Teenagers After London Terrorist Attack | NCT03493243

Studies
Teenagers After London Terrorist Attack

NCT03493243

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Oct 25, 2019Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Adolescent Development
Post Traumatic Stress Disorder
Terrorism

Interventions

Questionnaires

Countries

France

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

Oct 2019

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

Mar 14, 2018Actual

Primary Completion Date

Apr 13, 2018Actual

Completion Date

Apr 13, 2018Actual

First Submitted Date

Mar 20, 2018

First Submission Date that Met QC Criteria

Apr 9, 2018

First Posted Date

Apr 10, 2018Actual

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

Oct 24, 2019

Last Update Posted Date

Oct 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

COULON Nathalie, medical doctor (psychiatrist for children and teenagers), principal Investigator, University Hospital, BrestPrincipal Investigator

Lead Sponsor

University Hospital, BrestOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Context: Since March 2012, several terrorist attacks have been perpetrated in France (Toulouse, Montauban, Paris, Nice ...). In March 2017, 53 french teenagers were victims in a terrorist attack in London (Westminster Bridge).
Main goal = to estimate the psycho-traumatic impact and to describe cares and management of high school students, victims of the terrorist attack in London on 2017, March the 22nd.
3 secondary objectives: 1) Clinical (occurrence of Post Traumatic Stress Disorders or other disorders); 2) Epidemiological (risk factors for developing disorders, avoiding care); 3) Preventive and therapeutic.

Detailed Description

Inclusion criterion: 53 teenagers of Saint-Joseph high school (Concarneau, France) directly exposed to the terrorist attack.

Methodology: self questionnaires and heterogenous questionnaires; descriptive statistics (means +/- standard deviations; search for a significant difference according to traumatic symptomatology)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adolescents exposed		Only clinical questionnaires	Other: Questionnaires

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Other	2-hour clinical observation	Adolescents exposed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PTSD	Post Traumatic Stress Disorder (Self-Questionnaire :Posttraumatic stress disorder checklist 5 )	One year after the terrorist attack (Day 1)

Secondary Outcomes

Measure	Description	Time Frame
Clinical (occurence of Post Traumatic Stress Disorders or other disorders)	Mini International Neuro-psychiatric Interview for children and adolescent	One year after the terrorist attack (Day 1)
Epidemiological (risk factors for developing disorders, avoiding care);

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

53 teenagers, from Concarneau (France) high school, directly exposed from London terrorist attack (22.03.2017).

Exclusion Criteria:

All persons not directly exposed;
Relatives of teenagers;
3 physically injured teenagers.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

53 Teenagers;
Saint-Joseph high school (29)
Directly exposed.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nathalie V COULON, MD PhD	CHU Brest	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU		Brest		29200	France
HIA Hôpital d'Instruction des Armées Clermont Tonnerre

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31708812	Derived	Grenon M, Consigny M, Lemey C, Simson JP, Coulon N. Impact of a Terrorist Attack on the Mental Health of Directly Exposed French Adolescents: Study Protocol for the First Step of the AVAL Cohort Study. Front Psychiatry. 2019 Oct 25;10:744. doi: 10.3389/fpsyt.2019.00744. eCollection 2019.

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms