AVAL: Teenagers After London Terrorist Attack

• Sponsor: University Hospital, Brest (Other)
• Overall Status: Completed
• CT.gov ID: NCT03493243
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Actual Duration (Days): 30
• Patients Per Site: 20
• Patients Per Site Per Month: 20.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Development; Post Traumatic Stress Disorder; Terrorism	Other: Questionnaires

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: AVAL Cohort Study First Step, Observational Study, After One Year
• Actual Study Start Date: Mar 14, 2018
• Actual Primary Completion Date: Apr 13, 2018
• Actual Study Completion Date: Apr 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Adolescents exposed Only clinical questionnaires	Other: Questionnaires; 2-hour clinical observation

Outcome Measures

Primary Outcome Measures

1. PTSD [One year after the terrorist attack (Day 1)]

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

Secondary Outcome Measures

1. Clinical (occurence of Post Traumatic Stress Disorders or other disorders) [One year after the terrorist attack (Day 1)]

   Mini International Neuro-psychiatric Interview for children and adolescent

2. Epidemiological (risk factors for developing disorders, avoiding care); [One year after the terrorist attack (Day 1)]

   LEC = Life Event checklist

3. Preventive and therapeutic [One year after the terrorist attack (Day 1)]

   MINI = Mini International Neuropsychiatric Interview

4. Epidemiological (risk factors for developing disorders, avoiding care); [One year after the terrorist attack (Day 1)]

   ALCES = Adolescent Life Change Event Scale

5. Epidemiological (risk factors for developing disorders, avoiding care); [One year after the terrorist attack (Day 1)]

   EPS 10 = "Echelle de Provisions Sociales Abrégées";

6. Epidemiological (risk factors for developing disorders, avoiding care); [One year after the terrorist attack (Day 1)]

   Whodas 2.0 = World Health Organization Disability Assessment Schedule

7. Preventive and therapeutic [One year after the terrorist attack (Day 1)]

   Questionnaire about use of psychoactive substances

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU	Brest		France	29200
2	HIA Hôpital d'Instruction des Armées Clermont Tonnerre	Brest		France	29200

Sponsors and Collaborators

• University Hospital, Brest

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: COULON Nathalie, medical doctor (psychiatrist for children and teenagers), principal Investigator, University Hospital, Brest
• ClinicalTrials.gov Identifier: NCT03493243
• Other Study ID Numbers: AVAL (29BRC17.0248)
• First Posted: Apr 10, 2018
• Last Update Posted: Oct 25, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by COULON Nathalie, medical doctor (psychiatrist for children and teenagers), principal Investigator, University Hospital, Brest: Adolescent; Post Traumatic Stress Disorder; Terrorist Attack
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Oct 25, 2019