Healthy Preschool Children 3 to 5 Years Old Needed for a Research Study

Monday, September 19, 2016

If interested in learning more about this study, contact Christi Banks at christi.banks@cchmc.org or 513-803-3104. 

research children's cincinnati reading

 

 

Healthy Preschool Children 3 to 5 Years Old Needed for a Research Study

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to look at how a young child’s brain processes stories presented in a traditional (audio or book pages) format compared to an animated format.

We are also looking at the effect of reading and screen time practices at home during early childhood on brain structure and function.

Who can participate?

Healthy, preschool children, 3 to 5 years old, may be eligible for participation.

Children who meet any of the conditions below will NOT be able to participate:

  • Have a non-removable metal implant or device (like a cochlear implant or pacemaker)
  • Were born prematurely (before 38 weeks gestation)
  • Have a history of developmental delay, head trauma with loss of consciousness or stimulant use (such as for ADHD)
  • Speak more than one language or live in a non-English speaking household 

Conditions

  • Healthy Babies Children and Teens

What will happen in the study?

If your child is eligible, and you decide to participate, he or she will come to Cincinnati Children’s for 1 study visit. The visit will last about 2-and-a-half hours.

During this visit, the following tests and procedures will happen:

  • Safety questionnaire: questions telling us if you and your child have any metals or devices on your bodies which will make it unsafe to enter the scanner area
  • Play-based activities: activities that will help your child become familiar with the MRI machine and what he or she will be asked to do when in the scanner
  • Magnetic Resonance Imaging (MRI): a non-invasive test that provides a picture of what your child’s brain looks like
  • Functional Magnetic Resonance Imaging (fMRI): a non-invasive test that takes pictures of the brain and measures brain activity
  • Standardized cognitive-behavioral testing: tests used to measure your child’s vocabulary, behavioral and social-emotional health
  • Parent survey: questions about the types of screen media used (e.g. TV, apps) in your home, the frequency of use, co-viewing, etc.

Before your child enters the MRI scanner room, you will be asked to complete a safety questionnaire on you and your child.

Your child will then be asked to take part in play-based activities (lasting less than 30 minutes) to help him or her be more comfortable with the MRI scanner. After completing the activities, we will ask your child to take the MRI and fMRI scans.

First, a cylinder-like head coil will be placed around your child’s head to help detect important signals from inside the brain. Then, your child will lie on a table that moves him or her into a large tube, which contains a strong magnetic field.

Your child will have the MRI scan first, which will begin with the collection of several standard scans (about 18 to 20 minutes). During this time your child will need to lie still in the scanner and may watch a movie. After the MRI, there will be an fMRI (about 16 minutes), during which your child will hear and/or see a series of simple, fun stories.

After both scans, study staff will administer standardized cognitive-behavioral testing to your child.

While your child is completing the MRI, or when they are completing the standardized testing, you will be asked to complete the parent survey.

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

Your child may not receive any direct benefit from being in this research study right now. When we finish the study, we hope to know more about a reading model developed to account for screen-based format (e.g. tablets) and early reading compared to screen time experiences at home. We also hope that this will help us improve pediatric recommendations and early interventions that may help other children be successful in reading and be as healthy as possible. 

What are the bad things that can happen from this research?

This is a minimal risk study as there are no known long-term effects of MRI procedures on the body. However, your child may feel some discomfort in the MRI machine or there may be a risk we do not know about yet.

A detailed list of possible side effects will be provided to those participants, parents or guardians interested in knowing more about this study. 

Will you/your child be paid to be in this research study?

Participants will receive $50 for their time, effort and travel.