Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-24 @ 7:16 PM
Ignite Modification Date: 2025-12-25 @ 4:53 PM
NCT ID: NCT02684903
Description: Our definition of adverse event is consistent with clinicaltrials.gov, and is "an untoward or unfavorable medical occurrence in a study participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research." No adverse events occurred in this study.
Frequency Threshold: 0
Time Frame: Adverse event data were collected during the time frame encompassing data collection, from participant study entry through study completion, an average of 8 months.
Study: NCT02684903
Study Brief: Coaching Alternative Parenting Strategies (CAPS) Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Services As Usual (SAU) - Parents Participants receive all the usual services provided by DHS- Children's Services. 0 None 0 84 0 84 View
Services As Usual (SAU) - Children Participants receive all the usual services provided by DHS- Children's Services. 0 None 0 84 0 84 View
Parent-Child Interaction Therapy (PCIT) Engagers Only - Parents All participants randomized to PCIT condition who engaged in 1+ sessions. 0 None 0 79 0 79 View
Parent-Child Interaction Therapy (PCIT) Engagers Only - Children All participants randomized to PCIT condition who engaged in 1+ sessions. 0 None 0 79 0 79 View
Parent Child Interaction Therapy (PCIT) - Parents Participants randomized to receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. Parent Child Interaction Therapy: PCIT is a 16-20 session live-coaching parenting intervention. PCIT for Child Welfare families is delivered in two sequential treatment phases following a motivational enhancement training: Phase 1, Child-Directed Interaction (CDI) to enhance positive parenting and interrupt harsh aversive parenting, and Phase 2, Parent-Directed Interaction (PDI) to coach effective parent commands and a consistent time-out protocol when child disobeys. 0 None 0 120 0 120 View
Parent Child Interaction Therapy (PCIT) - Children Participants randomized to receive Parent Child Interaction Therapy (PCIT). PCIT is designed to improve child functioning by interrupting patterns of harsh, coercive interaction and enhancing parents' warm, positive parenting, autonomy support, and competent child management skills. Parent Child Interaction Therapy: PCIT is a 16-20 session live-coaching parenting intervention. PCIT for Child Welfare families is delivered in two sequential treatment phases following a motivational enhancement training: Phase 1, Child-Directed Interaction (CDI) to enhance positive parenting and interrupt harsh aversive parenting, and Phase 2, Parent-Directed Interaction (PDI) to coach effective parent commands and a consistent time-out protocol when child disobeys. 0 None 0 120 0 120 View
Serious Events(If Any):
Other Events(If Any):