Clinical Trials

A Research Study for Preschool Children With Self-Control Difficulties

What is the purpose of this study?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to develop and test an intervention that teaches self-control, memory and the ability to concentrate and focus to preschoolers and their parents.

Who can participate?

Preschool children 3 and 4 years old who have self-control difficulties may be eligible to participate. 

What is involved?

You and your child will be in the research study for approximately one year. The study includes:

  • An initial visit
  • Participation in the 8-week intervention (1 to 2 hours per week for 8 weeks)
  • A visit at the end of the intervention
  • Two follow-up visits

You and your child will be randomly assigned to receive either the executive function intervention or the child development intervention. A detailed list of study procedures will be provided to parents or guardians interested in knowing more about this study.  

What are the benefits?

You and your child may receive a direct medical benefit from participating in this study.  All participants will receive an evaluation at no charge, as well as a summary report. Also, the information learned from this research study could lead to better prevention and intervention for preschoolers with ADHD symptoms in the future.

If any potential concerns are discovered about your child during the evaluation, such as a psychological disorder, the study doctor will talk with you and make a referral for further assessment.  

Will I get all the facts about the study?

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study.  The form covers all of the procedures, the risks, the benefits, the pay, whom to contact with questions or concerns and more.  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 risks and discomforts of the study?

There is a chance that your child’s condition will continue or become worse during the study, since the interventions are newly developed. Some of the questions we will ask you and the tasks your child may be asked to perform may make you or your child feel uncomfortable, frustrated or bored. Other possible risks or discomforts will be discussed with parents or guardians interested in learning more about this study.

Do participants receive pay, compensation or reimbursement?

Families will receive up to $100 for their time.

Who should I contact for more information?

Study Coordinator

preschoolstudy@cchmc.org

513-803-1345

Behavioral Medicine and Clinical Psychology

Cincinnati Children’s Hospital Medical Center, MLC 10006

3333 Burnet Ave.

Cincinnati, OH  45229-3039

Principal Investigator

Leanne Tamm, PhD

Behavioral Medicine and Clinical Psychology

Cincinnati Children’s Hospital Medical Center