Psychological TraumaALEXNCT04850924
Emergency Psychological Intervention With Children: Alex Storm
An observational study of Psychological Trauma, run by Fondation Lenval at 1 site in France.
Trial summary
Alex storm hits France, especially the French Riviera, from September 30, 2020 to October 3, 2020. A lot of people have been impacted by this event. Among these people, 116 children have been taking care by the medico-psychological emergency unit and have been assessed by child psychiatrists or by psychologists. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Trauma
- What is being tested?
- evaluation psychological trauma
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2021to 26 Feb 2021
- 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 Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children aged between 0 to 18 years. Impacted by the Alex Storm and evacuated to Nice airport
Who may be able to join
- children impacted by the Alex storm
- children seen in an emergency between October 3 and October 30, 2020
- children were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma
Who cannot join
- children whose parents refused to the processing of their data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alex Storm: Acute Stress Manifestations' Description in French Pediatric Population
Alex storm hits France, especially the French Riviera, from September 30, 2020 to October 3, 2020. A lot of people have been impacted by this event. Among these people, 116 children have been taking care by the medico-psychological emergency unit and have been assessed by child psychiatrists or by psychologists.
Read the detailed description
Alex storm hits France from September 30, 2020 to October 3, 2020. On October 2, several valley in the Nice hinterland were devastated by this natural disaster. Nine people died during this storm and hundreds of families were affected (house washed away or uninhabitable). This led to emergency evacuations on October 3 of several families. The inhabitants of some villages have been subjected to prolonged stress (lack of water and electricity, difficulty in supplying food, fear of another storm). These villages were isolated for a period varying from fifteen days to over three months. These people are particularly exposed to psychological consequences.
Between October 3 and October 30, the CUMP (medico-psychological emergency unit) was mobilized to provide psychological first aid to these families. Among those seen in emergency 116 children were taken care of. In order to assess the immediate symptoms of the children, the investigators used an assessment sheet specific to the developmental ages of the children.
All children seen in an emergency between October 3 and October 30, 2020 were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma.
- Conditions
- Psychological Trauma
- Being tested
- evaluation psychological trauma
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation psychological traumaOther
9 classes of symptoms to be evaluated
| Study group | Role | What they receive |
|---|---|---|
| children impact by the Alex storm | Not described Receives: Other: evaluation psychological trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of risk developing post-traumatic stress disorder
A questionnaire assessing symptoms in the acute phase. 9 classes of symptoms to be evaluated..
Anxiety - Sadness / Cries - Mutism / Apartness - Passiveness - Agitation / Panic / Disorganization - Somatization - Developmental regression / Excessive attachment to caregiver - Verbalization of fear - Sleep disorders All symptoms are assessed by scoring presence (1) or absence (0). The total score is calculated out of 9 and refers to the risk of later developing post-traumatic stress disorder (PTSD) (0 = very low risk; 9 = very high risk)
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start18 Jan 2021
- Primary completion26 Feb 2021
- Study completion26 Feb 2021
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 Psychological TraumaStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850924
- Sponsor's protocol ID
- 21-HPNCL-01
- Acronym
- ALEX
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Richez A, Gindt M, Battista M, Nachon O, Menard ML, Askenazy F, Fernandez A, Thummler S. Storm Alex: acute stress responses in the pediatric population. Eur J Psychotraumatol. 2022 May 11;13(1):2067297. doi: 10.1080/20008198.2022.2067297. eCollection 2022.
PubMed 35599977
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alex Storm: Acute Stress Manifestations' Description in French Pediatric Population
- ClinicalTrials.gov ID
- NCT04850924
- Acronym / sponsor ID
- ALEX / 21-HPNCL-01
- Conditions
- Psychological Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 20 Apr 2021 (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.
Alex storm hits France, especially the French Riviera, from September 30, 2020 to October 3, 2020. A lot of people have been impacted by this event. Among these people, 116 children have been taking care by the medico-psychological emergency unit and have been assessed by child psychiatrists or by psychologists.
Detailed description
Alex storm hits France from September 30, 2020 to October 3, 2020. On October 2, several valley in the Nice hinterland were devastated by this natural disaster. Nine people died during this storm and hundreds of families were affected (house washed away or uninhabitable). This led to emergency evacuations on October 3 of several families. The inhabitants of some villages have been subjected to prolonged stress (lack of water and electricity, difficulty in supplying food, fear of another storm). These villages were isolated for a period varying from fifteen days to over three months. These people are particularly exposed to psychological consequences.
Between October 3 and October 30, the CUMP (medico-psychological emergency unit) was mobilized to provide psychological first aid to these families. Among those seen in emergency 116 children were taken care of. In order to assess the immediate symptoms of the children, the investigators used an assessment sheet specific to the developmental ages of the children.
All children seen in an emergency between October 3 and October 30, 2020 were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children impact by the Alex storm | – | Other: evaluation psychological trauma |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children aged between 0 to 18 years. Impacted by the Alex Storm and evacuated to Nice airport
Key inclusion criteria (3 listed)
- children impacted by the Alex storm
- children seen in an emergency between October 3 and October 30, 2020
- children were assessed by child psychiatrists or by psychologists trained in emergency and pediatric psychological trauma
Key exclusion criteria (1 listed)
- children whose parents refused to the processing of their data
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 |
|---|---|---|
| evaluation psychological trauma9 classes of symptoms to be evaluated | Other | children impact by the Alex storm |
Primary outcome
measure of risk developing post-traumatic stress disorder
Time frame: at inclusion
A questionnaire assessing symptoms in the acute phase. 9 classes of symptoms to be evaluated.. Anxiety - Sadness / Cries - Mutism / Apartness - Passiveness - Agitation / Panic / Disorganization - Somatization - Developmental regression / Excessive attachment to caregiver - Verbalization of fear - Sleep disorders All symptoms are assessed by scoring presence (1) or absence (0). The total score is calculated out of 9 and refers to the risk of later developing post-traumatic stress disorder (PTSD) (0 = very low risk; 9 = very high risk)
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 20 Apr 2021.
- Derived from this study: PubMed 35599977Richez A, Gindt M, Battista M, Nachon O, Menard ML, Askenazy F, Fernandez A, Thummler S. Storm Alex: acute stress responses in the pediatric population. Eur J Psychotraumatol. 2022 May 11;13(1):2067297. doi: 10.1080/20008198.2022.2067297. eCollection 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Trauma, run by Fondation Lenval at 1 site 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 3 inclusion and 1 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
measure of risk developing post-traumatic stress disorder (time frame: at inclusion). 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 NCT04850924, 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 20 Apr 2021.