The UniVenture Program

NCT05383989 | Unknown DMC

• 1 other identifier: 2021-5689
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 5

Brief Summary

UniVenture is a research partnership with one common goal: to adapt, test, and begin sharing an effective, sustainable, targeted wellness program to tackle the timely social issue of heavy drinking and other substance misuse on Canadian campuses. Our project is a 5-year, multi-site, controlled study involving 1st and 2nd year undergraduates at 5 representatively diverse Canadian university sites (Dalhousie University, St. Francis Xavier University, York University, Université de Montréal, and University of British Columbia-Okanagan). The investigator will test a program targeting personality traits linked to substance misuse. An earlier version of this program led to marked reductions in substance use and distress in adolescents. Our novel objectives are to examine the program's effects on substance use and distress among emerging adults; uptake of prescription drug use given the opioid crisis; and undergraduates' academic success. The investigator will carry out a randomized controlled trail in which two versions of the program will be assessed: a face-to-face and an innovative and accessible technology-assisted distance-delivery format, both compared to normal campus services alone. UniVenture may potentially have a dramatic effect on university policies on the prevention of substance misuse on Canadian campuses by helping partners appreciate the effectiveness of targeted and personalized approaches, and leveraging partners' expansive networks to inform other Canadian universities. A successful technology-assisted distance-delivered program will provide universities with an effective, relatively low-cost, and accessible tool to intervene with risky substance use behaviors in undergraduates. A successful program for at-risk students will also profoundly impact their academic performance and goal achievement, as well as their lives beyond university. Our partnership will impact knowledge sharing and student training opportunities. With a diversity of academic and non-academic partners and an integrative knowledge sharing approach, the investigator will share results with many audiences throughout the project. The academic researchers have recognized expertise in training and mentoring students. Further, trainees will be exposed to many opportunities and settings both inside and outside of the university in which to apply their research skills to substance misuse prevention.

Conditions

Anxiety Sensitivity; Hopelessness; Sensation Seeking; Impulsivity

Keywords

Substance misuse; Prevention; Personality; Knowledge mobilization; Well-being; Academic retention; Academic performance; Binge drinking; Emerging adulthood; Life transitions; Technology assisted programs; Student services

Outcome Measures

Primary Outcomes (3)

• Changes in alcohol-related harms in undergraduates

  Alcohol use as a continuous measure of alcohol-related harm. The Brief-Young Adult Alcohol Consequences Questionnaire (B-YAACQ) is a 24-item scale that will be used to measure changes in the experiences of alcohol-related harms in the past 3 months. The response options include (1) Yes, in the past 3 months, (2) Yes, but not in the past 3 months (3) No. This measure will be scored as the number of adverse consequences experienced in the last three months on a continuous scale from 0-24. \[Higher scores indicate greater adverse alcohol consequences\]

  Past 3 months

• Changes in cannabis-related harms in undergraduates

  Cannabis use as a continuous measure of cannabis-related harm. The Brief Marijuana Consequences Questionnaire (BMACQ) is a 21-item scale that will be used to measure changes in participants' reported experiences of cannabis-related harms in the past 3 months. The response options include (1) Yes, in the past 3 months, (2) Yes, but not in the past 3 months (3) No. This measure will be scored as the number of adverse consequences experienced in the last three months on a continuous scale from 0-21. \[Higher scores indicate greater adverse cannabis consequences\]

  Past 3 months

• Changes in the student wellbeing in undergraduates

  It will be measured by the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) - which combines the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scales - as a composite measure of depression and anxiety. Response option of Generalized Anxiety Disorder (GAD-7) is (1) Not at all (2) Several days (3) More than half of the days (4) Nearly every day. Response option of Patient Health Questionnaire (PHQ-9) is (1) Not at all (2) Several days (3) Over half the days (4) Nearly every day. \[Higher scores indicate higher mental wellbeing\]

  Past 3 months

Secondary Outcomes (5)

• Differences in semester GPA between treatment groups.

  Through study completion, an average of 1 year

• Changes in scores on the undergraduates' Academic retention measure

  Through study completion, an average of 1 year

• Changes in scores on the undergraduates' Academic challenges measure

  Past 2 weeks

• Changes in scores on the undergraduate self-regulated learning (SRL) behaviour measure and Self-efficacy beliefs for undergraduates' success measures

  Past 2 weeks

• Changes in score of hazardous drinkers in undergraduates

  Past 3 months

Study Arms (3)

UniVenture- face-to-face (in-person format)

EXPERIMENTAL

Personality-matched wellness program condition in face-to-face format (i.e., high AS student receives face-to-face AS program; high HOP student receives face-to-face HOP workshop: high SS student receives face-to-face SS workshop; high IMP student receives face-to-face IMP workshop)

Behavioral: UniVenture Hopelessness manual; Behavioral: UniVenture Anxiety Sensitivity manual; Behavioral: UniVenture Sensation Seeking manual; Behavioral: UniVenture Impulsivity manual

UniVenture- online (distance-delivery format)

ACTIVE COMPARATOR

Personality-matched wellness program condition in distance-delivery format (i.e., high AS student receives online (distance-delivered) AS workshop; high HOP student receives online (distance-delivered) HOP workshop: high SS student receives online (distance-delivered) SS workshop; high IMP student receives online (distance-delivered) IMP workshop

Behavioral: UniVenture Hopelessness manual; Behavioral: UniVenture Anxiety Sensitivity manual; Behavioral: UniVenture Sensation Seeking manual; Behavioral: UniVenture Impulsivity manual

UniVenture- service as usual (control)

PLACEBO COMPARATOR

Services-as-usual offered by the respective university

Behavioral: Service as usual provided by the University

Interventions

UniVenture Hopelessness manual BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Hopelessness (HOP) personality traits on the Substance Use Risk Profile Scale (SURPS).

UniVenture- face-to-face (in-person format); UniVenture- online (distance-delivery format)

UniVenture Anxiety Sensitivity manual BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Anxiety Sensitivity (AS) personality traits on the Substance Use Risk Profile Scale (SURPS).

UniVenture- face-to-face (in-person format); UniVenture- online (distance-delivery format)

UniVenture Sensation Seeking manual BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Sensation Seeking (SS) personality traits on the Substance Use Risk Profile Scale (SURPS)

UniVenture- face-to-face (in-person format); UniVenture- online (distance-delivery format)

UniVenture Impulsivity manual BEHAVIORAL

Intended for those who score at least 0.5 standard deviation (SD) above the population-specific norm on Impulsivity (IMP) personality traits on the Substance Use Risk Profile Scale (SURPS).

UniVenture- face-to-face (in-person format); UniVenture- online (distance-delivery format)

Service as usual provided by the University BEHAVIORAL

It is the regular university-provided well-being services.

UniVenture- service as usual (control)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• st and 2nd year undergraduate students (either part-time or full-time enrollment)
• Age between 18- 25 years
• Have used alcohol and/or cannabis and/or any other substance in the past 3 months,
• Score at least 0.5 standard deviation (SD) above the population-specific norm on 1 of 4 personality traits on the Substance Use Risk Profile Scale (SURPS) (i) Anxiety Sensitivity (AS) (ii) Hopelessness (HOP) (iii) Sensation Seeking (SS) and (iv) Impulsive (IMP)

You may not qualify if:

• Unwilling to participate

Sponsors & Collaborators

• Sherry Stewart: lead
• Dalhousie University: collaborator
• St. Francis Xavier University: collaborator
• Université de Montréal: collaborator
• York University: collaborator
• University of British Columbia: collaborator
• University of Victoria: collaborator
• Canadian Centre on Substance Use and Addiction (CCSA): collaborator
• Canadian Research Initiative in Substance Misuse: collaborator
• Injury Free Nova Scotia (IFNS): collaborator
• Mental Health Commission of Canada (MHCC): collaborator
• Postsecondary Education Partnership - Alcohol Harms (PEP-AH): collaborator
• Strategy for Patient Orientated Research: collaborator
• SHARP- Students for Healthy Alternatives & Risk Prevention: collaborator
• Nova Scotia Health Authority: collaborator

Study Sites (5)

University of British Columbia-Okanagan campus

Kelowna, British Columbia, Canada

RECRUITING

St. Francis Xavier University

Antigonish, Nova Scotia, Canada

RECRUITING

Dalhousie University

Halifax, Nova Scotia, Canada

RECRUITING

York University

Toronto, Ontario, Canada

RECRUITING

Université de Montréal

Montreal, Quebec, Canada

RECRUITING

Related Publications (18)

• Szalavitz, M. (2016, September 29). The 4 traits that put kids at risk for addiction. The New York Times. Retrieved from https://www.nytimes.com/2016/10/04/well/family/the-4-traits-that-put-kids-at- risk-for-addiction.html

  BACKGROUND

• Nair, R. (2017, January 22). Vernon, B. C. schools to pilot program that identifies addiction personality traits. CBC News. Retrieved from https://www.cbc.ca/news/canada/british-columbia/vernon-b- c-schools-to-pilot-program-thatidentifies-addiction-personality-traits-1.3942792

  BACKGROUND

• UNESCO, UNODC, & WHO. (2017). Education sector responses to the use of alcohol, tobacco and drugs. In the UNESCO series Good Policy and Practice in Health Education. Retrieved from http://www.who.int/substance_abuse/activities/education_sector/en/

  BACKGROUND

• Substance Abuse and Mental Health Services Administration (US); Office of the Surgeon General (US). Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health [Internet]. Washington (DC): US Department of Health and Human Services; 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK424857/

  PMID: 28252892 BACKGROUND

• Conrod PJ, Stewart SH, Comeau N, Maclean AM. Efficacy of cognitive-behavioral interventions targeting personality risk factors for youth alcohol misuse. J Clin Child Adolesc Psychol. 2006 Dec;35(4):550-63. doi: 10.1207/s15374424jccp3504_6.

  PMID: 17007600 BACKGROUND

• Woicik PA, Stewart SH, Pihl RO, Conrod PJ. The Substance Use Risk Profile Scale: a scale measuring traits linked to reinforcement-specific substance use profiles. Addict Behav. 2009 Dec;34(12):1042-55. doi: 10.1016/j.addbeh.2009.07.001. Epub 2009 Jul 8.

  PMID: 19683400 BACKGROUND

• Castellanos-Ryan, N., & Conrod, P. J. (2012). Personality and substance misuse: Evidence for a four-factor model of vulnerability. In Verster, J. C., Brady, K., Galanter, M., & Conrod, P. J. (Eds.), Drug abuse and addiction in medical illness: Causes, consequences and treatment (pp. 47-62). New York: Springer.

  BACKGROUND

• Stewart, S. H., Grant, V. V., Mackie, C. J., & Conrod, P. J. (2016). Comorbidity of anxiety and depression with substance use disorders. In K. Sher (Ed.), The Oxford Handbook of Substance Use Disorders. New York: Oxford University Press.

  BACKGROUND

• Conrod PJ, Pihl RO, Stewart SH, Dongier M. Validation of a system of classifying female substance abusers on the basis of personality and motivational risk factors for substance abuse. Psychol Addict Behav. 2000 Sep;14(3):243-56. doi: 10.1037//0893-164x.14.3.243.

  PMID: 10998950 BACKGROUND

• Conrod PJ, Castellanos N, Mackie C. Personality-targeted interventions delay the growth of adolescent drinking and binge drinking. J Child Psychol Psychiatry. 2008 Feb;49(2):181-90. doi: 10.1111/j.1469-7610.2007.01826.x.

  PMID: 18211277 BACKGROUND

• Conrod PJ, Castellanos-Ryan N, Strang J. Brief, personality-targeted coping skills interventions and survival as a non-drug user over a 2-year period during adolescence. Arch Gen Psychiatry. 2010 Jan;67(1):85-93. doi: 10.1001/archgenpsychiatry.2009.173.

  PMID: 20048226 BACKGROUND

• O'Leary-Barrett M, Mackie CJ, Castellanos-Ryan N, Al-Khudhairy N, Conrod PJ. Personality-targeted interventions delay uptake of drinking and decrease risk of alcohol-related problems when delivered by teachers. J Am Acad Child Adolesc Psychiatry. 2010 Sep;49(9):954-963.e1. doi: 10.1016/j.jaac.2010.04.011. Epub 2010 Jul 31.

  PMID: 20732631 BACKGROUND

• Castellanos, N., & Conrod, P. J. (2006). Brief interventions targeting personality risk factors for adolescent substance misuse reduce depression, panic, and risk-taking behaviors. Journal of Mental Health, 15, 645-658.

  BACKGROUND

• Mahu IT, Doucet C, O'Leary-Barrett M, Conrod PJ. Can cannabis use be prevented by targeting personality risk in schools? Twenty-four-month outcome of the adventure trial on cannabis use: a cluster-randomized controlled trial. Addiction. 2015 Oct;110(10):1625-33. doi: 10.1111/add.12991. Epub 2015 Jul 14.

  PMID: 26011508 BACKGROUND

• MacLean's magazine (January 8, 2018). Canadian universities with the highest (and lowest) graduation rates. Retrieved from https://www.macleans.ca/education/canadian-universities-with-the- highest-and-lowest-graduation-rates/

  BACKGROUND

• Thombs DL, Olds RS, Bondy SJ, Winchell J, Baliunas D, Rehm J. Undergraduate drinking and academic performance: a prospective investigation with objective measures. J Stud Alcohol Drugs. 2009 Sep;70(5):776-85. doi: 10.15288/jsad.2009.70.776.

  PMID: 19737503 BACKGROUND

• Dyson R, Renk K. Freshmen adaptation to university life: depressive symptoms, stress, and coping. J Clin Psychol. 2006 Oct;62(10):1231-44. doi: 10.1002/jclp.20295.

  PMID: 16810671 BACKGROUND

• Olthuis, J. V., Watt, M. C., & Stewart, S. H. (2013). Increasing access to evidence-based interventions: The role of technology. Psynopsis, Summer.

  BACKGROUND

MeSH Terms

Conditions

Impulsive Behavior; Binge Drinking

Condition Hierarchy (Ancestors)

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

Study Officials

• Sherry H Stewart

  Dalhousie University

  STUDY DIRECTOR

• Patricia Conrod

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Kara Thompson

  St. Francis Xavier University

  PRINCIPAL INVESTIGATOR

• Matthew T Keough

  York University

  PRINCIPAL INVESTIGATOR

• Marvin Krank

  University of British Columbia- Okanagan

  PRINCIPAL INVESTIGATOR

• Allyson Hadwin

  University of Victoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fakir Md Yunus

CONTACT

306-514-0055; fakir.yunus@dal.ca

Jennifer E Swansburg

CONTACT

902-494-3793; jennifer.swansburg@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 1. A personality-matched wellness program condition in face-to-face format (i.e., high AS student receives face-to-face AS program; high HOP student receives face-to-face HOP workshop: high SS student receives face-to-face SS workshop; high IMP student receives face-to-face IMP workshop) 2. A personality-matched wellness program condition in distance-delivery format (i.e., high AS student receives distance-delivered AS workshop; etc. as per the face-to-face format). 3. Services-as-usual offered by the respective university

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: May 20, 2022
• Study Start: September 11, 2021
• Primary Completion: February 8, 2024
• Study Completion: July 1, 2024
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)