CUSP Trial Consent - NS

Dear Student

A team of researchers across Canada are conducxting a research project called the CUSP Trial, which will compare the experiences of 4050 or more high school students per year, over three years across Canada. Your school is involved with the project and as part of this study we will be inviting all year 10 students and year 11 students in 2023-2024, including you, to take part in the study.

Who are the investigators?

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.

What is involved?

The main purpose of this study is to evaluate the long-term effects of the PREVENTURE program on delaying the onset of drug and alcohol use in adolescence. PREVENTURE involves delivering specialised coping skills group workshops to students, with about 45% of students in a given grade invited to participate in a workshop. The program's targeted approach to prevention aligns with current school initiatives to prevent drug and alcohol consumption as well as provides students with coping skills that can help them in other aspects of their academic lives. 

The study has been approved by the Health Sciences Research Ethics Board at Dalhousie University [REB 2019-4769]. The Halifax Regional Centre for Education (HRCE) has given permission for this project to be carried out at your school.

If you agree to participate in the project, you will be invited to complete a 45-60 minute computer-based survey on your personality, strengths and weaknesses, different health-related behaviours and learning style. The survey includes clinical screening tools; however, the results will not be used for the purposes of diagnosis. All students that agree to take part will be invited to complete the same survey each academic year for the next two years. Some students who agree to take part in the study may also be invited to participate 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 who are part of the project in 2023-2024, 18 schools will be randomly assigned to one of two INTERVENTION groups which will 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 grade. 

The workshops are designed to: 

  • motivate adolescents 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 toward their goals;
  • equip them 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 two years and you may able be invited to participate in a coping skills workshop at some point during the study.

What are the benefits?

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 students who do not. Furthermore, benefits of the program have been shown to generalise 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.

 

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.

 

 

Compensation

To acknowledge and recognize contribution to the trial, participants who provide both signed consent and complete the CUSP Trial student survey will be eligible to win a $60 Amazon Gift Card /OR/ choose a similarly valued prize from a prize list. Winners will be chosen through a raffle with a 1 in 25 chance of being chosen. 


Is my 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.

 

How will my privacy be protected?

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.

The findings from the study will not be reported in a way that any individual can be identified. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.

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 decide whether to discuss this further with the student. All students will be provided with a list of youth services at the end of the survey and reminded that staff are available should they need support, information, or someone to talk to.

 

Who may I contact if I have questions?

If you have any questions or concerns about the CUSP study you can contact the lead researcher in Nova Scotia, Dr. Sherry Stewart:

Dr. Sherry Stewart

Professor of Psychiatry, Psychology, and Community Health and Epidemiology Tier 1 Canada Research Chair in Addictions and Mental Health Department of Psychiatry and Psychology, Dalhousie University

Halifax, NS Canada, B3H 4J1

Phone: 902.494.3793

Email: sstewart@dal.ca

Alternatively, you can also contact the lead researcher in Montreal, Dr. Patricia Conrod: 

Dr. Patricia Conrod

Tier 1 Canada Research Chair, Professor of Psychiatry, Université de Montréal. Senior Research Chair in Social and Community Pediatrics, Fondation Julien/Marcelle et Jean Coutu Centre de Recherche, CHU Ste-Justine

Montréal, QC, H3T 1C5

Phone: 514.345.4931 (ext 4051)

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

School Contact Person

Dunovan Kalberlah

Principal, Bay View High School

Phone: 902.826.3222 ext. 790-1096

Email: dkalberlah@hrce.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 would like to learn more about the study and our research team, please click on the attachment below and visit our website: www.cusptrial.ca

CUSPInfographic.pdf

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COMPREHENSION CHECK!

Are there any potential benefits from participating in the study?

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COMPREHENSION CHECK!

Are there any known risks associated with participating in the study?

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COMPREHENSION CHECK!

Do you have the choice to participate (or not participate) in this study?

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COMPREHENSION CHECK!

Who will know what I say or share during my participation in the study?

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