Assessment of Executive Function for the National Children's Study

Attach. 16 Consent Form Delve with 2^nd Session OMB #: 0925-0661

Executive Function Expiration Date: 06/30/2015

PARENT CONSENT AND PERMISSION FORM

Assessment of Executive Function for the National Children’s Study

You are invited to be in a research study about the development and measurement of attention, self-control, and child personality. Your child was selected as a possible participant because your child is between 2 ½ to 5 ½ years old and you previously indicated interest in research opportunities. Your family also was chosen randomly to participate in a second session if you would like to.

This study is being conducted by Professors Ann Masten, Philip Zelazo, and Stephanie Carlson in Child Development at the University of Minnesota with the help of Delve Market Research.

Background Information

The purpose of this study is to develop brief measures of executive function skills and child personality for the National Children’s Study. Executive function skills include thinking in flexible ways, paying attention, and remembering rules. The National Children’s Study is a planned study of children from before birth to age 21 designed to study health and development in children across the United States. To get ready for this large study, we are trying to design short and appealing measures with the help of families in several states.

Procedures:

If you agree to be in this study, we would ask you and your child to do the following things:

First Session

As a parent, you would be asked to complete questionnaires about your child and family background. We would ask you questions about your family history, your child’s development and behavior, and also what your child is generally like (such as whether your child is quiet or active, can take turns when playing a game, gets frustrated easily or not). This part of the session takes about 45 minutes.

Your child will also play a variety of games. In the computer games that measure attention and thinking, your child would sort objects by shape or color and feed fish. Children also will complete brief tasks to measure thinking skills and school readiness, such as assembling blocks into patterns, counting, and identifying letters. The child’s session will take about an hour.

Second Session in 1 or 2 weeks

The purpose of the second session is to see whether there are changes in scores over short periods of time in these measures. Parents would be asked to complete two of the same questionnaires about their child’s behavior which would take 10 to 15 minutes. Children would be asked to repeat some of the games, during a session of about 30 minutes.

Risks and Benefits of Being in the Study:

The study has minimal risks for parents or children. Some of the questions may remind you of challenging behaviors of your child. Also, children could become frustrated by some of the tasks. Parents may choose not to answer any question. If a child seems too tired or distressed to continue at any time, we would stop the session.

There are no benefits to participation in this study.

Compensation:

Parents who participate will receive payments to thank them their time for each session. Parents who complete a session will receive a $50 Delve debit card. If a parent chooses to stop early, payment will correspond to the portion completed. Children will receive a $25 Delve debit card.

Privacy:

Within the limits permitted by law, the records of this study will be kept private to the extent permitted by law. In any sort of report about the study, there will be no information to identify you or your child. Research records will be stored securely and only researchers will have access to the records.

You should be aware that there are legal limits to our ability to keep certain information about you private. If we were to learn that a child is being harmed or that a parent or child seriously intended to harm themselves or someone else, we would be required to report this situation.

Voluntary Nature of the Study:

Participation in this study is voluntary. Your decision about whether or not to participate will not affect your current or future relations with the University of Minnesota or Delve. If you decide to participate, you are free to choose not to answer any question or withdraw at any time without affecting those relationships.

Contacts and Questions:

The researchers conducting this study are Professors Ann Masten, Philip Zelazo, and Stephanie Carlson. You may ask any questions you have now. If you have questions later, you are encouraged to contact them at the University of Minnesota. The best way to reach them is to call Professor Masten in the Institute of Child Development.

Telephone for Ann Masten: 612-624-0215. Email for Ann Masten: [email protected]

If you have any questions or concerns regarding this study and would like to talk to someone other than the researcher(s), you are encouraged to contact the Research Subjects’ Advocate Line, D528 May, 420 Delaware St. Southwest, Minneapolis, Minnesota 55455; (612) 625-1650.

You will be given a copy of this information to keep for your records.

Statement of Consent:

I have read the above information. I have asked questions and have received answers. I consent to participate in the study and I give permission for my child to participate in the study.

Child’s Name: ______________________________________________

Signature of Parent or Guardian: ______________________________ Date: ____________

Signature of Investigator: ____________________________________ Date: ____________

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.

IRB Code # 1101S94592

Version Date: TBA 1 of 3