Teenagers After London Terrorist Attack

Post Traumatic Stress Disorder Clinical Trial

— AVAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493243
• Other study ID #: AVAL (29BRC17.0248)
• Status: Completed
• Start date: March 14, 2018
• Est. completion date: April 13, 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Development
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Terrorism

Intervention

Other:
• Questionnaires
2-hour clinical observation

Locations

Country	Name	City	State
France	CHU	Brest
France	HIA Hôpital d'Instruction des Armées Clermont Tonnerre	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD	Post Traumatic Stress Disorder (Self-Questionnaire :Posttraumatic stress disorder checklist 5 )	One year after the terrorist attack (Day 1)
Secondary	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)
Secondary	Epidemiological (risk factors for developing disorders, avoiding care);	LEC = Life Event checklist	One year after the terrorist attack (Day 1)
Secondary	Preventive and therapeutic	MINI = Mini International Neuropsychiatric Interview	One year after the terrorist attack (Day 1)
Secondary	Epidemiological (risk factors for developing disorders, avoiding care);	ALCES = Adolescent Life Change Event Scale	One year after the terrorist attack (Day 1)
Secondary	Epidemiological (risk factors for developing disorders, avoiding care);	EPS 10 = "Echelle de Provisions Sociales Abrégées";	One year after the terrorist attack (Day 1)
Secondary	Epidemiological (risk factors for developing disorders, avoiding care);	Whodas 2.0 = World Health Organization Disability Assessment Schedule	One year after the terrorist attack (Day 1)
Secondary	Preventive and therapeutic	Questionnaire about use of psychoactive substances	One year after the terrorist attack (Day 1)