CUSP Trial Consent - UBCO

Dear Student,

A team of researchers across Canada are conducting a research project called the CUSP Trial, which will compare the experiences of 4050 or more high school students over three years across Canada. Your school is involved with the project and as part of this study we will be inviting all students in your grade, including you, to take part in the study.

The study is led by Dr Patricia Conrod, a clinical psychologist and professor at Sainte-Justine Hospital and the University of Montreal. Other members of the research team are: Dr Marvin Krank and Dr Chris Richardson from the University of British Columbia, and Mr David Smith from BC Interior Health in British Columbia; Dr Sherry Stewart from Dalhousie University in Nova Scotia; Dr Hayley Hamilton, Dr Jürgen Rehm and Dr Joanna Henderson from the Centre of Addiction and Mental Health in Ontario.

  1. WHAT IS THE NATURE AND THE GOAL OF THE STUDY?

The main purpose of this study is to evaluate the long-term effects of the PREVENTURE program on delaying the on-set of drug and alcohol use in adolescence. PREVENTURE involves delivering specialised coping skills group workshops to students, with only around 45% of students in given grade invited to participate in a workshop. In addition, in order to help us better understand the impact of the Covid-19 pandemic on youth, a few questions regarding their Covid-19 experiences will be asked. You are invited to refrain from answering any questions that may cause you discomfort.

The study has been approved by the Research Ethics Board at Sainte-Justine Hospital. Your school board has also approved and supports the project. The program’s targeted approach to prevention aligns with current school initiatives to prevent drug and alcohol consumption. The program also provides student with coping skills that can help them in other aspects of their academic lives. The project is funded by the Canadian government.

  1. WHAT WILL HAPPEN IN THIS RESEARCH STUDY?

If you agree to participate in the project, you will be invited to complete a 45-60 minute computer-based survey on personality, strengths and weaknesses, different health-related behaviours and learning style. All students that agree the take part will complete the same survey each academic year for the next three years. Some students may also be invited to take part in two brief PREVENTURE program workshop sessions to learn about life skills and reaching their goals.

This study is a cluster randomised trial, which means that of the 27 schools across Canada that are part of the project, 18 schools will be randomly assigned to the INTERVENTION group to receive the PREVENTURE program. The other 9 CONTROL schools will have access to usual drug and alcohol education through the school curriculum as well as mental health care provided through student counseling. After the study is finished PREVENTURE will be offered to the CONTROL schools.

Invitations to the workshops will depend on the answers to the survey questions and will be generated by an autonomous system. The workshop sessions will be run by a staff member at your school and you will get the chance to interact with other young people in your year group.

The workshops are designed to:

  • motivate students to understand how their personality type leads to some emotional and behavioural reactions;

  • enable students to develop skills to better focus their strengths and weaknesses towards their goals;

  • equip students with tools to better manage real consumption situations.

If you agree to take part in the study, you will be invited to voluntarily participate in the survey over the next three years and you may able be invited to participate in a coping skills workshop at some point during the study.

  1. WHAT ARE THE BENEFITS OF PARTICIPATING IN THE PROJECT?

Your input will be of great value in trying to identify the health and wellbeing experiences of young people. A number of studies have shown that students who participate in the PREVENTURE program workshops report reduced drug use, binge drinking and mental health problems over a two-year period, relative to children who do not. Furthermore, benefits of the program have been shown to generalize to students attending schools that deliver the program but do not take part themselves in the workshops. Therefore, you could directly or indirectly benefit from the program once it has been implemented at your school.

  1. WHAT ARE THE RISKS?

There are no demonstrated or anticipated physical risks to being involved in this study or in PREVENTURE workshops. Potential psychological risks are minimal and could involve possible discomfort from responding to questions about one’s emotional state.

  1. IS YOUR PARTICIPATION VOLUNTARY?

Some of the questions asked are personal and participation in every aspect of the project is voluntary. Students can choose to refrain from answering any questions that may cause them discomfort. Your participation in the project is entirely voluntary and you can withdraw from the study at any point, without having to provide reasons. At which point all data provided by you will be immediately destroyed.

  1. HOW IS PRIVACY ENSURED?

All information collected will remain completely confidential as required and permitted by law. All personal information will be protected by replacing names with research codes that will be securely stored under the responsibility of the principal investigator at the Sainte-Justine Hospital for at least 7 years after which it will be destroyed. Only authorized research team members will have access to this information.

In order to ensure your protection and the quality control of the research project, a delegate of the ethics committee of the CHU Sainte-Justine research center could consult your research records.

If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

The findings from the study will not be reported in a way that any individual can be identified. Any personal information we collect will be kept confidential and private. Only in situations where a student indicates that they are at imminent risk of harm to themselves or others will we contact the school. The school will then evaluate and decided whether to discuss this further with the student.

  1. WHO DO I CONTACT IF I HAVE QUESTIONS OR CONCERNS?

If you or your parent has any questions or concerns about the CUSP study you can contact the lead researcher in Montreal, Dr Patricia Conrod:

Centre de Recherche, CHU Ste-Justine

3175 Côte-Ste-Catherine, Montréal, QC, H3T 1C5

patricia.conrod@recherche-ste-justine.qc.ca

514 345 4931 (ext 4051)

You can also contact Dr. Marvin Krank: [ marvin.krank@ubc.ca ]

If you would like information about your rights related to your participation in the research, you may contact the hospital Ombudsman (Patient Representative) at CHU Sainte-Justine (Montreal, Quebec): (514) 345-4749.

If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line in the UBC Office of Research Services at 1-877-822-8598 or the UBC Okanagan Research Services Office at 250-807-8832. It is also possible to contact the Research Participant Complaint Line by email ( RSIL@ors.ubc.ca ). Please reference the study number (H18--03373) when contacting the Complaint Line so the staff can better assist you.

Please see next page for the CONSENT FORM.