Violence, DomesticNCT05803265
Children Witnessed Violence Evaluated in a Pediatric ED
An observational study of Violence, Domestic and Intimate Partner Violence, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Violence, Domestic, Intimate Partner Violence
- How many people
- 212 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 31 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Mother-child dyads attending a pediatric Emergency Department in Italy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Violence, Domestic, Intimate Partner Violence
- Keywords
- Witnessed violence, Intimate partner violence, Woman Abusive Screening Tool, Pediatric emergency department
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the prevalence of children witnessed violence
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.
Measured: Within 6 hours of ED admission
Secondary outcomes (1)
To define the demographical and clinical characteristics of the mother-child dyads enrolled
Mothers of children attending a pediatric ED will receive a questionnaire which will include questions about their baseline data and health.
Measured: Within 6 hours of ED admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start1 Feb 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Violence, DomesticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudio Germani, MD, Principal investigator, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05803265
- Sponsor's protocol ID
- RC 14/19
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Children Witnessed Violence Evaluated in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT05803265
- Acronym / sponsor ID
- RC 14/19
- Conditions
- Violence, Domestic, Intimate Partner Violence
- Keywords
- Witnessed violence, Intimate partner violence, Woman Abusive Screening Tool, Pediatric emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Mother-child dyads attending a pediatric Emergency Department in Italy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the prevalence of children witnessed violence
Time frame: Within 6 hours of ED admission
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.
1 secondary outcome
To define the demographical and clinical characteristics of the mother-child dyads enrolled
Time frame: Within 6 hours of ED admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
Related trials for Violence, Domestic
RecruitingObservational study
Self-Dehumanization and Hesitation to Report Domestic Violence
Domestic Violence
Active, not recruiting
Community Resiliency Collective Efficacy Intervention
Violence, Physical, Violence, Non-accidental
Enrolling by invitation
Evaluation of a Trauma-Informed Partner Violence Intervention Program
Domestic Violence, Post Traumatic Stress Disorder
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
RecruitingObservational study
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Germani, MD principal investigator
IRCCS materno infantile Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Violence, Domestic and Intimate Partner Violence, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the prevalence of children witnessed violence (time frame: Within 6 hours of ED admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.