Teenagers After London Terrorist Attack (AVAL)

October 24, 2019 updated by: COULON Nathalie, University Hospital, Brest

AVAL Cohort Study First Step, Observational Study, After One Year

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Actual)

40

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

  • France
      • Brest, France, 29200
        • CHU
      • Brest, France, 29200
        • HIA Hôpital d'Instruction des Armées Clermont Tonnerre

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

14 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adolescents exposed
Only clinical questionnaires
Other: Questionnaires
2-hour clinical observation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical (occurence of Post Traumatic Stress Disorders or other disorders)
Time Frame: One year after the terrorist attack (Day 1)
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);
Time Frame: One year after the terrorist attack (Day 1)
LEC = Life Event checklist
One year after the terrorist attack (Day 1)
Preventive and therapeutic
Time Frame: One year after the terrorist attack (Day 1)
MINI = Mini International Neuropsychiatric Interview
One year after the terrorist attack (Day 1)
Epidemiological (risk factors for developing disorders, avoiding care);
Time Frame: One year after the terrorist attack (Day 1)
ALCES = Adolescent Life Change Event Scale
One year after the terrorist attack (Day 1)
Epidemiological (risk factors for developing disorders, avoiding care);
Time Frame: One year after the terrorist attack (Day 1)
EPS 10 = "Echelle de Provisions Sociales Abrégées";
One year after the terrorist attack (Day 1)
Epidemiological (risk factors for developing disorders, avoiding care);
Time Frame: One year after the terrorist attack (Day 1)
Whodas 2.0 = World Health Organization Disability Assessment Schedule
One year after the terrorist attack (Day 1)
Preventive and therapeutic
Time Frame: One year after the terrorist attack (Day 1)
Questionnaire about use of psychoactive substances
One year after the terrorist attack (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Nathalie V COULON, MD PhD, CHU Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 14, 2018

Primary Completion (Actual)

April 13, 2018

Study Completion (Actual)

April 13, 2018

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVAL (29BRC17.0248)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Secured email aval.france@chu-brest.fr

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

aval.france@chu-brest.fr/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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