- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05803265
Children Witnessed Violence Evaluated in a Pediatric ED
April 6, 2023 updated by: IRCCS Burlo Garofolo
Prevalence of Children Witnessed Violence Evaluated in a Pediatric Emergency Department
Witnessed violence is a form of child abuse with detrimental effects on child wellbeing and development, whose recognition relies on the assessment of their mother exposure to intimate partner violence (IPV).
The aim of this cross-sectional study is to assess the frequency of witnessed violence in a population of children attending a pediatric emergency department (ED) in Italy, by searching for IPV in their mother, and to define the characteristics of the mother-child dyads.
Study Overview
Status
Completed
Conditions
Detailed Description
Witnessed violence is a form of child abuse, consisting of the child experience of any kind of maltreatment against his/her parents/caregivers/family members, and can be either direct (if the maltreatment takes place in the child presence) or indirect (if the child is aware of the maltreatment and perceives its acute/chronic, physical/psychological effects).
The recognition of children witnessed violence requires the previous assessment of their mothers' exposure to intimate partner violence (IPV), defined by the World Health Organization (WHO) as a "behavior within an intimate relationship that causes physical, sexual, or psychological harm, including acts of physical aggression, sexual coercion, psychological abuse and controlling behaviors" committed by a current or former partner.
According to the WHO reports, one in three women is subjected to IPV, and it has been estimated that among children living in households where IPV takes place, 85% are direct witnesses to violence, and up to one half undergo direct forms of abuse, mostly by the father or any other male family member.
Exposure to IPV not only has deleterious effects on the child wellbeing, and cognitive and socio-emotional development, but it also negatively affects behaviors and relationships into adulthood: boys and girls who experience household violence against their mother are at increased risk of perpetuating aggressive behaviors and being victims of domestic violence later in their own lives, respectively, engaging in the so-called intergenerational perpetuation of violence.
While the WHO currently recommends screening for IPV during pregnancy, no agreement exists on the appropriateness of routine assessments of postpartum IPV.
Nevertheless, on the ground of the detrimental effects of IPV on children, the American Academy of Pediatrics advocated for IPV screening in pediatric settings, endorsing the abuse of women as a pediatric issue.
Healthcare professionals are generally in a privileged position to investigate IPV; the emergency department (ED) represents an ideal setting to detect abuse and take actions against it, providing a unique opportunity to involve the mother-child dyads in research surveys, in accordance with the international guidelines on research on violence against women and children.
The aim of this study is to assess the frequency of witnessed violence in a population of children attending a pediatric emergency department (ED) in Italy, by searching for IPV in their mother, and to define the characteristics of the mother-child dyads.
Study Type
Observational
Enrollment (Actual)
212
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Trieste, Italy, 34137
- IRCCS Burlo Garofolo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Mother-child dyads attending a pediatric Emergency Department in Italy
Description
Inclusion Criteria:
- children aged 0 to 17 years
- attending the pediatric ED (undergoing clinical observation within the ED and/or admission to the ward )
- presence of their mothers
Exclusion Criteria:
- inability of the mother to fill in the questionnaire (due to either language barrier or inability to leave the child behind for a while)
- impossibility to take the mother aside from her partner
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the prevalence of children witnessed violence
Time Frame: Within 6 hours of ED admission
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Mothers of children attending a pediatric ED will receive a questionnaire, which will include the validate italian version of Woman Abuse Screening Tool (WAST), a questionnaire assessing women's physical, psychological, and sexual abuse by their partner in the last 12 months.
It comprises eight questions, each with three possible answers, graded from 0 (never) to 2 (often): an overall score of 4 or above suggests women abuse by their partner.
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Within 6 hours of ED admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To define the demographical and clinical characteristics of the mother-child dyads enrolled
Time Frame: Within 6 hours of ED admission
|
Mothers of children attending a pediatric ED will receive a questionnaire which will include questions about their baseline data and health.
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Within 6 hours of ED admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Claudio Germani, MD, IRCCS Materno Infantile Burlo Garofolo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2020
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
March 24, 2023
First Submitted That Met QC Criteria
April 6, 2023
First Posted (Actual)
April 7, 2023
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
April 6, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC 14/19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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