1.2 LOI2 QUEX-8 Exemplar Telephone Script

OMB #: 0925-0661
Expiration Date: 6/30/2015

Attachment 2 LOI2-QUEX-8 - Exemplar Telephone Script

Protocol Title: NCS Formative Research Project #8 – Development and Validation of Autism Case Confirmation Approaches for Use
in the National Children’s Study
Application No.: NA_00046473
Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP
Date: July 28, 2011

Kennedy Krieger Institute
CONSENT SCRIPT TO SCREEN FOR RESEARCH
Participants Scheduled or Waiting to be Scheduled for a Clinical Assessment at Kennedy
Krieger Institute
NCS Formative Research Project #8 – Development and Validation of Autism Case
Confirmation Approaches for Use in the National Children’s Study

Kennedy Krieger Institute Center for Autism and Related Disorders Research Team
Member
Hello, my name is ______________ from the Center for Autism and Related Disorders at
the Kennedy Krieger Institute.
Kennedy Krieger Institute Center for Development and Learning (CDL) Research
Team Member
Hello, my name is ______________ from the Center for Development and Learning at
the Kennedy Krieger Institute.

I am calling you about the study in which you had expressed some interest, titled
Development and Validation of Autism Case Confirmation Approaches for Use in the
National Children’s Study. Is this is a good time to speak now? [If so, continue script.
If not, ask when would be a better time, thank them for their time and end call]. I
need to ask you a few questions in order to determine whether your child and you may be
eligible for this research study. I will ask you general questions about your child’s
development and medical history. Before I begin I would like to tell you a little bit about
the research.
This research is being done to examine three new ways to possibly identify children with
autism spectrum disorders (ASD). If one or more of these new ways are able to identify
children with ASD, they might be used in the National Children’s Study (NCS) protocol.
If you are eligible for this study and if you agree to do so, you and your child will come
into our Center for a three hour visit. This visit, which will be at least one week before
your scheduled clinic visit, will consist of a parent interview, a computerized parent
questionnaire, and a child play assessment. Your second visit will be your scheduled
clinic visit. After this second visit, we will follow up with the clinician who will be
working with you and your child regarding the diagnosis given by that clinician.
Would you like to continue with the screening? The screening will take about 5 minutes
and we will be collecting information about you. You do not have to answer any
questions you do not wish to answer and you may stop at any time. Your participation in
the screening is voluntary. Your information will only be seen by the research team. We
Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the
data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently
valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch,
6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0661). Do not return the completed form to this address.

Page 1 of 4
Telephone Screening Script June 2008 Version 1

Protocol Title: NCS Formative Research Project #8 – Development and Validation of Autism Case Confirmation Approaches for Use
in the National Children’s Study
Application No.: NA_00046473
Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP
Date: July 28, 2011

try to make sure that the information we collect from you is kept private and used only
for the research study we are discussing. If you do not agree to continue the phone call, it
will not affect your care at Johns Hopkins or at the Kennedy Kreiger Institute.
If your child does not qualify for the study, we will destroy the information we have. If
your child does qualify for the study and you agree to participate, we will schedule the
visit to our Center. It is at that point, you will sign the research informed consent form.
Would you like to continue with the screening?
[if no, thank the person and hang up]
[if yes, continue with the screening.]
Please answer the following 6 questions individually. After each question please respond
with a “yes” or “no” answer.
1. Does your child have a clinical diagnosis of autism or PDD-NOS or autism spectrum
disorder or Asperger’s syndrome?
YES

NO

[Note to research staff: If the answer is yes to the above question, he/she does not meet
eligibility requirements for the study. You may discontinue the screening and say:
“Thank you for your interest in this study. Due to your child’s previous diagnosis of
autism, your child does not meet eligibility criteria. Would you like to receive
information about assessment services within Kennedy Krieger Institute?”
If the answer is no to the above question, he/she currently meets eligibility for the study
and you can continue with the questions below.
If the child is scheduled or waiting to be scheduled for a visit to the Kennedy Krieger
Institute Center for Autism and Related Disorders, ask questions 2A and 2B to
confirm. If the child is scheduled or waiting to be scheduled for a visit to the Center for
Development and Learning, ask question 3A-3C to confirm.]
2A. Are you currently scheduled or waiting to be scheduled for an autism evaluation at
the Center for Autism and Related Disorders at Kennedy Krieger Institute?
YES

NO

2B. Is your child between the ages of 30 and 39 months at the time of this scheduled
visit?
YES

NO

Page 2 of 4
Telephone Screening Script June 2008 Version 1

Protocol Title: NCS Formative Research Project #8 – Development and Validation of Autism Case Confirmation Approaches for Use
in the National Children’s Study
Application No.: NA_00046473
Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP
Date: July 28, 2011

[If the answer is no to either of the above questions (2A, 2B) and he/she also is not
scheduled or waiting to be scheduled for a visit to the Center for Development and
Learning, he/she currently does not meet eligibility for the study. You may discontinue
the screening and say: “We appreciate your time but because you responded “no” to
one or more of the questions, we are unable to enroll you in this project.”
If the answer is yes to both questions above (2A, 2B), he/she currently does meet
eligibility for the study and you may ask question 4.]
3A. Are you currently scheduled or waiting to be scheduled for an evaluation at the
Center for Development and Learning at Kennedy Krieger Institute?
YES

NO

3B. Do you have any concerns that your child might have autism?
YES

NO

3C. Is your child between the ages of 30 and 39 months at the time of this scheduled
visit?
YES

NO

[If the answer is no to question 3C, he/she currently does not meet eligibility for the
study. You may discontinue the screening and say: “We appreciate your time but
because you responded “no” to one or more of the questions, we are unable to enroll
you in this project.”
If the answer is yes, he/she currently does meet eligibility for the study and you may
ask the next question.]
4. Is English the primary language spoken in the home?
YES

NO

[If the caregiver answers “no” to questions 4, the child does not meet the eligibility
requirements for this study, say, “We appreciate your time but because you responded
“no” to one or more of the questions, we are unable to enroll you in this project.”
Please continue if the caregiver answers “yes” to all questions. ]
Thank you for answering the screening questions.
We appreciate your time. We have determined that your child and you are eligible for the
study. I would like to tell you a little bit more about the study.

Page 3 of 4
Telephone Screening Script June 2008 Version 1

Protocol Title: NCS Formative Research Project #8 – Development and Validation of Autism Case Confirmation Approaches for Use
in the National Children’s Study
Application No.: NA_00046473
Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP
Date: July 28, 2011

All research studies have some degree of risk or discomfort. Time burden and discomfort
during interviews using sensitive questions are common risks and discomforts of minimal
risk studies such as this. You may choose not to answer any questions that you do not
wish to answer. Also, your child may get tired during the play-based testing, at which
time your child would be given a break to rest or have a snack. We will also be flexible as
possible when scheduling testing to address these risks.
There are no direct health benefits for you or your child from this study. However, your
participation in this study will help the National Children’s Study investigate autism more
effectively.
There are not any costs to participants except those of transportation. You will be
provided $50 for your time and travel costs.
Do you have any questions about the screening or the research study?
Do you think you would like to take part in this research?
[if no, thank the person for their time and hang up]
[if yes] We would like to schedule you and your child for your visit to our Center. We
would also like to send you a consent form to review prior to your visit to the center.
I am going to give you a couple of telephone numbers to call if you have any questions
later. Do you have a pen? If you have questions about the research study, you may call
Sarah Warnet at 443-923-7644 and she will answer your questions.
If you have questions about your rights as a research subject, please call the Johns
Hopkins Medicine Office of Human Subjects Research at 410-955-3008.
Thank you again for your willingness to answer our questions.

Caller’s Name_____________________________________
Parent’s Name_____________________________________
Child’s Name______________________________________
Date and Time_____________________________________

Qualify for Study?

YES

NO

Page 4 of 4
Telephone Screening Script June 2008 Version 1