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Article History

Received: 28 May 2021

Accepted: 25 June 2021

First Online: 10 July 2021

Declarations

:

: The study has been approved by the Institutional Review Board (IRB) Office of Northwestern University (NU) STU00209764. The IRB Office of NU has reviewed and approved all modifications to the study protocol (current version 15 dated 2/4/2021) and/or study documents, and any future modifications will be submitted for review and approval. Online written or oral informed consent was received by all study participants in the study. A waiver of written documentation of consent and a waiver of assent for the children participating in the observational assessments were approved for this study by the IRB at NU. The waiver of written documentation of consent was approved in order to administer the study online or over the phone due to time and feasibility constraints of conducting a study of this magnitude with over 1,000 study participants located throughout seven states. The IRB felt written consent was not necessary due to the minimal risk of the research and the implementation of internet based and telephone surveys, without a written record, that could identify study participants. The waiver of assent was approved as the children who participated in observational assessments were 4.5 years and younger and do not have the capacity and capability to provide meaningful assent. It is stated in the mothers’ consent forms that they may be asked to participate in observational assessments with their child and that the observations are not mandatory. No minors were enrolled in the study. Consent was documented on an online consent form through a secure web-based application, Research Electronic Data Capture (REDCap). A web-link to the consent form was sent to eligible and interested study participants via text or email, or was completed over the phone with a member of the research team if a participant preferred oral administration.

: Not applicable.

: Not applicable.