Recruiting

Observational Study

Sponsor:

Sherry Stewart

Code:

NCT05383989

Conditions

Anxiety Sensitivity

Hopelessness

Sensation Seeking

Impulsivity

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

UniVenture Hopelessness manual

UniVenture Anxiety Sensitivity manual

UniVenture Sensation Seeking manual

UniVenture Impulsivity manual

Service as usual provided by the University

Study Details

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

Study ID

NCT05383989

Start date

Sep 11, 2021

Status verified date

May, 2022

Completion date

Jul 1, 2024

Anticipated

Primary completion date

Feb 8, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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)

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

placebo comparator: UniVenture- service as usual (control)

Services-as-usual offered by the respective university

Interventions

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).

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).

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)

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).

Service as usual provided by the University

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

Primary outcome measure

  • Changes in alcohol-related harms in undergraduates [ Time Frame: Past 3 months ]
  • Changes in cannabis-related harms in undergraduates [ Time Frame: Past 3 months ]
  • Changes in the student wellbeing in undergraduates [ Time Frame: Past 3 months ]

Central Contacts and Locations

Central contacts

Locations

University of British Columbia-Okanagan campus

Recruiting

Kelowna, British Columbia, Canada

Contacts

Cassidy RD Wallis, MA

cassidywallis13@gmail.com

Katherine Rose, MA

katherine.rose@ubc.ca

St. Francis Xavier University

Recruiting

Antigonish, Nova Scotia, Canada

Contacts

Stephanie Cooper

scooper@stfx.ca

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada

Contacts

York University

Recruiting

Toronto, Ontario, Canada

Contacts

Matthew Keough, PhD

keoughmt@yorku.ca

Université de Montréal

Recruiting

Montréal, Quebec, Canada

Contacts

Patricia Conrod, PhD

Patricia.conrod@umontreal.ca

More Information

Sponsor

Sherry Stewart

Last update posted

May 27, 2022

Last verified

May, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sherry Stewart on 2022-05-27.