Scull, Tracy M. https://orcid.org/0000-0002-9894-8654
Dodson, Christina V. https://orcid.org/0000-0001-9284-0004
Evans-Paulson, Reina https://orcid.org/0000-0001-7397-6969
Reeder, Liz C.
Geller, Jacob
Stump, Kathryn N.
Kupersmidt, Janis B. https://orcid.org/0000-0002-0559-2610
Funding for this research was provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD099134)
Article History
Received: 8 November 2021
Accepted: 20 May 2022
First Online: 21 June 2022
Declarations
:
: This study protocol (Version 1) was approved by the innovation Research & Training Institutional Review Board (IRB) chaired by Dr. Barbara Davis Goldman on September 3rd, 2020. Informed consent will be obtained in accordance with 21 CFR Part 50 and the Declaration of Helsinki. The protocol is also designed to meet the Health and Human Services Regulations regarding the Protection of Human Subjects 45 CFR 46 – Subpart D.
: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results.
: All project team members are employees at a small business that has a financial interest in the sale of <i>Media Aware</i>. Their conflict of interest is minimal and is further minimized through the implementation of a number of procedures to maintain independence, including the following: (1) data collection will be conducted through use of a web-based software system—so that no experimenter bias is introduced at this stage, and (2) analyses will be reviewed by an independent statistician and archived.