Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 5:02 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT06408818
Description: Participants were grouped as dyads for the purposes of recruitment and analyses. Therefore, parent and child were grouped when reporting adverse events. Notably, there were no adverse events to report in any dyads, including among both parents and children.
Frequency Threshold: 0
Time Frame: Adverse event data was collected from pretest to posttest completion: approximately 4 weeks.
Study: NCT06408818
Study Brief: Study of an Online Program to Help Parents Talk With Their Tween Children About Health, Gender, Body-Image, and Relationships
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Program: Media Aware Parent -Tween Participants will have access to an intervention between pre-test and post-test assessments. The intervention, Media Aware Parent -Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. Media Aware Parent - Tween: Media Aware Parent - Tween, is an online program for parents of tweens ages 9-12 designed to help parents have effective conversations with their child about body image, sexual development, gender stereotypes, romantic relationships, and media. 0 None 0 196 0 196 View
Active Control Resource Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. Active Control Resource: Parents will have access to medically-accurate information about topics such as body image, sexual development, gender stereotypes, and romantic relationships. 0 None 0 194 0 194 View
Serious Events(If Any):
Other Events(If Any):