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 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
NCT ID:
NCT03925220
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse event data were collected over 24 months (from randomization through study completion date) for parent and child participants, and no adverse events were reported.
Study:
NCT03925220
Study Brief:
Testing a Brief Substance Misuse Preventative Intervention for Parents/Guardians of 5th-7th Grade Students
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Substance Use Prevention Intervention - Parents | Parents were given a handbook specific to the gender of their child that provides information and advice communication and substance use prevention. Parents then participated in a one-hour session with an interventionist where the main points in the handbook were reviewed and they filled out an action plan on how to make changes in communication about substances with their child. The interventionist also provided parents with a referral packet. Two weeks after the live session, participants had a half-hour follow-up phone call with the same study interventionist. For the home-based component, parents received two messages each week with reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators. The SUPPER Project: Substance Use Promoted by Eating family meals Regularly | 0 | None | 0 | 201 | 0 | 201 | View |
| Substance Use Prevention Intervention - Children | Children discussed with their parents a handbook specific to their gender that provides information and advice on communication and substance use prevention. Children participated with their parents in completing an action plan on how to make changes in communication about substances. Children received reminders and tips that reinforce the information covered in the handbook. Finally, participants received a magnet about the importance of family meals that they were instructed to put on their refrigerators. | 0 | None | 0 | 201 | 0 | 201 | View |
| Nutrition, Physical Activity, and Weight Talk Comparison - Parents | For the comparison condition, after the baseline assessment, parents received a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Parents also received a magnet with a message about nutrition and exercise. To control for contact time, these participants met live with a study staff member two weeks after receiving the handbook, completed an action plan, and had the 30-minute call, as well as receive two text messages twice per week for 13 weeks with tips and reminders from the comparison handbook and insert. Improving nutrition and physical activity among youth: A brief intervention focused on improving nutrition and physical activity among youth | 0 | None | 0 | 201 | 0 | 201 | View |
| Nutrition, Physical Activity, and Weight Talk Comparison - Children | Children discussed with their parents a handbook on nutrition and physical activity entitled: "Healthy Eating \& Physical Activity Across Your Lifespan: Helping your Child - Tips for Parents". This handbook, which is adapted from the handbook developed by the National Institute of Diabetes and Digestive and Kidney Diseases and the Weight Control Information Network, is approximately the same length as the intervention handbook and is available in English and Spanish. It is given with an insert on reducing weight talk and weight teasing in the family. Participants also received a magnet with a message about nutrition and exercise. Children also helped their parents complete an action plan and received tips and reminders from the comparison handbook and insert. | 0 | None | 0 | 201 | 0 | 201 | View |
Serious Events(If Any):
Other Events(If Any):