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

ICR 201302-0925-009

OMB: 0925-0674

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
New
Form and Instruction
New
Supporting Statement B
2013-02-13
Supplementary Document
2013-02-27
Supplementary Document
2013-02-27
Supplementary Document
2013-02-13
Supporting Statement A
2013-02-13
IC Document Collections
ICR Details
0925-0674 201302-0925-009
Historical Inactive
HHS/NIH 18813
CLINICAL MYTH-TERIES: A VIDEO GAME ABOUT CLINICAL STUDIES (NHLBI)
New collection (Request for a new OMB Control Number)   No
Regular
Improperly submitted 03/28/2013
Retrieve Notice of Action (NOA) 02/28/2013
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

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.

US Code: 42 USC 285b-2 Name of Law: Information and Education, the Director of the Institute (NHLBI)
  
None

Not associated with rulemaking

  77 FR 35407 06/13/2012
78 FR 13351 02/27/2013
No

2
IC Title Form No. Form Name
Adolescents (Wave two) 2 Screen pre post eval
Adolescents (Wave One) 1 Qualtative Focus Group Discussion Guide and screener

Yes
Miscellaneous Actions
No
This is a new ICR.

$42,342
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Saleda Perryman

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
02/28/2013


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