UNIVERSITY OF WISCONSIN-MADISON Research Participant Information and Consent Form

Transcription

1 UNIVERSITY OF WISCONSIN-MADISON Research Participant Information and Consent Form Title of the Study: Grammatical Development in Boys with Fragile X Syndrome and Autism Principal Investigator: Audra Sterling, Ph.D. (phone: : asterling@waisman.wisc.edu) DESCRIPTION OF THE RESEARCH You are invited to participate in a research study about language development in boys with fragile X syndrome and/or autism. This study is called, "Grammatical Development in Boys with Fragile X Syndrome and Autism". The study is being done by Audra Sterling at the Waisman Center at the University of Wisconsin-Madison. You have been asked to participate because you have a son who is in the age range of study participants (9-16 years of age), and has fragile X syndrome or autism. Approximately 75 boys will participate in this study. The purpose of this research is to better understand how children with fragile X and children with autism use language. Through this study, we will be able to create a profile of strengths and weaknesses associated with the language development of children with FXS and children with autism. Specifically, we are interested in whether children with FXS and children with autism have difficulties in their use of verbs and verb endings (ex: he walks, he walked). This is a known problem for some children with language disorders. Given the delays in language in children with FXS, and some children with autism, the current study plans to see if children with FXS and children with autism also struggle with how they say and think about verbs. This information will help inform clinicians as to the best methods for assessment of language abilities. You and your child are being asked to participate in testing at the Waisman Center of the University of Wisconsin-Madison. Your child will be audio and video taped during his/her participation in this research. Only research personnel directly involved with this project will hear or see the recordings. We will keep the recordings in a locked cabinet Dr. Sterling s research lab. The tapes will be kept for an indefinite period of time so that we can use them in future studies to better understand language and learning problems. We will transcribe sections of these video/audio recordings, including the conversation language sample, the experimental task, and some of the standardized measures. These transcripts will be kept on a password protected secure server. Only individuals directly involved with the research study will have access to the transcripts. Your child s name will not be on the transcript. We will also transcribe the short interview we complete with you. This transcript will be kept on the same server,

2 and your name will not be listed on the transcript. The transcripts will be used to help us understand how your child uses language, and will be kept indefinitely. WHAT WILL MY CHILD S PARTICIPATION INVOLVE? If you decide to participate in this research you will be asked to come to the Waisman Center with your son and do these things: 1. Your son will be asked to complete a number of standardized tests, including a nonverbal IQ test (45 minutes), a language production test (15 minutes), a language comprehension test (15 minutes), two language tests focused on grammatical development (one hour). 2. We will complete a language sample with your son. This will involve a set of conversation topics, as well as asking him to retell a wordless picture book (25 minutes). 3. You and your son will be asked to complete an autism diagnostic assessment. We would like to do a behavioral assessment with your son (the Autism Diagnostic Observation Schedule: 45 minutes), and complete an interview with you (the Autism Diagnostic Interview: 2 hours). We will also ask you to complete a short 5 minute interview talking about your son. 4. Your son will also complete an experimental task in which he will be asked to imitate simple sentences and learn a new word or word form (35 minutes). The total time you and your child will be at the Waisman Center will be between 4 to 6 hours. We can schedule this for a one day period, or break this visit into two consecutive days. We will schedule frequent breaks in order to minimize frustration and fatigue during the session. We will audio and video record the sessions. The recordings will be kept indefinitely and may be used in future analyses. Any such analyses would be consistent with the goals of the study described in this letter. ARE THERE ANY RISKS TO MY CHILD? We don't anticipate any risks to you or your son, beyond the risks of daily life. Your son might get tired or frustrated with the testing. If so, your son can take a break or finish testing another time. ARE THERE ANY BENEFITS TO MY CHILD? You and your child are not expected to benefit directly from participating in this study. Your participation in this research study may benefit other people in the future by helping us learn more about the most effective methods for language assessments. COMPENSATION

3 You and your son will be paid $25 as a thank you for your participation. You will be paid regardless of whether your son completes the study protocol. HOW WILL MY CHILD S CONFIDENTIALITY BE PROTECTED? While there will probably be publications as a result of this study, your child s name will not be used. Only group characteristics will be published. WHOM SHOULD I CONTACT IF I HAVE QUESTIONS? You may ask any questions about the research at any time. If you have questions about the research after you leave today you should contact the Principal Investigator, Audra Sterling at If you are not satisfied with response of research team, have more questions, or want to talk with someone about your rights as a research participant, you should contact the Education Research and Social & Behavioral Science IRB Office at You and your child s participation are completely voluntary. If you decide not to participate or to withdraw from the study it will have no effect on any services or treatment you and/or your child are currently receiving. Your signature indicates that you have read this consent form, had an opportunity to ask any questions about your child s participation in this research and voluntarily consent to participate. You will receive a copy of this form for your records. Name of Participant (please print): Signature Date

4 Permission to be Contacted about Future Studies We would like your permission to contact you about other studies we conduct in the future and which might be of interest to you. Granting permission to contact you about future studies is optional, and you need not grant permission for your child to participate in the research. I agree to be contacted and receive information about future studies on fragile X syndrome, autism, or language development being conducted by Audra Sterling. I understand that agreeing to be contacted does not obligate me to participate. I also understand that I may rescind my permission to be contacted at any time. Signature Date Print Your Name

5 Form to Obtain Permission to Show Video of Child s Participation to Non-Project Audiences (e.g., at Professional Conferences)

6 Permission to Show Videos of Your Child s Participation in the Study on Language Development We often present the results of our research at seminars and conferences attended by other researchers, clinicians, educators, and families. It is sometimes useful to illustrate the methods and findings of our research by showing videos of children participating in the study as they complete our tests and activities. We are asking just a few families to show these videos. We would like your permission to show videos of your child for this purpose. Granting permission to show video recordings is optional, and you need not grant permission for your child to participate in the research. I agree to allow the video recordings of my child made in this study to be shown by Audra Sterling in presentations about the research project on language development and its findings. I also understand that I may rescind my permission at any time. Signature Date Print Your Name Print Your Child s Name