Site: Lady Davis Institute for Medical Research – Jewish General Hospital

Department: Psychiatry

Primary investigator: Ashley Wazana, MD, MSc

Co-investigator(s): Leslie Atkinson, PhD (Toronto Metropolitan), Alain Brunet, PhD (McGill), Suparna Choudhury (McGill), David Dunkley, PhD (McGill), Alison S Fleming, PhD (Toronto), Celia Greenwood, PhD (McGill), James Kennedy, MD (CAMH), David P Laplante, PhD (LDI), Robert Levitan, Md, MSc (CAMH), John Lydon, PhD (McGill), Stephen Matthews, PhD (Toronto), Roberto Sassi, MD (UBC), Alison Shea, MD, PhD (McMaster), Marla Sokolowski, PhD (Toronto), Eszter Szekely, PhD (McGill)

Funding source: Canadian Institutes of Health Research

INFORMATION AND CONSENT FORM

(Young adult participant – active)

Identifying pathways of emerging mental health functioning in young adults from prenatal adversity, genetic susceptibility, early environment, and middle life stress – Leveraging hypotheses generated by an international birth cohort consortium.

Mental Health in Adulthood: Variation in Neurodevelopment and Resilience (MAVAN-R)

You will receive a copy of this completed document by email

INTRODUCTION

You are invited to participate in a research project. This research aims to understand how exposure to maternal stress during pregnancy, combined with genetics, experiences, and behaviors during childhood and/or adolescence, explains mental health functioning in early adulthood. Our research team invites you to participate in this research project because you have been participating in the MAVAN (Maternal Adversity, Vulnerability, and Neurodevelopment) longitudinal study since birth. In order to make an informed decision, you have the right to know the purpose and procedures of this research project, as well as the potential benefits, risks, harms, and compensations associated with it.

Before agreeing to participate in this research project, please carefully read the information contained in this consent form. We encourage you to ask the research coordinator any questions you feel are necessary to understand the implications of your participation. You can contact her at recrutement.mavan.recruitment@ladydavis.ca . Upon receipt of your message, the research coordinator will schedule an appointment to speak with you by telephone or secure videoconference to address your questions and concerns.

You do not have to participate in this research project if you do not wish to.

If you decide to participate in the research project, you will be asked to complete this consent form.

NATURE AND OBJECTIVES OF THE RESEARCH PROJECT

The objective of the MAVAN longitudinal study was to identify and explore a variety of early experiences (particularly pregnancy and childhood factors) and other factors (genetics, sociodemographics) that help explain the development of positive and negative outcomes during childhood and adolescence.

The objective of the current study, now titled Mental Health in Adulthood: Variability in Neurodevelopment and Resilience (MAVAN-R), is similar. We wish to determine how (and if) experiences (positive and negative) during childhood and/or adolescence, alone or in combination with other factors (biological sex, genetics), explain positive and negative functioning (e.g., well-being, thriving, life satisfaction, interpersonal relationships, mood, anxiety, thoughts) in early adulthood.

To conduct this phase of the study, we will invite approximately 400 young adults from our cohorts in Montreal, Quebec, and Hamilton, Ontario. We would like to collect information from you, your mother, and your partner/close friend. This information allows us to better understand your development and functioning. Your mother and partner/close friend will be asked to complete a series of questionnaires about your mood, feelings, thoughts, and behaviors, similar to the questionnaires we will ask you to complete. However, your participation in this study does not require the participation of your mother and/or partner/close friend. You can participate in the study even if you do not want your mother and/or partner/close friend to complete questionnaires about your mood, feelings, thoughts, and behaviors, or if your mother and/or partner/close friend do not want to participate in the study.

RESEARCH PROJECT PROCEDURES

We want to better understand the protective and risk factors associated with the problems experienced by many young adults. The study will be conducted in two parts. Your participation will consist of: i) completing two online questionnaires (90 minutes per questionnaire); ii) completing a series of online computer-based tasks (40 minutes); iii) participating in an online interview about your mental health (2 to 3 hours); and iv) providing saliva DNA samples.

Questionnaires – You will be asked to complete two questionnaires six months apart, via a secure online platform called REDCap. Each questionnaire can take up to 90 minutes to complete. Some questions may seem very similar. This is intentional, as combining answers on the same topic provides a clearer picture than a single answer. Some questions may also seem strange and not relevant to you. This is perfectly normal. The questions are designed to assess many aspects of young adult life; some may therefore be less relevant to you. We ask that you try to answer all the questions. However, you will have the option to skip any questions you prefer not to answer or cannot answer.

REDCap allows you to exit and return to the questionnaires as often as you like by providing you a personalized link to the questionnaires. As such, you do not need to complete all questionnaires in a single session. If for some reason who are unable to log back into REDCap to complete your questionnaire, contact our research office (recrutement.mavan.recruitment@ladydavis.ca) and we will provide you with an updated link. You will obtain a specific link for each set of questionnaires.

We ask that you complete each set of questionnaires within 30 days from the day you consent.

The first set of questionnaires will include:

  1. The 126-item Adult Self-Report will be used to assess your general internalizing (depression, anxiety) and externalizing (aggression) behavior problems.
  2. The 25-item Strength and Difficulties Questionnaire will be used to assess your general internalizing (emotions) and externalizing (ADHD) behavior problems and prosocial behaviors.
  3. The 12-item Social Media/Video Game Addiction Questionnaire will be used to assess your social media and video gaming addictions.
  4. The 54-item Comprehensive Inventory of Thriving will be used to assess your general level of positive wellbeing.
  5. The 4-item Subjective Happiness Scale will be used to assess your general level of happiness.
  6. The 20-item Positive and Negative Affect Schedule will be used to assess your mood and emotional state.
  7. The 5-item Satisfaction of Life Scale will be used to assess your level of life satisfaction.
  8. The 10-item Meaning in Life Questionnaire will be used to assess the presence of and search for meaning in your life.
  9. The 14-item Mental Health Continuum – Short Form and Flourishing Inventory will be used to assess your positive emotional, psychological, and social wellbeing.
  10. The 86-item Life Events Questionnaire will be used to assess the number of major life events you have experienced during your life.
  11. The 11-item Sex, Gender, and Sexual Orientation questionnaire will be used to assess how you self-identify.
  12. The 30-item Bem Sex Role Inventory will be used to assess your masculinity and femininity levels.
  13. The 9-item Demographic Information Questionnaire will ask about your i) languages, ii) current living satiation, iii) education; iv) work status; v) income; vi) relationship status; and vii) children.)

The second set of questionnaires will include (to be completed 6 months after the completion of the 1sr set of questionnaires – you will receive a reminder email and a new REDCap link):

  1. The 30-item Big Five Inventory 2 – Short Form will be used to assess your personality.
  2. The 12-item Experience in Close Relationship Scale – Short Form will be used to assess your adult attachment style.
  3. The 48-item Attributional Style Questionnaire will be used to assess whether you believe internal or external factors influence your behavior.
  4. The 10-item Ruminative Response Scale will be used to assess your level of reflection and brooding.
  5. The 10-item Emotion Regulation Questionnaire will be used to assess your ability to regulate your emotions.
  6. The 24-item Perfectionism Scale will be used to assess your sense of perfectionism.
  7. The 17-item Adult Resilience Measure will be used to assess your level of self-resilience.

With your consent we will ask your parent and partner/close friend to complete the following questionnaire about your thoughts, emotions, and behaviors.

  1. The 126-item Adult Behavior Checklist will be used to assess your general internalizing (depression, anxiety) and externalizing (aggression) behavior problems.
  2. The 25-item Strength and Difficulties Questionnaire will be used to assess your general internalizing (depression, anxiety) and externalizing (aggression) behavior problems .
  3. The 17-item Adult Resilience Measure will be used to assess your level of self-resilience.
  4. The 54-item Comprehensive Inventory of Thriving will be used to assess your general level of positive wellbeing.
  5. The 4-item Subjective Happiness Scale will be used to assess your general level of happiness.
  6. The 20-item Positive and Negative Affect Schedule will be used to assess your mood and emotional state.
  7. The 5-item Satisfaction of Life Scale will be used to assess your level of life satisfaction.
  8. The 10-item Meaning in Life Questionnaire will be used to assess the presence of and search for meaning in your life.
  9. The 14-item Mental Health Continuum – Short Form and Flourishing Inventory will be used to assess your positive emotional, psychological, and social wellbeing.
  10. The 10-item Emotion Regulation Questionnaire will be used to assess your ability to regulate your emotions.
  11. The 24-item Perfectionism will be used to assess your sense of perfectionism.

Computerized Tasks – You will be asked to complete a series of online computerized tasks using CANTAB Connect software that are designed to measure the following: i) sustained attention; ii) working memory; iii) response inhibition; iv) attention shifting; and v) emotional bias. These tasks will take about 40 minutes to complete. You can complete the tasks on any device (including cell phones) but we strongly recommend using a computer or tablet. You will need a speaker (or headphones), a standard keyboard, and a mouse (or another pointing device). You will be provided with a link that will give you access to the tasks. As the tasks are timed, it is recommended that you complete each task once you begin that particular task. You can take breaks between tasks. You can also complete the tasks over a series of days. However, we ask that you complete all tasks within 7 days of starting the first one. If you are having difficulty in accessing the tasks, a member of our research team will be happy to assist you (recrutement.mavan.recruitment@ladydavis.ca). This can be done via the phone or a Zoom (recommended) conversation. We ask that you complete all tasks. However, you are free to skip any task that you do not wish to complete.

Interviews – The interview will take place using a secure and confidential videoconferencing tool (Zoom), at a time specified by you. During the interview, a research assistant will ask you a series of questions about major life events and traumatic experiences you may have experienced and your feelings and behaviors. The interview is designed to assess problems and situations that many young adults face. Some of these topics might not be relevant to you. Other topics you might find too personal or traumatic. You are not required to answer any question that you feel is too personal or makes you too uncomfortable. The interview will last about two-to-three hours. If necessary, you can take breaks and/or we can divide the interview into shorter segments across multiple days.

Audio recording of interviews – If you agree, the interview will be digitally recorded for scoring purposes and to ensure the accuracy and reliability of the assessment of your behavior. The signature page will allow you to indicate your choice.

Salivary DNA Samples – You will be asked to provide saliva samples using a collection kit (Oragene-Discover – OGR-600) that we will send to you. If you agree to provide us with your DNA saliva samples, we will contact you to update your current mailing address. This is a simple and non-invasive procedure. You will be asked to open the packaging, fill the tube with your saliva, close the cap, return the tube to the packaging. The collection tubes will be identified only with your MAVAN/MAVAN-R ID. We ask that you drop the sample in the mail using the self-addressed and pre-stamped envelope. The envelope will be addressed to our research office at the LDI (Dr Ashley Wazana, Centre for Child Development and Mental Health, Lady Davis Institute – Jewish General Hospital, 4335 Chemin de la Côte-Sainte-Catherine, Montréal, QC H3T 1E4) with the return addressed being the Lady Davis Institute (Lady Davis Institute for Medical Research, Jewish General Hospital, Chemin de la Côte-Sainte-Catherine, Montréal, QC H3T 1E2 Attn – Dr Ashely Wazana).

This non-identified DNA saliva sample will be stored in a locked freezer in the research offices at the LDI of the researcher in charge of this study. This non-identifiable sample will be hand delivered to Genome-Québec in Montreal where your genetic information will be obtained. Your de-identified genetic information will be downloaded directly from Genome Quebec’s password-protected secure server. All unused DNA material will be picked up from Genome Quebec.

You can participate in this study even if you do not wish to provide us with your DNA saliva sample.

PARTICIPATION OF YOUR MOTHER IN THE STUDY

As indicated above, we would like to obtain information about your mental health functioning from your mother. If you agree to permit your mother to participate in the study, we ask that you ask her to contact us at recrutement.mavan.recruitment@ladydavis.ca. Upon receiving your mother’s email, we will send her an information letter detailing the study. If your mother wishes to participate following reading this letter, she will be asked to contact us at recrutement.mavan.recruitment@ladydavis.ca email and we will send her a REDCap link so that she can review and complete her own consent form to obtain access to the questionnaires.

PARTICIPATION OF YOUR PARTNER/CLOSE FRIEND IN THE STUDY

As indicated above, we would like to obtain information about your mental health functioning from your partner/close friend. If you agree to permit your partner/close friend to participate in the study, we ask that you ask them to contact us at recrutement.mavan.recruitment@ladydavis.ca. Upon receiving your partner/close friend’s email, we will send them an information letter detailing the study. If your partner/close friend wishes to participate following reading this letter, they will be asked to contact us using our recrutement.mavan.recruitment@ladydavis.ca email and we will send them a REDCap link so that they can review and complete their own consent form to obtain access to the questionnaires.

RISKS AND INCONVENIENCES OF PARTICIPATING IN THIS RESEARCH PROJECT

Physical Risks

As this research involves questionnaires, computerized tasks, DNA saliva collection, and an interview only, we do not anticipate there will be any physical risks from your participation.

Psychological Risks

It is possible that certain questions asked during the research process (e.g., interviews, questionnaires) may cause you distress or other negative emotions. You are free to refuse to answer any question that might cause you distress or negative emotions.

Resources for help – If during your participation in the research study you become upset or distressed, you can contact our office using our recrutement.mavan.recruitment@ladydavis.ca email and our study coordinator will contact you to assist you or direct you to an appropriate resource for help, if you agree.

You can also contact one of the useful resources listed at the end of this document.

Risks of breach of confidentiality

Information about you will be collected electronically, using internet-based data transfer and storage devices, applications, and tools, such as REDCap, CANTAB Connect, and Zoom. The investigator responsible for this research takes measures to protect your personal data (see the “Confidentiality” section below).

Socioeconomic risks associated with genetic research

One of the risks associated with this research project relates to the disclosure of the results or the disclosure of your participation to third parties. Mere participation in genetic research projects could compromise or diminish your chancesand the chances of your family obtaining insurance (life insurance, disability, mortgage, or health) or certain types ofemployment.

To minimize these risks, the collection tubes you will use to provide us with your DNA saliva samples will only be identified using your MAVAN/MAVAN-R ID number. Furthermore, the pre-stamped self-addressed envelope that will be provided to return your DNA saliva sample to our laboratory with not contain your name or mailing address. Likewise, your personal information will not be associated with your sample sent to Genome-Québec for analysis.

Inconveniences associated with your participation in research

You will have to complete two sets of questionnaires, conduct computerized tasks, and participate in the interview which you may find time consuming. However, all tasks are conducted online and can be completed at your convenience.  Moreover, the second set of questionnaires is completed six months after the first set.

POTENTIAL BENEFITS OF PARTICIPATING IN THIS RESEARCH PROJECT

You will receive a report of your results, if you agree, for participating in this research project. This report is not diagnostic in nature: rather it will indicate your outcome (functioning at, below, or above the mean for each completed task) relative to the general population. Moreover, by participating, you can contribute to a better understanding of how maternal stress during pregnancy and offspring genetics interact together and with other factors occurring during childhood and adolescence to help explain the development of psychopathology and/or wellbeing during young adulthood.

INCIDENTAL FINDINGS

Incidental findings are unexpected new information about you that may arise during the research that is not based on the tasks that you have been asked to complete. While we do not expect to observe any outcome that extends beyond the tasks you have been asked to complete, it is possible that after reflecting on your responses to the various questionnaires, executive functioning tasks, and the interview you may feel, for example, that your current mood and concentration problems are potential signs of being depressed or of an attentional problem. If this arises, we will be available to assist you, if you agree, in obtaining the necessary help with the appropriate healthcare professional of your choice (e.g., family doctor, psychologist, psychiatrist, etc.).

DECLARATION OF CONFLICT OF INTEREST

The researcher responsible for this research has no conflict of interest to declare.

COMPENSATION

As compensation for your time, you will receive an amount of $50 for each set of the online questionnaire

es, $25 for the online computerized tasks, $100 for completing the interview and $25 for providing your saliva samples. Your total compensation can be $250.

If you stop your participation before the end of the research activity (questionnaires, computerized tasks, saliva samples, and interview), you will receive compensation proportional to the task/part completed.

This compensation will be delivered to you by e-transfer from our RBC bank account within four weeks of completing each task (questionnaire 1, computerized tasks, interview, saliva samples questionnaire 2) or from the time of your withdrawal.

CONFIDENTIALITY

The Principal Investigator is responsible for the confidentiality and security of research data.

Limited data collection – During your participation in this research project, the researcher in charge of the project and the research team will collect, in a research file, the information concerning you that is necessary to meet the scientific objectives of the research project. This information includes personal information that identifies you, biological sex, date of birth, ethnic origin, education), audio recordings, the information provided in questionnaires, computerized tasks, and interviews. This file will only contain your MAVAN/MAVAN-R ID number.

Codification and retention of information collected – All data collected (including personal information) will remain confidential within the limits provided by law. You will be identified only by your MAVAN/MAVAN-R ID number. The code key (list) linking your name to your research record will be kept separate from other information collected by the researcher responsible for this research project. The folder containing this list and the other folders containing the other information collected will be protected by passwords and kept separately on a secure server of the Lady Davis Institute for Medical Research at the Jewish General Hospital and will only be accessible by the lead researcher and designated members of the research team.

Paper documents, audiotapes, and collected samples will be stored securely in locked cabinets in an office of the Lady Davis Institute for Medical Research at the Jewish General Hospital occupied by the lead researcher and/or designated members of the research team and will only be accessible by the lead researcher and designated members of the research team.

Legal Duty to Disclose – In some situations, legal requirements may prevent researchers from protecting the confidentiality of information provided by participants (e.g., disclosing abuse and/or neglect of children or seniors to appropriate authorities, or the risk of imminent danger to yourself or to a third party, etc.). This mandatory disclosure is intended to protect the well-being of research participants. You must be informed of this.

Use of technology and the Internet – During your participation in this research project, data (information) about you will be collected electronically, using devices, applications, and data transfer and storage tools over the Internet. All technological tools (devices, applications, digital recorders) and means that will be used to collect, transfer, analyze and store the data of research participants will follow a data security plan established by the lead researcher and designated members of the research team. These individuals are qualified to handle your data securely. Data collected using REDCap (questionnaires) and CANTAB (computerized cognitive tasks) are stored on secure servers at each site. Data are transferred to the secure server at the Lady Davis Institute using a two-stage password protected login procedure resulting in a secure data transfer link. The login procedure is only available to the researcher responsible for the study, the project associate, and the study coordinator. All transferred data are stored using password protected electronic files that are housed on a secure server at the Lady Davis Institute.

While the researcher responsible for the research is committed to protecting your data by taking all possible precautions to avoid a breach of confidentiality related to the use of these technologies, it cannot be guaranteed that these safeguards will be 100% effective. If a breach of confidentiality occurs, you will be immediately informed about the nature of this breach. You will also be provided the chance to talk with the researcher in charge of this study about how this breach might affect your mental wellbeing and, if you agree, be assisted in finding the appropriate mental health professional, if necessary. Moreover, and with your agreement, we will schedule additional follow-up sessions to discuss any unresolved issues this breach of confidentiality might have caused you.

Access to data by the participant – You have the right to consult your research file to verify the information collected and have it rectified if necessary, until the start of the data analysis. If you wish to review your research file, you will need to contact the study coordinator and schedule a time to come to our research office at the Lady Davis Institute. During this visit, you will be able to review your data and listen to your interview (if you had agreed to have the interview audiotaped).

Data storage and destruction – Data will be stored on secure servers using password protected electronic files. All files will only include your MAVAN/MAVAN-R ID. Data files can only be accessed using password protected computers. DNA saliva samples will be stored in a secure freezer in the offices of the research responsible for this study. Research data and samples will be stored for 10 years after the end of the research by the researcher responsible for this research project, after which it will be permanently destroyed in a secure manner and in accordance with the guidelines of the CIUSSS du Centre-Ouest-de-l’île-de-Montréal.

Information shared outside Quebec – The researcher responsible for this research project or a member of the research team may send the coded data concerning you to researchers working outside of Quebec. Sharing of non-identifiable data will only occur after a data sharing agreement has been reached between the researcher responsible for this study and the researchers requesting the data.

However, researchers outside Quebec are required to respect confidentiality rules equivalent to those in force in Quebec and Canada, regardless of the country.

Oversight of ethical aspects of the research project – For monitoring, control, protection and security purposes, your research file may be examined by regulatory bodies, in Canada, such as authorized representatives of the Lady Davis Institute for Medical Research or the CIUSSS du Centre-Ouest-de-l’Île-de-Montréal research ethics committee. These people and organizations will have access to your personal data, but they adhere to a privacy policy.

VOLUNTARY PARTICIPATION AND RIGHT TO WITHDRAW

Your participation in this research project is voluntary and ongoing. You are free to refuse to answer any questionnaire items or interview questions or participate entirely in this study without consequences. You can withdraw from this research project at any time, without having to give reasons, by informing the researcher in charge of this research or a research team member.

If you withdraw from the research project, no further data will be collected. The data (and if relevant, the audio recordings) already collected as part of this research will nevertheless be kept, analyzed, or used to ensure the integrity of the research project, as specified in this information and consent form, unless you ask us to destroy them before the analysis of the research data begins. To do so, you will need to send a written request by email to the lead researcher or the research coordinator. We will be able to destroy your data before it is combined with the data of other participants. Otherwise, it will not be possible to remove your data from the study results.

FUTURE USE OF DATA, COMMUNICATION AND PUBLICATION OF RESEARCH RESULTS

Future use of data:

If you allow it, the data collected from you could be used for future research projects related to this research or for other future research, with appropriate ethics review and approval.

Communication and publication of research results:

The MAVAN-R research protocol and study findings will be posted on OpenScience (https://osf.io/).

This research will present its results in an aggregated form (the results of all research participants are combined), and no identifying information about individual participants will be included in reports, publications, or other research communications.

Some quotes from research participants may be included. Although these quotes do not directly identify you, their content may contain unique details about you that would allow people who know you to identify you. In such a case, these elements would be modified to protect your identity.

You can receive a summary of the search results by mentioning your choice at the end of this form. It will be sent to you by a member of the research team as soon as the results are available.

POSSIBILITY OF COMMERCIALIZATION OF RESEARCH RESULTS

Research results resulting from your participation in this research project may lead to the creation of commercial products. However, you will not be entitled to any financial benefit from it.

SHOULD YOU SUFFER HARM

By agreeing to participate in this research project, you do not waive any of your rights and you do not release the lead researcher and the establishment from their civil and professional liability.

If you should suffer any harm whatsoever as a result of any activity related to this research project, you will receive all necessary medical care or social services.

CONTACT INFORMATION

If you have any questions or experience problems in connection with this research project, or if you wish to withdraw from it, you can contact the lead researcher: Ashley Wazana, MD, at (514) 340-8222, ex 27652. Email: Ashley.wazana@mcgill.ca.

For any questions regarding your rights as a participant in this research project or if you have any complaints or comments to make, you can contact:

The local quality and complaints commissioner of the CIUSSS du Centre-Ouest-de-l’Île-de-Montréal at (514) 340-8222 ext. 24222.

DECLARATION OF ETHICS APPROVAL

The psychosocial research ethics committee (PSY) of the CER of the CIUSSS du Centre-Ouest-de-l’Île-de-Montréal has given its ethical approval to the research project and will ensure its follow-up.