Assessment of Bullying in Children | NCT01439763

Studies
Assessment of Bullying in Children

NCT01439763

Sponsor

New York City Health and Hospitals Corporation

Status

Completed

Last Update Posted

Nov 27, 2020Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Problematic Behavior in Children

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011Actual

Primary Completion Date

Nov 15, 2020Actual

Completion Date

Nov 15, 2020Actual

First Submitted Date

Sep 21, 2011

First Submission Date that Met QC Criteria

Sep 22, 2011

First Posted Date

Sep 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2020

Last Update Posted Date

Nov 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Muhammad Waseem, Research Director, Emergency Medicine, New York City Health and Hospitals CorporationPrincipal Investigator

Lead Sponsor

New York City Health and Hospitals CorporationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The specific aims of this study are:

To determine the prevalence of bullying in children who present to the ED with behavioral symptoms
To assess mental health diagnoses and their relationship to type, severity and frequency of bullying behaviors, as well as demographic and psychosocial correlates (socioeconomic status, stress and support) and their relationship to type, severity and frequency of bullying (bullies versus victims).
To explore the attitudes, values, triggering events and potential solutions using qualitative methods
To gain greater insight into the patient experience and perceptions of the bullying events

Detailed Description

This is a mix method study which has both qualitative and quantitative components.

Data Collection sheet
Qualitative Measurement
Quantitative Measurement
Data Collection sheet
1. Demographic information (Date of birth, gender, race/ethnicity)
2. Assessment of socioeconomic status (Type of Insurance, Zip Code, Parent education level, Parent type of work)
3. Child physical attributes (Appearance, Weight, Height, Percentiles & BMI, Assisted Devices, Disabilities)
4. Academic performance (Whether grades are age appropriate, previous grade results
5. Extra-curricular activities (Questions include do you participate in sports? Are you member of any sport team? Are you member of any club?)

Qualitative Measurement

In order to understand bullying and victimization, a brief qualitative interview will be conducted by the principal investigator and his team. These questions may provide insights into the dynamics of bullying.

Quantitative Measurement

Following measurement scales will be used in the assessment of children with bullying Bullying → Olweus Bullying Questionnaire Child behavior → Achenbach Child Behavior Checklist Stress, life events and adversities → Adolescent Perceived Events Scale (APES) Social support → Child and Adolescent Social Support Scale (Malecki 2000) Social status → MacArthur Scale of Subjective Social Status Family Structure → A documentation of family structure and dynamics Mental health status → Psychiatric evaluation

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bullying	Bullying incidents	last one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with psychiatric or behavioral problem(s) age 8-18 years referred from the school to the ED
Parents willing to provide informed consent and child providing assent

Exclusion Criteria:

Actively violent behavior
Child abuse
Parents or children refuse to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children 8-18 years of age referred from school to the Emergency Department due to Behavior Problems

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muhammad Waseem, MD	Lincoln Medical & Mental Health Center, Bronx New York	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lincoln Medical & Mental Health Center		The Bronx	New York	10451	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11311098	Background	Nansel TR, Overpeck M, Pilla RS, Ruan WJ, Simons-Morton B, Scheidt P. Bullying behaviors among US youth: prevalence and association with psychosocial adjustment. JAMA. 2001 Apr 25;285(16):2094-100. doi: 10.1001/jama.285.16.2094.
19171624	Background	Analitis F, Velderman MK, Ravens-Sieberer U, Detmar S, Erhart M, Herdman M, Berra S, Alonso J, Rajmil L; European Kidscreen Group. Being bullied: associated factors in children and adolescents 8 to 18 years old in 11 European countries. Pediatrics. 2009 Feb;123(2):569-77. doi: 10.1542/peds.2008-0323.

ID	Term
D000374	Aggression
D001526	Behavioral Symptoms
D001519	Behavior
D000071277	Harassment, Non-Sexual