CompletedNCT03493243AVALUpdated Oct 25, 2019

Teenagers After London Terrorist Attack

An observational study in Adolescent Development, Post Traumatic Stress Disorder and Terrorism, sponsored by University Hospital, Brest. Completed at 2 sites in France. Open to participants aged 14 Years to 20 Years. Per ClinicalTrials.gov, last updated 2019-10-25.

Sponsored by University Hospital, Brest · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 40
Ages: 14 Years to 20 Years
Sex: All

Study 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.

Read the 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)

Conditions studied

Adolescent Development
Post Traumatic Stress Disorder
Terrorism

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Keywords

Adolescent
Post Traumatic Stress Disorder
Terrorist Attack

Who can participate

Ages eligible: 14 Years to 20 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 40 participants (actual)
Target follow-up: 2 Weeks
Patient registry: Yes

Groups and cohorts

Adolescents exposed
Only clinical questionnaires
Other: Questionnaires

Interventions

OtherQuestionnaires
2-hour clinical observation

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

2 sites

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

References and documents

Publications

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. PubMed 31708812 ↗

Individual participant data

Plan to share: Yes — Secured email aval.france@chu-brest.fr

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

Registry details

Key details

Study ID: NCT03493243
Lead sponsor: University Hospital, Brest
Responsible party: COULON Nathalie (medical doctor (psychiatrist for children and teenagers), principal Investigator, University Hospital, Brest) — Principal investigator
First posted: Apr 10, 2018
Start date: Mar 14, 2018
Primary completion: Apr 13, 2018
Completion: Apr 13, 2018
Last update: Oct 25, 2019

Study contacts

Nathalie V COULON, MD PhD

study director · CHU Brest

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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