Pilot Study on Training Emerging Adults Skills in Navigating College

NCT05560425 | Completed Results

• 1 other identifier: 21-1486
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse; Cognitive Deficit in Attention

Keywords

Attentional Bias; Alcohol Misuse; Emerging Adults; Mindfulness Meditation

Outcome Measures

Primary Outcomes (2)

• Participant Retention

  Participant retention will be measured by the percentage of enrolled participants remaining in the study after 6 visits.

  10 weeks

• Compliance With Independent Training of Skills

  To determine participant compliance with training skills learned during each of the 4 virtual visits, the average number of journal entries logged during the 4 weeks of training, for each group, is calculated as a total score (6 times/week x 4 weeks = 24). Scores range from 0 to 24, with higher scores indicating greater compliance with independent training.

  6 weeks

Secondary Outcomes (4)

• Average CEQ Ratings - Credibility Subscale

  1 week

• Average CEQ Ratings - Expectancy Subscale

  1 week

• Mean Change in Emotional Distress Scores

  Baseline, Week 6

• Participant Satisfaction

  5 weeks

Study Arms (2)

Navigating College (NC) Training

ACTIVE COMPARATOR

Control Group

Behavioral: Navigating College (NC) Training

Koru Mindfulness (KM) Training

EXPERIMENTAL

Study Group

Behavioral: Koru Mindfulness (KM) Training

Interventions

Koru Mindfulness (KM) Training BEHAVIORAL

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.

Also known as: Koru Basic

Koru Mindfulness (KM) Training

Navigating College (NC) Training BEHAVIORAL

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.

Navigating College (NC) Training

Eligibility Criteria

• Age: 18 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-3270, United States

Location

Related Publications (13)

• 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.

  PMID: 29467469 BACKGROUND

• 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.

  PMID: 740823 BACKGROUND

• 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.

  PMID: 24820536 BACKGROUND

• 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.

  PMID: 31319133 BACKGROUND

• 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.

  PMID: 20668841 BACKGROUND

• 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.

  PMID: 23663386 BACKGROUND

• 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.

  PMID: 27505196 BACKGROUND

• 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.

  PMID: 31354446 BACKGROUND

• 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.

  PMID: 32935290 BACKGROUND

• 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.

  PMID: 24499130 BACKGROUND

• 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.

  PMID: 21646524 BACKGROUND

• 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.

  PMID: 31190092 BACKGROUND

• 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.

  PMID: 17899351 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Elena Vidrascu, PhD, MSc
• Organization: University of North Carolina at Chapel Hill

elena91@live.unc.edu

919-843-9193

Study Officials

• Charlotte Boettiger, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel assignment randomized controlled trial feasibility study

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: September 11, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)