Study information for children

For the parent: This information can be used to tell your child more about the research study. It is important that even young children have an opportunity to express their views and participate in research on their terms.

We believe that you know your child best and are best placed to tell your child about the research. However, we have experience of telling children about research and can help you with this. If you would like more information or help with this, please contact at l.brewer2@newcastle.ac.uk me to discuss this.

Thank you again for your interest.

Lelanie

Hello, I’m Lelanie

I want to know more about how you do self-care like eating, getting dressed and cleaning yourself?

Information for parents and carers on the EASIER Study

You are invited to take part in a research project: Early Self-Care Development in Young Children

What is the purpose of this project?

To find out children’s independence at carrying out daily activities develop.

Who are we looking for to participate?

We are looking for typically developing children, and children with difficulties with movement or with concerns about physical development. We are looking for a wide range of children and families to participate. We are inviting you to take part if your child is 33 -36 months old. Study participants living in England are eligible to participate.

What will happen to me and my child as part of the research?

We will ask you to provide:

  1. BASIC information about your family and child. This would require you to complete a short questionnaire (approximately 5-10 minutes to complete) online.
  2. DATA ABOUT YOUR CHILD’S SELF-CARE ACTIVITY and YOUR FAMILY LIFE. This would require you to complete a questionnaire on your child’s self-care development every six months.

Your answers to the questionnaires will be confidential and will not be shared with your therapy providers.

Will me or my child be tested for an intervention?

No. This study will not test any interventions. This study seeks to understand children’s early self-care in order to develop better interventions.

Can I refuse my and my child’s participation?

Yes, absolutely. You are free to say either yes or no. Your decision will not affect you or your child in any way, and we will not contact you any further if you decide not to participate.

What are the possible risks and burdens?

We do not think that this study will have risks to you or your child. The study does not involve intrusive treatments or interventions. The study does not involve denying any treatment or advice from you or your child. The data collection does not address sensitive topics.

The research will need you to give your time to complete online questionnaires. Taking part in this research will take approximately 15 minutes every 6 months. You will be contacted 7 times over 3 years.

What are the possible benefits?

You will help NHS services to understand how children with movement concerns develop. This will enable better treatments and better ways to support families.

Young children, especially children with developmental problems, do not often get to take part in research. This means treatments for them do not develop as fast as treatments for other children and adults. It is important that children with developmental concerns are involved in research, and that treatments for them can be improved.

As part of the research you and your child will receive small rewards which will include tips and ideas to help your child’s development, and will have early access to the study results.

What information will be held about me, my child and my family?

At the moment, we do not hold any information about you and your child. If you decide to take part, we will hold the information collected from you and your child.

Who will receive the information collected, and what will happen to the information?

Lelanie Brewer, PhD student at Newcastle University and lead researcher for the project, will receive the information. The information will be held securely in Newcastle University for 10 years. Lelanie is a researcher and and a HCPC registered children’s Occupational Therapist. She is bound by a professional code of conduct and and the University’s rules on confidentiality. Lelanie is responsible for ensuring that your data is handled appropriately and kept confidential.

Will the information be confidential?

Your personal details will be kept strictly confidential. Your personal details will be recorded and stored separately to the the information you give when completing the questionnaires.

Recorded assessment data will only be seen by the research team and will be anonymised during analysis. Researchers will be bound by confidentiality agreements and your questionnaire data will be fully anonymised during analysis. Following the study, the data you provide will be securely stored by Newcastle University for 10 years. If information is collected during the research that gives concerns for participants’ safety, this information will be shared with appropriate people to keep participants safe.

GDPR

Newcastle University will be using information from you, your child and your therapist in order to undertake this research study and will act as the data controller for this study. This means that Newcastle University is responsible for looking after your information and using it properly. When we use personally-identifiable information from people who have agreed to take part in research, we ensure that it is in the public interest. Your rights to access, change or move your information are limited, as Newcastle University needs to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, Newcastle University will keep the information about you that has already been obtained. To safeguard your rights, the minimum personally-identifiable information will be used. You can find out more about how Newcastle University uses your information at http://www.ncl.ac.uk/data.protection/PrivacyNotice and/or by contacting Newcastle University’s Data Protection Officer (Maureen Wilkinson, rec-man@ncl.ac.uk).

We will use your name and the contact details you provide us with (telephone number, address, email) to contact you about the research study. Individuals at Newcastle University may look at your research data to check the accuracy of the research study. The only individuals at Newcastle University who will have access to information that identifies you will be individuals who need to contact you to arrange interviews, observations and meetings or audit the data collection process.
If you agree to take part in the research study, the information provided by you may be shared with researchers running other research studies at Newcastle University and in other organisations. These organisations may be universities or NHS organisations. Your information will only be used by organisations and researchers to conduct research. This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose research, and cannot be used to contact you. It will not be used to make decisions about future services available to you.

How will the study findings be published

We plan to publish the findings to parents and children, policy makers, children’s healthcare providers, and other researchers. In the publications, we will not involve any information that could be used to identify you or your child. We will not make details about you or your child public at any point. If you would like to receive alerts about any publications, please do let us know. We can add you on the study mailing list.

Who is paying for and conducting the research

This study is a self-funded PhD study. It is carried out by the sponsor, Newcastle University in collaboration with a NHS trust in England.

Is there an NHS Research Ethics Committee approval?

The study has approval from East Midlands – Derby Research Ethics Committee.

What if I want more information, or if there is a problem?

If you have a concern about any aspect of this study contact the researchers who will do their best to answer your questions. Lelanie, the lead researcher, can be contacted at l.brewer2@newcastle.ac.uk

If you remain unhappy and wish to complain formally, you can do this by contacting the Newcastle University joint research office quality assurance team on 0191 2825705.

I am interested in taking part – what should I do now?

Share the children’s participant information with your child and talk to them about the study.

Contact Lelanie at l.brewer2@newcastle.ac.uk to let her know you and your child are interested in taking part. She will send you the link for the study questionnaire and answer questions that you might have about taking part in the study.

THANK YOU

More about the researcher

Lelanie Brewer is a children’s Occupational Therapist and PhD candidate at Newcastle University. She is registered with the Health and Care Professions Council in the United Kingdom.

Her research interests include child development and factors influencing children’s participation in daily life. Lelanie is a member of the CHILD research group at Newcastle University and the PhD supervisors for the EASIER study are Dr Niina Kolehmainen and Prof Mark Pearce.

Awards and Grants

The EASIER study has been awarded research funding from the Elizabeth Casson Trust and the Royal College of Occupational Therapy’s Children, Young People and Families subgroup.