The UniVenture Program

May 24, 2022 updated by: Sherry Stewart

UniVenture: A Partnership to Address Heavy Drinking and Other Substance Misuse on Canadian University Campuses

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The UniVenture program is a wellness program designed for university students, to be tested at 5 university-based sites (Dalhousie University, St. Francis Xavier University, York University, Université de Montréal, and University of British Columbia-Okanagan), and based on an existing, successful, and internationally recognized and -utilized program called PreVenture (designed for high school students). PreVenture is a selective personality-targeted approach based on an etiologic model of substance misuse behaviors, outlined and validated by Drs. Stewart (Project Director [PD]) and Conrod (Co-Applicant [CA]). PreVenture targets personality-specific motivational pathways to substance misuse, AS, HOP, SS, and IMP, each associated with different motives for substance use, substance use profiles, and patterns of emotional distress and risk-taking. Well-controlled studies show PreVenture reduces or delays teens' binge drinking, illicit drug use, and associated emotional problems by 30-80% with effects lasting at least 2 years. While PreVenture: (a) was designed for and is effective for high school students, its efficacy in university students is untested; (b) is effective for alcohol and cannabis use, its effects on prescription drug misuse are unknown; and (c) works to reduce student distress, it is untested for preventing academic struggles and university drop out. These latter academic outcomes are of major concern to our Student Affairs partners given the current shockingly high university drop-out rates (18.7-36.9%) and strong ties of student substance misuse and distress with poorer academic outcomes. The purpose of the UniVenture study is to measure the efficacy the developmentally adapted program has on primary outcomes of (1) Reduction of alcohol-related harms in undergraduates (2) Reduction of cannabis-related harms in undergraduates (3) Changes in the student wellbeing in undergraduates. Secondary outcomes are (1) Differences in semester GPA between treatment groups. (2) Changes in scores on the undergraduates' Academic retention measure (3) Changes in scores on the undergraduates' Academic challenges measure (4) Changes in scores on the undergraduate self-regulated learning (SRL) behaviour measure and Self-efficacy beliefs for undergraduates' success measures (5) Reduction in score of hazardous drinkers in undergraduates.

Barriers to accessing evidence-based programs contribute to the ineffectiveness of campus-based substance misuse prevention. These barriers include students' time commitments, lack of available services, fear of stigma, and long wait lists which may discourage students from seeking or engaging in existing programs, leading to more severe problems before participants receive help. A distance-delivery approach involves using remote communication technologies (e.g., web-based, email, chat) to link students with a facilitator in place of face-to-face meetings. This may improve access for those with difficulties getting to services or increase confidentiality through engagement from a private location. The investigator proposes a novel randomized controlled study to test the relative effects of our personality-targeted wellness program on hazardous drinking, cannabis use, and uptake of prescription drug misuse among high-personality-risk 1st and 2nd year undergraduates and delivered in 2 formats: traditional face-to-face vs. an innovative and more accessible technology-assisted distance-delivery by well-trained and supervised program facilitators. These two active program conditions will be compared to a services-as-usual only control condition to evaluate how this program compares to what Student Affairs unit partners already do. Withholding the program from at-risk undergraduates randomized to the services-as-usual only control group might be seen as problematic; however, the program's efficacy is untested at the emerging adulthood (EA) developmental stage and in the university context. If the distance-delivered program is shown effective, control condition participants will be sent a free link to the relevant personality-matched web-based materials after the 12-month follow-up.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
    • Nova Scotia
      • Antigonish, Nova Scotia, Canada
        • Recruiting
        • St. Francis Xavier University
        • Contact:
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Toronto, Ontario, Canada
    • Quebec
      • Montréal, Quebec, Canada
        • Recruiting
        • Université de Montréal
        • Contact:
        • Sub-Investigator:
          • Natalie Castellanos-Ryan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1st 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)

Exclusion Criteria:

• Unwilling to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: UniVenture- face-to-face (in-person format)
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
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).
Behavioral: UniVenture Anxiety Sensitivity manual
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).
Behavioral: UniVenture Sensation Seeking manual
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)
Behavioral: UniVenture Impulsivity manual
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).
ACTIVE_COMPARATOR: UniVenture- online (distance-delivery format)
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
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).
Behavioral: UniVenture Anxiety Sensitivity manual
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).
Behavioral: UniVenture Sensation Seeking manual
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)
Behavioral: UniVenture Impulsivity manual
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).
PLACEBO_COMPARATOR: UniVenture- service as usual (control)
Services-as-usual offered by the respective university
Behavioral: Service as usual provided by the University
It is the regular university-provided well-being services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in alcohol-related harms in undergraduates
Time Frame: Past 3 months

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
Time Frame: Past 3 months

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
Time Frame: Past 3 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in semester GPA between treatment groups.
Time Frame: Through study completion, an average of 1 year

Semester-wise grade point average [GPA] as a proxy of Undergraduates' academic performance (i.e., objective indices of grades). GPA data retrieved from the registrar's office at each site will be converted to a common 6-point GPA scale since different university sites use different GPA scales (%, 5-point GPA, 9-point GPA). The scale ranges from 1 to 6 where 1 indicates lower performance and 6 indicates higher performance.

[Higher scores indicate higher GPA in that semester.]
Through study completion, an average of 1 year
Changes in scores on the undergraduates' Academic retention measure
Time Frame: Through study completion, an average of 1 year

Measured by the 6-item self-reported Academic outcome survey: Academic experience scale. Item response options include (1) Strongly disagree (2) Disagree (3) Neither agree nor disagree (4) Agree (5) Strongly agree. A total score is derived by summing scores across the 6 items.

[Higher scores indicate higher academic retention].
Through study completion, an average of 1 year
Changes in scores on the undergraduates' Academic challenges measure
Time Frame: Past 2 weeks

This is assessed with a 35-item Academic outcome survey. This composite score [Self-Regulated Learning -Challenges Scale (SRL-C)] will represent the academic challenges experienced. Item response options range from: (1) Strongly disagree to (5) Strongly agree.

The composite score is comprised of five areas of academic challenges typically reported by undergraduate students: (1) Motivation (e.g., challenges initiating and sustaining engagement); (2) Goal and time management (e.g., challenges making deadlines, or managing priorities) (3) Cognitive (challenges maintaining focus, understanding course material (4) Socio-emotional (challenges adjusting to new academic expectations; balancing health and well-being); and (5) Meta-cognitive (challenges setting goals or choosing strategies).

[Higher scores on the composite indicate greater levels of academic challenges being experienced by the student.]
Past 2 weeks
Changes in scores on the undergraduate self-regulated learning (SRL) behaviour measure and Self-efficacy beliefs for undergraduates' success measures
Time Frame: Past 2 weeks

Two separate scales [SRL Self-Regulated Learning -Practices Scale (SRL-P) and Self-Regulated Learning -Challenges Scale (SRL-C)] will be combined and consist of 35 items from the Academic outcome survey with response options of (1) Strongly disagree (2) Disagree (3) Neutral (4) Agree (5) Strongly agree.

[Higher scores indicate more proactive self-regulated learning behaviours/practices and indicate stronger belief about academic success]
Past 2 weeks
Changes in score of hazardous drinkers in undergraduates
Time Frame: Past 3 months

This 3-item The Alcohol Use Disorders Identification Test Consumption screening tool (AUDIT-C) questions (composite score) capture individuals who are hazardous drinkers or who have alcohol use disorders (including alcohol abuse or dependence). It is scored on a scale of 0-12 points (each item has maximum of 4 score where 0 reflect no alcohol use). In men, a score of 4 points or more is considered positive for alcohol misuse; in women, a score of 3 points or more is considered positive.

Generally, the higher the AUDIT-C score, the higher the likelihood of affecting health and safety due to individual's drinking.
Past 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherry Stewart

Collaborators

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

Investigators

  • Study Director: Sherry H Stewart, Dalhousie University
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 11, 2021

Primary Completion (ANTICIPATED)

February 8, 2024

Study Completion (ANTICIPATED)

July 1, 2024

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

May 17, 2022

First Posted (ACTUAL)

May 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-5689

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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