASS-21 score is calculated by summing all three subscales, with a range from 0-63. For all scales, higher scores indicate greater emotional distress.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: High school educated; college enrolled first-year student Medically healthy Ages 18-19 Native-English speaker (or fluent < 7 years old) Self-report of >4 lifetime binge drinking episodes (>4 drinks/2hours for females, >5 drinks/2 hours for males). Exclusion Criteria: Psychiatric disease (such as depression or psychosis) using the MINI [25] Systemic disease such as cancer, cardiovascular or inflammatory disease which could influence cognitive functioning Motor or visual disturbance (e.g., colorblind) Current use of psychoactive drugs (aside from moderate caffeine or alcohol), including prescription medications, or individuals with a known history of any substance use disorders (not including alcohol; including nicotine) or desire to seek treatment for excess substance (not including alcohol) use.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Boettiger, PhD
Phone
919.907.0585
Email
cab@unc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Boettiger, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-3270
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Boettiger, PhD
Phone
919-907-0585
Email
cab@unc.edu
First Name & Middle Initial & Last Name & Degree
Charlotte Boettiger, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).
IPD Sharing Time Frame
beginning 9 and continuing for 36 months following publication
IPD Sharing Access Criteria
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Citations:
PubMed Identifier
29467469
Citation
Spear LP. Effects of adolescent alcohol consumption on the brain and behaviour. Nat Rev Neurosci. 2018 Apr;19(4):197-214. doi: 10.1038/nrn.2018.10. Epub 2018 Feb 15. Erratum In: Nat Rev Neurosci. 2018 May 15;:
Results Reference
background
PubMed Identifier
740823
Citation
Mehrabian A, Russell JA. A questionnaire measure of habitual alcohol use. Psychol Rep. 1978 Dec;43(3 Pt 1):803-6. doi: 10.2466/pr0.1978.43.3.803. No abstract available.
Results Reference
background
PubMed Identifier
24820536
Citation
Gass JT, Glen WB Jr, McGonigal JT, Trantham-Davidson H, Lopez MF, Randall PK, Yaxley R, Floresco SB, Chandler LJ. Adolescent alcohol exposure reduces behavioral flexibility, promotes disinhibition, and increases resistance to extinction of ethanol self-administration in adulthood. Neuropsychopharmacology. 2014 Oct;39(11):2570-83. doi: 10.1038/npp.2014.109. Epub 2014 May 13.
Results Reference
background
PubMed Identifier
31319133
Citation
Sey NYA, Gomez-A A, Madayag AC, Boettiger CA, Robinson DL. Adolescent intermittent ethanol impairs behavioral flexibility in a rat foraging task in adulthood. Behav Brain Res. 2019 Nov 5;373:112085. doi: 10.1016/j.bbr.2019.112085. Epub 2019 Jul 15.
Results Reference
background
PubMed Identifier
20668841
Citation
Chanon VW, Sours CR, Boettiger CA. Attentional bias toward cigarette cues in active smokers. Psychopharmacology (Berl). 2010 Oct;212(3):309-20. doi: 10.1007/s00213-010-1953-1. Epub 2010 Jul 29.
Results Reference
background
PubMed Identifier
23663386
Citation
Field M, Marhe R, Franken IH. The clinical relevance of attentional bias in substance use disorders. CNS Spectr. 2014 Jun;19(3):225-30. doi: 10.1017/S1092852913000321. Epub 2013 May 13.
Results Reference
background
PubMed Identifier
27505196
Citation
Field M, Werthmann J, Franken I, Hofmann W, Hogarth L, Roefs A. The role of attentional bias in obesity and addiction. Health Psychol. 2016 Aug;35(8):767-80. doi: 10.1037/hea0000405.
Results Reference
background
PubMed Identifier
31354446
Citation
Masiero M, Lucchiari C, Maisonneuve P, Pravettoni G, Veronesi G, Mazzocco K. The Attentional Bias in Current and Former Smokers. Front Behav Neurosci. 2019 Jul 10;13:154. doi: 10.3389/fnbeh.2019.00154. eCollection 2019.
Results Reference
background
PubMed Identifier
32935290
Citation
Meyer KN, Sheridan MA, Hopfinger JB. Reward history impacts attentional orienting and inhibitory control on untrained tasks. Atten Percept Psychophys. 2020 Nov;82(8):3842-3862. doi: 10.3758/s13414-020-02130-y.
Results Reference
background
PubMed Identifier
24499130
Citation
Greeson JM, Juberg MK, Maytan M, James K, Rogers H. A randomized controlled trial of Koru: a mindfulness program for college students and other emerging adults. J Am Coll Health. 2014;62(4):222-33. doi: 10.1080/07448481.2014.887571.
Results Reference
background
PubMed Identifier
21646524
Citation
Anderson BA, Laurent PA, Yantis S. Value-driven attentional capture. Proc Natl Acad Sci U S A. 2011 Jun 21;108(25):10367-71. doi: 10.1073/pnas.1104047108. Epub 2011 Jun 6.
Results Reference
background
PubMed Identifier
31190092
Citation
Anderson BA, Kim H, Britton MK, Kim AJ. Measuring attention to reward as an individual trait: the value-driven attention questionnaire (VDAQ). Psychol Res. 2020 Nov;84(8):2122-2137. doi: 10.1007/s00426-019-01212-3. Epub 2019 Jun 12.
Results Reference
background
PubMed Identifier
17899351
Citation
Carmody J, Baer RA. Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms and well-being in a mindfulness-based stress reduction program. J Behav Med. 2008 Feb;31(1):23-33. doi: 10.1007/s10865-007-9130-7. Epub 2007 Sep 25.
Results Reference
background

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Pilot Study on Training Emerging Adults Skills in Navigating College

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