NCT03493243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2018

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

1 month

First QC Date

March 20, 2018

Last Update Submit

October 24, 2019

Conditions

Adolescent DevelopmentPost Traumatic Stress DisorderTerrorism

Keywords

AdolescentPost Traumatic Stress DisorderTerrorist Attack

Outcome Measures

Primary Outcomes (1)

  • PTSD

    Post Traumatic Stress Disorder (Self-Questionnaire :Posttraumatic stress disorder checklist 5 )

    One year after the terrorist attack (Day 1)

Secondary Outcomes (7)

  • Clinical (occurence of Post Traumatic Stress Disorders or other disorders)

    One year after the terrorist attack (Day 1)

  • Epidemiological (risk factors for developing disorders, avoiding care);

    One year after the terrorist attack (Day 1)

  • Preventive and therapeutic

    One year after the terrorist attack (Day 1)

  • Epidemiological (risk factors for developing disorders, avoiding care);

    One year after the terrorist attack (Day 1)

  • Epidemiological (risk factors for developing disorders, avoiding care);

    One year after the terrorist attack (Day 1)

  • +2 more secondary outcomes

Study Arms (1)

Adolescents exposed

Only clinical questionnaires

Other: Questionnaires

Interventions

QuestionnairesOTHER

2-hour clinical observation

Adolescents exposed

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU

Brest, 29200, France

Location

HIA Hôpital d'Instruction des Armées Clermont Tonnerre

Brest, 29200, France

Location

Related Publications (1)

  • 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.

    PMID: 31708812DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Nathalie V COULON, MD PhD

    CHU Brest

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor (psychiatrist for children and teenagers), principal Investigator

Study Record Dates

First Submitted

March 20, 2018

First Posted

April 10, 2018

Study Start

March 14, 2018

Primary Completion

April 13, 2018

Study Completion

April 13, 2018

Last Updated

October 25, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

Secured email aval.france@chu-brest.fr

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 months
Access Criteria
aval.france@chu-brest.fr/

Locations

FR(2)