Form 1 Consent Form

Attachment 14

Consent and permission forms

OMB Control Number: 0925-XXXX Expiration Date: 09/13/2014

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-XXXX). Do

not return the completed form to this address.

OMB #: 0925-NEW

Expiration Date: 09/13/2014

innovation Research & Training, Inc.

Address: 1415 W NC Highway 54, Suite 121, Durham, NC 27707

Voice: 919 493-7700 Fax: 919 493-7720

Dear Parent or Guardian,

We are inviting you and your child to participate in a research project. This project is funded by the National Institute on Drug Abuse, the National Institutes of Health. This letter tells you more details about what participation in this research project would be like.

Please read this letter to be sure you know what will take place and what we will be asking you and your child to do, so you can decide if you both want to be a part of the project. Please let us know if you have questions after reading this letter.

What is this project about?

In general, we are interested in how families use media together (e.g., computers, televisions, video games, and mobile devices). In this study, we are specifically interested in whether using media together as a family can have a positive effect on children’s health and reduce children’s substance use experimentation. We would like to study family interaction surrounding the use of a computer program designed for families to use together. Some computer programs may be CD-based and others may be web-based. We are asking for you and your child to try out one of these computer programs and provide us with feedback on your experiences.

What will we do as part of the project?

1. You and your child will meet a project staff member at a location in your community. Each of you will complete a baseline questionnaire. This should take less than 45 minutes.

2. You and your child will be randomly assigned to use one of two computer programs at home. The CD-based computer program is called Family Game Night and the web-based computer program is called Media Detective Family. If you get Family Game Night, you will be asked to play the game together with your child for 3 hours over the course of a one-month period. If you get Media Detective Family, you will be asked to complete the web-based program together with your child over the course of a one-month period. Completing Media Detective Family could take about 3 hours.

3. You will be asked to fill out a form to track your use of the computer program. The form will ask about the number of times you used the program, how long you used the program each time (duration), and the people who used the program. You will need to bring this completed form with you when you come for the 1-month and 3-month follow-up data collection visits.

OMB #: 0925-NEW

Expiration Date: 09/13/2014

4. The computer program to which you are randomly assigned may collect some information on your use of the program. This may include times and dates of use, answers to interactive portions of the program, the amount of the total program completed, the IP address from which you connected to the online portion, and the type of Internet browser you used (if any). These data will only be viewable to the research and program development staff at iRT.

5. You and your child will meet a project staff member at a location in your community to complete a second set of questionnaires approximately 1 month after you completed the baseline questionnaire. This should take less than 45 minutes.

6. You and your child will meet a project staff member at a location in your community to complete a final set of questionnaires approximately 3 months after you completed the second questionnaire. This should take less than 45 minutes.

Please note:

• The same parent and child must complete the questionnaires at each time point.

• The entire family is welcome to use the program together, but both the parent and the child who are participating in this research study must always be present when the computer program is used.

• In the questionnaires, you and your child will be asked about your thoughts, attitudes, and behaviors. This includes use of alcohol and tobacco products, use of media and technology, and thoughts and attitudes about media and advertising. You and your child complete separate questionnaires, and each of you can skip any question that you do not want to answer and quit at any time that you want for any reason.

Will our answers be kept private?

Your answers will be kept private. All data will be kept secure at iRT in locked file cabinets or on password-protected servers. Only iRT staff members who work on this project will be able access the data. Unique “secret numbers” will be used in place of names on the questionnaires. A link between your names and the unique secret numbers will be kept secure at the iRT office. Once the study concludes, the link will be destroyed and the data will then be completely anonymous.

What happens if we don’t want to be a part of the project?

It is up to you to choose if you want to be a part of the project or not. Nothing bad will happen to you or your child if either of you decide not to participate. Both of you can skip any question that you do not want to answer and quit at any time that you want for any reason. Even if you give your permission for your child to participate, he or she can still choose not to participate.

Are there any risks to being in the project?

No risks are foreseen to you or your child from participating in the study. You and your child may refrain from any answering any question that you do not want to answer. You and your child may also leave the study at any time without consequence.

OMB #: 0925-NEW

Expiration Date: 09/13/2014

Will anything good happen as a result of being in the project?

Your thoughts and ideas, along with your child’s, will help us develop better computer programs for families so that more families can benefit from them in the future. We hope that you and your child will enjoy the time that you spend together completing your assigned program.

Will we get anything for doing this project?

YES. Your family will receive a $20 incentive for completing the baseline questionnaire; a $5 incentive for completing the assigned computer program; a $30 incentive for completing the 1-month follow-up; and a $40 incentive for completing the 3-month follow-up (possible total of $95). You will also receive reimbursement for mileage between your home and the data collection site.

If I have a question about the project, who do I ask?

The project is being done by Dr. Tracy Scull and Dr. Janis Kupersmidt of innovation Research and Training, Inc. If you have any questions about the study, please contact Dr. Scull by email ([email protected]) or by phone (919) 493-7700.

If you have any questions or concerns about your rights, or your child’s rights, as research participants, or how you were treated, you should contact Barbara Davis Goldman, Ph.D., Chair of the iRT Institutional Review Board (IRB), at [email protected] or 919-966-7169.

We hope you and your child will agree to be a part of this project.

Sincerely,

Tracy Scull, Ph.D. Janis Kupersmidt, Ph.D.

Principal Investigator Co-Investigator

OMB #: 0925-NEW

Expiration Date: 09/13/2014

Family Media Project

PARENT PERMISSION AND CONSENT

The goal of this project is to examine family interaction surrounding the use of a computer program designed for families to use together.

In this study, you and your child will be asked to:

• Meet with a project staff member to complete three questionnaires each over a period of four months, and

• Use a computer-based program together.

Participation is voluntary and participants can stop at any time. All responses will be kept confidential.

In order to participate, please check both boxes below and fill out the additional information.

• I give permission for my child to participate in the Family Media Project.

• I consent to participate in the Family Media Project.

Your name (signature): _______________________________________ Date: ___________________

Your name (please print): _______________________________________

Mailing address: ____________________________________

____________________________________

____________________________________

Phone number: __________________________ Email address: ____________________________________

Child’s name (please print): ________________________________

KEEP ONE COPY OF THE FORM AND GIVE THE SIGNED FORM TO THE RESEARCHER