CLINICAL MYTH-TERIES: A VIDEO GAME ABOUT CLINICAL STUDIES (NHLBI)

Forms and Documents

Document Name	Status
Form 2 Adolescents (Wave One and Two) Form and Instruction	New
Form 1 Guardian (Wave One and Two) Form and Instruction	New
Form 4 Adolescents (Wave Two) Form and Instruction	Modified
Form 3 Adolescents (Wave One) Form and Instruction	Modified
support_stmt_b myth.doc Supporting Statement B	2013-04-30
Attachment 7 - Focus Group Recruitment Letter.docx Supplementary Document	2013-04-30
Attachment 6 - Pre-Post Evaluation Recruitment Letter.docx Supplementary Document	2013-04-30
Attachment 4 - IRB.pdf Supplementary Document	2013-04-30
support_stmt_a myth.doc Supporting Statement A	2013-04-30

IC Document Collections

IC ID	Document Title	Status
206780	Adolescents (Wave One and Two) Form and Instruction	New
206779	Guardian (Wave One and Two) Form and Instruction	New
205981	Adolescents (Wave Two) Form and Instruction	Modified
205980	Adolescents (Wave One) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0674	ICR Reference No: 201305-0925-001
Status: Historical Active	Previous ICR Reference No: 201302-0925-009
Agency/Subagency: HHS/NIH	Agency Tracking No: 19422
Title: CLINICAL MYTH-TERIES: A VIDEO GAME ABOUT CLINICAL STUDIES (NHLBI)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/22/2013
	Date Received in OIRA: 05/03/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2016	36 Months From Approved
Responses	840	0	0
Time Burden (Hours)	424	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This project plans to develop a serious (educational) video game called Paper Kingdom for adolescents (8-14 years) to build upon core messages of the No More Hand Me Downs: Clinical Studies in Children web site supported by NHLBI. This game It will provide storylines with expeditions or pursuits where the player must help their 'brother' in the game take his medication. Through playing the game, users will encounter several obstacles which they must overcome and through which they will learn about clinical research. To complete each level they will demonstrate that they have understood the myths or misconceptions presented. In the end, they will help their brother through all of his concerns. Specific Aims of the study will be to: o Aim 1: Expand and refine Paper Kingdom game modules (content and direction) based on participatory evaluation with Scientific Advisors to address the Learning Objectives (LO). o Aim 2: Extend and refine Paper Kingdom game functionalities (usability and interactivity) based on feedback from the participatory evaluation from the Scientific Advisory Board, and focus groups with adolescents. Three focus groups with 10 participants each (n=30) are planned. o Aim 3: Evaluate the effectiveness of the Paper Kingdom approach to improving adolescent engagement, awareness, and knowledge about clinical studies in a pre/post randomized trial. We plan to recruit 250 adolescents for the evaluation. o Aim 4: Complete the final version of Paper Kingdom to be released to schools, health clinics, individuals and other interested parties.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 35407	06/13/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 13351	02/27/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Guardian (Wave One and Two)	1	Consent for participation in Research
Adolescents (Wave One and Two)	2	Assent for Participation in research Child
Adolescents (Wave One)	3	Qualitative Focus Group Discussion and Screener
Adolescents (Wave Two)	4, 5	Screen Pre Post Evaluation ,   Screenshots of the Pre Post Evaluation

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	840	0	0	840	0	0
Annual Time Burden (Hours)	424	0	0	424	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

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Annual Cost to Federal Government: $42,342

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/03/2013

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