INFORMATION SHEET FOR PARTICIPANTS

REC Reference Number: PNM/08/09-206 YOU WILL BE GIVEN A COPY OF THIS INFORMATION SHEET

Childrens Experiences and Development Study

We would like to invite you to participate in this original research project. You should only participate if you want to; choosing not to take part will not disadvantage you in any way. Before you decide whether you want to take part, it is important for you to understand why the research is being done and what your participation will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Research Aims We are interested in how childrens early experiences in the family and current experiences with family members and peers influence their physical and social development in the early school years. We are specifically interested in identifying factors that explain why some children find it easier than others to deal with stressful situations, such as those children might typically encounter with peers, siblings, or parents. We hope that the project will provide new information on how to best help children succeed in the early school years. At the conclusion of the study, we will provide you with a newsletter summarising the main findings. Who Have We Asked to Participate? We have invited parents and children from across England to take part in the project. All families participated in the Children, Families, and Services in the Community study when their children were three years old. We have invited these families because they have already provided us with some information about their childrens early development. We have invited families that represented a wide range of parenting styles when their children were three years old. Who Must We Exclude? Unfortunately, we must ask you to not participate if your child has a chronic medical condition or significant learning disabilities. If you child has had recent bleeding injuries to the mouth or gums or has a temperature greater than 38C on the day of the visit then we will re-schedule the visit. This is because we will ask your child to give us saliva samples that we will later analyse for a hormone called cortisol. Chronic illnesses and high fever can make cortisol levels artificially high. When blood is mixed with the saliva, it is difficult to get accurate readings of cortisol levels. We will ask your child not to participate if she or he has significant learning disabilities because our questionnaires are not designed for children who might need a lot of extra help understanding what we are asking. When and Where Will the Study Take Place? The study will take place in your home at a time that is convenient to you after school, although we can interview you before your child returns home from school if that is convenient. How Long Will the Study Last? A research worker will visit you and your family for approximately four hours. What Will Your Child Be Asked to Do?

Your child will be asked to answer some questions about his or her behaviour, how he or she copes with difficult situations, how he or she interprets others behaviour, his or her recent experiences of positive and negative life events, and his or her relationship with parents. Your child will also be asked to participate in a competitive computer game against an on-line opponent. We will videotape your child while he or she plays this game. We will provide a laptop computer for the game as well as internet access. Your child will be asked to spit into plastic tubes at 7 time points during our visit and at 3 time points on each of two days following our visit. Your childs saliva will later be analysed for the presence of a hormone called cortisol. We are interested in cortisol because it is produced when people encounter unfamiliar, challenging, and/or distressing situations and these types of experiences will be common to your child in the early school years. Your child will be asked to rub cotton buds on the insides of his or her cheeks. We can get information about your childs DNA from these cheek swabs. Your childs DNA will be used to help us better understand the biological basis of his or her behaviour. We will not give you information about your childs DNA. Your child will be asked to wear a blood pressure cuff around his or her arm that will measure blood pressure and heart rate. We are interested in these things, because they tell us more about how your childs body responds to unfamiliar, challenging, and/or distressing situations. The blood pressure cuff will not be painful in any way. Your child will be asked to wear an activity monitor around his or her wrist while she or he sleeps for two nights following the home visit. The activity monitor looks like a wristwatch, is very light in weight, and records how active your child is. We will ask your child to wear the activity monitor because we need to know exactly when your child woke up on each of the two days following our visit.

What Will You Be Asked to Do? You will be asked to answer questions about your childs behaviour, his or her recent experiences of positive and negative life events, your childs relationship with you, your own (and, if relevant, your partners) psychological well-being, behaviour, and substance use, and about your family situation more generally (e.g., questions about your own and, if relevant, your partners education, employment status, family income, how many children and adults live in your house, etc.) We will also ask you to use cheek swabs to provide us with your DNA so that we can better understand the biological basis of your behaviour. We will not give you information about your DNA. For two days following our visit, we will ask you to help us collect saliva samples from your child as soon as your child wakes up, 30 minutes after your child wakes up, and immediately before your child goes to sleep. We will give you extensive instructions on how to do this when we visit you. At the end of the two days, we will arrange to collect the samples from you at a time that is convenient for you. We will ask your permission to contact your childs teacher for information about your childs behaviour at school. We would like to ask your childs teacher the same questions about your childs behaviour

that you and your child answered. By collecting information on your childs behaviour from many different perspectives, we can gain a more complete picture of your child. Why Are We Collecting DNA? Most of the DNA contained in our genes and chromosomes is identical in all people, but at specific sites in our DNA, people carry different forms, also called variants. These differences are usually completely harmless. For example, they may influence whether you have straight hair or curly hair. However, some DNA variants are associated with our behaviour, for example, whether we tend to be shy or outgoing. Genetic research studies try to identify these variants and test whether they are associated with behaviour or abilities. In this study, DNA will be extracted from the sample you (and your child) give, and your own DNA and your childs DNA will be genotyped in a laboratory to determine which form of the variants you carry at specific DNA sites. These analyses will tell us, for example, whether children who are hyperactive have a different form of DNA than children who are not hyperactive. Will You Compensate Me for My Time? Yes. To thank you for taking the time to participate, we will offer you a 20 gift voucher at the conclusion of the home visit and we will offer your child a 10 gift voucher. If you return the saliva samples to us once you have collected them from your child over the two days following our visit, we will send you a 15 gift voucher. If you give us permission to contact your childs teacher, we will also send him or her a 10 gift voucher along with the questionnaire about your childs behaviour, as a way of compensating teachers for their time. You will not, however, benefit financially from the research in any other respect. Are There Any Risks Involved in Participating? The risks involved in participating are minimal. The computer game we will ask your child to play is mildly distressing for some children, but we will stop the game in the unlikely event that your child becomes extremely distressed. If there are questions that you find distressing or intrusive, you are free to not answer those questions or to withdraw from participating. We will make sure your child understands that if there are questions he or she finds distressing or intrusive, then she or he need not answer them. We will make sure your child understands that she or he can withdraw from participation at any time without penalty. Are There Any Benefits Involved in Participating? At the conclusion of the project, we will send you a newsletter describing the major findings and alerting you to any research publications we have generated from the project. How Will We Maintain Your Privacy and Confidentiality? Everything you and your child tell us will remain completely confidential within the limits of the law. We will give you an identification number to replace any information we have in the data file that identifies your name, your childs name, and your address or any other contact details we have for you. The information that you and your child give us during the interview will be completely anonymised and linked only to the numerical ID. The information you give us during the interview will be completely anonymised and the only thing to identify your questionnaires and biological samples will be a numerical ID.

Your information including your own and your child responses to questionnaires, information about your own and your childs DNA, and information about your childs cortisol levels will be stored on secure computers in locked offices and in locked file cabinets. At the conclusion of the study, these data may be made available in totally anonymous form to other researchers outside of the Project team. This means that, with your permission, researchers outside our Project team will have access to the answers you and your child provided on our questionnaires, information about your childs cortisol levels, and information about what forms of DNA you and your child have. However, they will have no means of identifying you. Your childs saliva samples and your own and your childs genetic material (DNA) will be stored in locked freezers for future analyses in conjunction with the planned project. These materials will only be available to members of the Project team. Please see the attached sheet for answers to frequently asked questions about DNA and why we are collecting it. Please note that there is a difference between biological materials and biological data. Biological materials include the cheek swabs that we will ask you and your child to provide and the saliva samples that we will ask your child to provide. These will not be made available to researchers outside the Project team. Biological data include the information we get from your biological materials after we have analysed it. For instance, after we analyse your childs saliva samples, we will have information about his or her cortisol levels at various points during our visit. These numbers will be made available to researchers outside our Project team in totally anonymous format. There is no way that other researchers will be able to link the information to you. The videotapes we make of your child during the computer game will be stored in locked cabinets and will be made available only to members of the Project team. They will not be made available to researchers outside of the team. Your responses to our questions will remain completely confidential unless you tell us something to indicate that your own health and safety or your childs health and safety are currently in danger. Who is Organising and Funding the Research? The Childrens Experiences and Development Study is being organised by a team of researchers at Kings College London. The Principle Investigator is Dr. Miriam Watts, of Kings College London. The study is being funded by the Nuffield Foundation and the Economic and Social Research Council. What If I Have Questions about the Project? Please contact Miriam by email at email address, by phone at telephone number, or by post at Institute of Psychiatry, 16 De Crespigny Park, London, SE5 8AF.

It is up to you to decide whether to take part or not. If you decide to take part you are still free to withdraw at any time and without giving a reason. You may withdraw your data or your childs data from the project at any time up until the DNA is genotyped (1 January 2011). If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you agree to take part, you will be asked whether you are happy to be contacted about participation in future studies. Your participation in this study will not be affected should you choose not to be recontacted. If this study has harmed you in any way you can contact King's College London using the details below for further advice and information: Dr Miriam Watts Email address and telephone number