5 to 11 Year Olds With Autism Spectrum Disorders Needed for Social Skills Research Study
What is the purpose of this study?
The purpose of this study is to determine the safety and effectiveness of an investigational drug called D-Cycloserine for improving social impairment in children with Autism Spectrum Disorders (ASD) when combined with 10 weeks of social skills group therapy.
Who can participate?
Children 5 to 11 years old who:
• Have autism, Asperger’s disorder or other pervasive developmental disorders (PDD-NOS)
• Have significant social impairment
• Are able to communicate verbally
What is involved?
Your child will be in the research study for about 12 weeks with an additional 3 month follow-up visit. After the initial screening visit, there will be a total of 13 study visits (1 baseline visit, 10 social skills training group sessions, 1 post-treatment visit and 1 follow-up visit).
During the study, your child will be randomly chosen to receive either the study drug, D-Cycloserine, or a placebo. A placebo is an inactive substance that looks identical to the study drug. Neither you, nor the study investigators will know which one your child was assigned.
A detailed list of procedures will be provided to anyone interested in knowing more about this study.
What are the benefits?
Your child may or may not receive any direct benefit from participation in this study. Potential benefits may include the direct benefits that social skills training may have on your child’s symptoms of autism. The information learned from this study may also benefit patients with pervasive developmental disorders and their families in the future.
Will I get all the facts about the study?
If interested in participating, you will be given a consent form that explains all of the details of the study. The form covers all of the procedures, risks, benefits, 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.
Do participants receive pay, compensation or reimbursement?
Participants may receive up to $280 for completing all of the study visits (or $20 per visit).
Who should I contact for more information?
Robert Bermingham
robert.bermingham@cchmc.org
513-803-3602
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue
Cincinnati, OH 45229-3039
Principal Investigator
Craig Erickson, MD
Division of Child Psychiatry
Cincinnati Children’s Hospital Medical Center
