Patient or Parent-Guardian Survey
1. Information Sheet
Information about the Research Study entitled:
“Assessing Medication Responsiveness in Persons with Autism Spectrum Disorders (ASD)”
[IRB#: 091045] The George Washington University
You are invited to participate in a research study under the direction of Dr. Valerie Hu of the Department of Biochemistry and Molecular Biology, The George Washington University Medical Center (GWUMC), and paid for by The George Washington University. Taking part in this research is entirely voluntary.
Introduction: Many different medications are prescribed to individuals with autism spectrum disorders (ASD) without knowing the biological causes of autism. Because many prescriptions are based upon “trial-and-error”, there are people who don’t experience any benefits at all while others experience a substantial improvement. Many parents of children with ASD have referred to this substantial and noticeable improvement as a “Wow!” effect.
The purpose of this study is to find out how persons with ASD respond to certain medications and whether or not these medications help make their symptoms better. We would also like to have your (or your child’s) treating doctor answer a survey on how s/he thinks you (or your child) is responding to these medications. There is no age-limit or age-range specified for subjects enrolled in this study.
Long-range goals: By doing this study, we hope to learn information that may help doctors better prescribe medications to their patients. It may also help us design future research studies.
YOUR ROLE IN THIS STUDY
If you choose to take part in this study, you will be asked to:
1) Complete a survey which asks for information about the medication(s) you (or your child) are taking and your personal opinion as to whether the medication is effective in reducing the symptoms for which the medication was prescribed; You may complete the survey online or print a hard copy (from the PDF attachment in the recruitment email) which may be completed and mailed directly to us at the address given at the end of the survey. We will be happy to compensate you for postage.
2) Request that your (or your child’s) treating doctor complete a brief survey about the medication(s) that you (or your child) are currently taking; You may forward the weblink (www.surveymonkey.com/GWautismstudy-clinician) containing the description of the study and survey to the doctor where s/he may complete the survey online. Alternatively, your doctor may print a hard copy (from the PDF attachment in the recruitment email) and, after filling it out, mail it directly to us at the address given in the survey. [We will ask your (or your child’s) doctor questions about how well the medication is working.]
3) Complete a simple drawing task. If you (or your child) elect to participate in this study, you will be provided with the necessary materials and instructions by mail. The drawings will provide us with information about your (or your child’s) strengths, abilities and current performance level.
The total amount of time you will spend in connection with this study is estimated to be 1 hr to fill out the questionnaire, 20 minutes to complete the drawing task, and the time it takes to request and to obtain a completed questionnaire from your (or your child’s) clinician. You may refuse to answer any of the questions and you may stop your participation in this study at any time.
Possible risks or discomforts you could experience during this study include: possible loss of confidentiality, anxiety over answering questions related to medications or your feelings about their effectiveness, risk of eating non-toxic crayons, particularly for children. Therefore, we ask that minors be supervised by an adult during the coloring activity. Participating in this study poses no risks that are not ordinarily encountered in daily life.