Adolescent DevelopmentAVALNCT03493243
Teenagers After London Terrorist Attack
An observational study of Adolescent Development and Post Traumatic Stress Disorder, run by University Hospital, Brest at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Adolescent Development, Post Traumatic Stress Disorder, Terrorism
- What is being tested?
- Questionnaires
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Mar 2018to 13 Apr 2018
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: * 53 Teenagers; * Saint-Joseph high school (29) * Directly exposed.
Who may be able to join
- 53 teenagers, from Concarneau (France) high school, directly exposed from London terrorist attack (22.03.2017).
Who cannot join
- All persons not directly exposed;
- Relatives of teenagers;
- 3 physically injured teenagers.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU
Brest, 29200
HIA Hôpital d'Instruction des Armées Clermont Tonnerre
Brest, 29200
About this study
Official title: 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.
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)
- Being tested
- Questionnaires
- Keywords
- Adolescent, Post Traumatic Stress Disorder, Terrorist Attack
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
2-hour clinical observation
| Study group | Role | What they receive |
|---|---|---|
| Adolescents exposed | Only clinical questionnaires Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
Post Traumatic Stress Disorder (Self-Questionnaire :Posttraumatic stress disorder checklist 5 )
Measured: One year after the terrorist attack (Day 1)
Secondary outcomes (7)
Clinical (occurence of Post Traumatic Stress Disorders or other disorders)
Mini International Neuro-psychiatric Interview for children and adolescent
Measured: One year after the terrorist attack (Day 1)
Epidemiological (risk factors for developing disorders, avoiding care);
LEC = Life Event checklist
Measured: One year after the terrorist attack (Day 1)
Preventive and therapeutic
MINI = Mini International Neuropsychiatric Interview
Measured: One year after the terrorist attack (Day 1)
Epidemiological (risk factors for developing disorders, avoiding care);
ALCES = Adolescent Life Change Event Scale
Measured: One year after the terrorist attack (Day 1)
Epidemiological (risk factors for developing disorders, avoiding care);
EPS 10 = "Echelle de Provisions Sociales Abrégées";
Measured: 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
Measured: One year after the terrorist attack (Day 1)
Preventive and therapeutic
Questionnaire about use of psychoactive substances
Measured: One year after the terrorist attack (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start14 Mar 2018
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, COULON Nathalie, University Hospital, Brest
- Investigators
- Nathalie V COULON, MD PhD, Study director, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493243
- Sponsor's protocol ID
- AVAL (29BRC17.0248)
- Acronym
- AVAL
- Status last verified
- Oct 2019
- First submitted
- 20 Mar 2018
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Secured email aval.france@chu-brest.fr
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVAL Cohort Study First Step, Observational Study, After One Year
- ClinicalTrials.gov ID
- NCT03493243
- Acronym / sponsor ID
- AVAL / AVAL (29BRC17.0248)
- Keywords
- Adolescent, Post Traumatic Stress Disorder, Terrorist Attack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents exposed | – | Other: QuestionnairesOnly clinical questionnaires |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- * 53 Teenagers; * Saint-Joseph high school (29) * Directly exposed.
Key inclusion criteria (1 listed)
- 53 teenagers, from Concarneau (France) high school, directly exposed from London terrorist attack (22.03.2017).
Key exclusion criteria (3 listed)
- All persons not directly exposed;
- Relatives of teenagers;
- 3 physically injured teenagers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires2-hour clinical observation | Other | Adolescents exposed |
Primary outcome
PTSD
Time frame: One year after the terrorist attack (Day 1)
Post Traumatic Stress Disorder (Self-Questionnaire :Posttraumatic stress disorder checklist 5 )
7 secondary outcomes
Clinical (occurence of Post Traumatic Stress Disorders or other disorders)
Time frame: 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)
Preventive and therapeutic
Time frame: 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)
Epidemiological (risk factors for developing disorders, avoiding care);
Time frame: 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)
Preventive and therapeutic
Time frame: One year after the terrorist attack (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Derived from this study: PubMed 31708812Grenon 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.
- Individual participant dataSharing planned: Yes. Secured email aval.france@chu-brest.fr
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie V COULON, MD PhD study director
CHU Brest
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Development and Post Traumatic Stress Disorder, run by University Hospital, Brest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD (time frame: One year after the terrorist attack (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03493243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.