Review of Enrollment and Informed Consent or Assent/In-person Assessment of Intellectual abilities

Form Approved
OMB No. 0920-xxxx
Exp. Date: xx/xx/xxxx

Attachments 8c-8d-8e-8f-8g: Review of Enrollment and Informed Consent or Assent,
In-person Assessment of Intellectual Abilities

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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 CDC/ATSDR Reports Clearance
Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0010).

Study to Explore Early Development (SEED) Follow-up Studies
Informed Consent Form for Parents and Legal Guardians
Thank you for your recent participation in the SEED Follow-up Studies. You are being invited to be in
another part of this research study. The SEED Follow-up Studies are funded by the Centers for Disease
Control and Prevention (CDC). CDC is a federal agency that works to improve the health and safety of
people. CDC is working with research partners across the country to conduct the study. Your
participation will help us learn how we can support different types of children and families as they
grow older.
What is the purpose of the study?
The SEED Follow-up Studies look at changes that happen between the preschool years and
adolescence and young adulthood. Some of the changes we are interested in are health, healthcare,
safety, services, and treatments. Another is how learning abilities change over time. We are inviting
you to this part of the study on changes in learning abilities now.
One of our goals is to better support people with autism and other developmental delays or disabilities
as they grow older. To reach our goals, we need different types of people and families to participate in
the study.
Why am I being asked to be in this part of the study?
You are being invited to take part in this study because you participated in SEED in the past.
Specifically, your child completed an evaluation of early learning abilities between 2 and 5 years of
age. Recently, you also completed a survey about your child’s current health and development.
What will my child have to do to be in this part of the study?
Your child will be asked to complete an evaluation of learning abilities. This involves answering
questions and completing activities like puzzles. It also involves comparing pictures presented on an
iPad. The evaluation will take up to 1.5 hours. Your child can stop the evaluation at any time without
penalty.
Why should my child be in this part of the study?
There is no personal benefit for being in this part of the study. Your child’s participation will help us
learn more about how learning abilities change over time. This information may be used to help
people with autism and other developmental delays and disabilities. One way to help people with
autism and other developmental delays and disabilities is to offer better services and treatments.
Are there any risks involved with this part of the study?
There is little risk involved with the evaluation. Your child may feel nervous working with a new
person. The person who gives the evaluation will make sure your child is comfortable before testing
begins. Your child may become tired during the evaluation. Short breaks will be given as needed. You
will receive written results from the evaluation. You may get feedback that is unexpected and/or
shows

below average skills. We will tell you how to contact someone if you have questions. You are also
encouraged to share results with your healthcare provider.
Is this going to cost me anything?
There are no costs for being in this part of the study.
Will I get anything after the evaluation?
You will receive a $45 gift card for being in this part of the study. The gift card is to thank you for your
participation. It can also be used to cover travel expenses.
You will receive written results within one month of the evaluation. The letter will explain each test
given to your child. It will explain your child’s scores on each test. It will tell you how your child
performed compared to other people the same age. We encourage you to share these results with
your healthcare provider.
We will send you a study newsletter up to two times per year. It will be emailed to you, or you can find
it on our website at SEED Newsletter | CDC. It will tell you what we are learning from the study.
Will my child’s information I give be kept confidential?
Any information that identifies your child will be kept confidential unless otherwise required by law. A
study ID will be assigned to evaluation results. Only people working on the study will be able to link
study IDs to names. The link will be kept on a password-protected computer. Evaluation forms will be
kept in locked cabinets in locked offices.
We may share some information with other researchers. They will be approved by our team. They will
not be able to link study IDs to names.
We will never use your child’s name in any report. The information you give will always be combined
with information from all other participants in reports.
Does my child have to be in this part of the study?
The decision to be in this part of the study is up to you. Your child’s participation is voluntary. If you
decide to participate and change your mind, your child can drop out of the study at any time. We will
still use the information your child gave us unless you tell us not to use that information.
Your child’s school and healthcare services will not be affected if you decide not to be in the study. We
will not discuss your decision to participate or not to participate with anyone outside the study.
Who can I call if I have questions?
If you have questions about the study, you can call at .
If you feel you have been harmed by participating in this part of the study, please contact at . If you have questions about your rights as a research
participant, you can call the at .
We will give you a copy of this consent form to keep.
Informed Consent Statement for Parents of Children Younger than 18 Years
I have been told about the study. I know what is expected of my child. I was allowed to ask questions. I
had all my questions answered. I give permission to enroll my child in this part of the study.
_________________________________
Signature of parent

____________________
Date/Time

_________________________________
Printed name (parent)

_________________________________
Printed name (child)

_________________________________
Signature of witness

____________________
Date/Time

_________________________________
Printed name (witness)
Informed Consent Statement for Legal Guardians of Young Adults 18 Years and Older
I have been told about the study. I know what is expected of my child. I was allowed to ask questions. I
had all my questions answered. I give permission to enroll my child in this part of the study.
_________________________________
Signature of parent

____________________
Date/Time

_________________________________
Printed name (parent)

_________________________________
Printed name (child)

_________________________________
Signature of witness

____________________
Date/Time

_________________________________
Printed name (witness)

Study to Explore Early Development (SEED) Follow-up Studies
Assent Form for Children
We are asking you to be in a study. This study is by the Centers for Disease Control and Prevention
(CDC). CDC wants to make people healthy and safe. CDC is working with research partners across the
country to do the study. This form tells you more about the study.
What is this study about?
This is a study about how people learn. We want to see how people learn early and later in life.
Why do you want me to be in the study?
You were in a study when you were 2-5 years of age. We looked at how you learn. We now want to
look at how you learn again. We will use this information to help people. Some of the people we help
have different ways of learning.
What will I have to do?
You will be asked some questions. You will be asked to do activities like puzzles. You will also be asked
to look at pictures on an iPad. The test will take about one hour. You can take a break or stop at any
time.
Will I be hurt?
You might feel nervous. We will make sure you are calm and happy. You might get tired. You can take
breaks or stop at any time. You will not be hurt.
Why should I be in the study?
You will not get anything from being in the study. You can help us learn about different ways people
think. We use this information to make sure people get the help they need.
Will you tell anyone about this study?
We will only tell your parent(s) about the study. Your parents might tell your doctor or your school. We
will not use your name in the study.
Do I have to be in the study?
You do not have to be in the study if you do not want. You can drop out of the study at any time.
What if I have questions?
You can ask the person who gave you this paper any questions. You can also ask your parent(s). Your
parents have agreed for you to be in the study.

Agreement
I have been told about the study. I know what to do. I was allowed to ask questions. I had all my
questions answered. I agree to be in this study.
_________________________________
Signature of participant

____________________
Date/Time

_________________________________
Printed name (participant)
_________________________________
Signature of witness
_________________________________
Printed name (witness)

____________________
Date/Time

Study to Explore Early Development (SEED) Follow-up Studies
Informed Consent Form for Young Adults
You are invited to be in a research study. This study is funded by the Centers for Disease Control and
Prevention (CDC). CDC is a federal agency that works to improve the health and safety of people. CDC
is working with research partners across the country to conduct the study. Your participation will help
us learn how we can support different types of children and families as they grow older.
What is the purpose of the study?
This is a study on changes that happen between the preschool years and adolescence and young
adulthood. Some of the changes we are interested in are health, healthcare, safety, services, and
treatments. Another is how learning abilities change over time. We are inviting you now to this part of
the study to look at changes in learning abilities.
One of our goals is to better support people with autism and other developmental delays or
disabilities as they grow older. To reach our goals, we need different types of people and families to
participate in the study.
Why am I being asked to be in this part of the study?
You are being invited to take part in this study because you participated in SEED in the past.
Specifically, you completed an evaluation of early learning abilities between 2 and 5 years of age.
Recently, your parent also completed a survey about your current health and development.
What will I have to do to be in this part of the study?
You will be asked to complete an evaluation of learning abilities. This involves answering questions
and completing activities like puzzles. It also involves comparing pictures presented on an iPad. The
evaluation will take about one hour. You can stop the evaluation at any time without penalty.
Why should I be in this part of the study?
There is no personal benefit for being in this part of the study. Your participation will help us learn
more about how learning abilities change over time. This information may be used to help people with
autism and other developmental delays and disabilities. One way to help people with autism and other
developmental delays and disabilities is to offer better services and treatments.
Are there any risks involved with this part of the study?
There is little risk involved with the evaluation. You may feel nervous working with a new person. The
person who gives the evaluation will make sure you are comfortable before testing begins. You may
become tired during the evaluation. Short breaks will be given as needed. You will receive written
results from the evaluation. You may get feedback that is unexpected and/or shows below average
skills. We will tell you how to contact someone if you have questions. You are also encouraged to
share results with your healthcare provider.

Is this going to cost me anything?
There are no costs for being in this part of the study.
Will I get anything after the evaluation?
You will receive a $45 gift card for being in this part of the study. The gift card is to thank you for your
participation. It can also be used to cover travel expenses.
You will receive written results within one month of the evaluation. The letter will explain each test
you completed. It will explain your scores on each test. It will tell you how you performed compared to
other people the same age. We encourage you to share these results with your healthcare provider.
We will send you a study newsletter up to two times per year. It will be emailed to you, or you can find
it on our website at SEED Newsletter | CDC. It will tell you what we are learning from the study.
Will my information I give be kept confidential?
Any information that identifies you will be kept confidential unless otherwise required by law. A study
ID will be assigned to evaluation results. Only people working on the study will be able to link study IDs
to names. The link will be kept on a password-protected computer. Evaluation forms will be kept in
locked cabinets in locked offices.
We may share some information with other researchers. They will be approved by our team. They will
not be able to link study IDs to names.
We will never use your name in any report. The information you give will always be combined with
information from all other participants.
Do I have to be in this part of the study?
The decision to be in this part of the study is up to you. You participation is voluntary. If you change
your mind, you can drop out of the study at any time.
Any services you receive will not be affected if you decide not to be in the study. We will not discuss
your decision to participate or not to participate with anyone outside the study.
Who can I call if I have questions?
If you have questions about the study, you can call at .
If you feel you have been harmed by participating in this part of the study, please contact at . If you have questions about your rights as a research
participant, you can call the at .

We will give you a copy of this consent form to keep.
Informed Consent Statement
I have been told about the study. I know what is expected. I was allowed to ask questions. I had all my
questions answered. I agree to be in this part of the study.
_________________________________
Signature of participant

____________________
Date/Time

_________________________________
Printed name (participant)
_________________________________
Signature of witness
_________________________________
Printed name (witness)

____________________
Date/Time

Task Description: The NIHTB Pattern Comparison Processing Speed Test requires participants to identify whether two visual patterns

are the “same” or “not the same” (responses were made by pressing a “yes” or “no” button). Patterns were either identical or varied on
one of three dimensions: color (all ages), adding/taking something away (all ages), or one versus many (only ages 8–15 years; see
Figure 1). Scores reflected the number of correct items (of a possible 130) completed in 90 s; as described above, items were designed
to minimize the number of errors that were made (i.e., items with less than 75% accuracy during development were not included in the
final version of this task). This test takes approximately 3 min to administer.
Reference:
Carlozzi, N. E., Tulsky, D. S., Chiaravalloti, N. D., Beaumont, J. L., Weintraub, S., Conway, K., & Gershon, R. C. (2014). NIH toolbox cognitive
battery (NIHTB-CB): the NIHTB pattern comparison processing speed test. Journal of the International Neuropsychological Society, 20(6), 630641.