What is the purpose of Project BASE?
The goal of the Project BASE is to identify characteristics associated with early sensory issues that may help improve early identification, intervention, and prevention of behavior problems.
Why should I take part in Project BASE?
By participating in Project BASE, you will be helping to advance understanding of how early sensory and pain experiences relate to later behavior and learning outcomes. This will lead to better ways of identifying and treating kids at risk of behavior problems.
Why was my child invited to participate in Project BASE?
Project BASE is recruiting a variety of children who have been seen at the Mayo Clinic for developmental concerns.
Can I stop taking part in Project BASE?
Yes. You can choose to stop participating at any time. Stopping the study will not affect your relationship with your doctors or any part of your child’s medical care.
Will Project BASE share my child’s results with me?
No. The information collected during this project is for research purposes only. It does not inform your child’s medical or educational care.
How will Project BASE share its findings?
Data collected from the project will be shared in research publications and conference presentations. No individual identifying information will be shared.
Who pays for Project BASE?
Project BASE is funded by a grant from the National Institutes of Child Health and Human Development.
Does it cost money to participate?
No. All information and samples collected will be paid for by the research grant. Neither or your health insurance provider will be responsible for paying the costs of the research-related procedures.
Do I get anything for participating?
There is no payment for participating in the study. If you choose to take part in the remote (teleconference) home visits, you will receive a small set of toys to use during our visits that you can keep as a token of our appreciation.
Who do I talk to if I want to participate?
Contact Donna Lawson by phone (504-255-3437) or email (Lawson.Donna3@mayo.edu).
How is Project BASE protecting my data?
All research data that could identify you or your child is replaced with a study ID number. This number allows researchers at the Mayo Clinic and the University of Minnesota to share data about you without sharing anything that could identify you. All your research data and records are stored electronically in a secure, encrypted, password-protected database. We will not release research data about you or your child to others, unless required by law. We will never publish anything about the study on any forum that could identify you without your express permission.
Is identifying information like names, phone numbers, or email addresses shared with anyone outside the research study?
No. No identifying information will be shared with anyone outside the project.
Will the data I provide go into my medical record?
Any information collected only for research purposes will not be included in your child’s medical record.
What happens if I decide to participate?
Every family’s participation will look a little different. You can choose which parts of the study that you wish to complete. Every part is optional. However, we get the most useful information from families who complete all options.
What happens if I choose to participate in…
Saliva collection
A sample of your child’s saliva will be collected by a member of the research staff using a small sponge to swab the inside of his/her mouth. We will look for markers of stress and inflammation in the saliva sample. We will not conduct any genetic testing.
Blood collection
If your child is scheduled to have blood drawn as part of their medical care, the technician will draw a small additional amount for research purposes. We will not conduct any genetic testing.
Skin biopsy
If your child is scheduled for a sedated procedure, a medical professional would take a small (3mm) sample of the top layer of the skin from your child’s calf. We will count the number and types of nerves in your child’s skin.
Sensory test
We will examine your child’s facial and motor reactions to different types of touches on the skin, such as light touch, warm, and sharp. This helps us understand how different children process sensory information.
Parent-child observation
We will connect to you using the internet and a webcam to observe parent and child interactions during play. We will provide access to equipment as needed. If you choose to participate, we will ask you to complete two 30-minute visits per year. We will send out a small box of toys and books before each visit so that you and your child have something new to play with. You can keep the toys after the visit.