Child PsychiatryFrench-CATSNCT05690113
Translation and Validation of the "Children and Adolescent Trauma Screen" in French
An observational study of Child Psychiatry and Adolescent Psychiatry, run by Hospices Civils de Lyon at 6 sites in France.
Trial summary
Child psychotraumatism and complex psychotraumatism, mainly consecutive to child maltreatment, is a major unaddressed public health issue. The investigators aim to translate and validate a screening scale to help professionals to better detect and refer children at risk of psychotraumatism. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Psychiatry, Adolescent Psychiatry
- What is being tested?
- CATS scale
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 6 sitesFrance
- Study dates
- 3 Feb 2023to 9 Mar 2024
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study will focus on children and adolescents between 7 and 17 years who have been potentially exposed to a traumatic event and who are treated in one of the participating services. This study will also focus on children and adolescents aged 7 to 17 years in the general population, enrolled in school in the Grenoble Academy.
Who may be able to join
- child aged between 7 and 17
- at least an adult of reference (parent or tutor) reachable
- agreement of adult of reference
- for clinical population : have been potentially exposed to a potential traumatic event (according to DSM-V)
Who cannot join
- non-mastery of French language
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Service de Psychopathologie de l'Enfant et l'Adolescent, Hôpital Femme Mère Enfant
Bron, 69500
Laboratoire de Psychologie et de NeuroCognition, Domaine Universitaire de Jacob Bellecombette
Chambéry, 73011
Centre Régional de Psychotraumatisme, Hôpital Edouard Herriot
Lyon, 69003
Service de Médecine Légale, Hôpital Edouard Herriot
Lyon, 69003
Centre d'Evaluation de Psychotraumatisme Pédiatrique, CHU Lenval
Nice, 06200
Centre Psychotrauma Grand Est Alsace Nord, Hôpital civil et hôpital de l'Elsau
Strasbourg, 67000
About this study
Official title: Translation and Validation in French of a Child Psychotrauma Identification Scale - the CATS (Child and Adolescent Trauma Screen)
Child psychotraumatism and complex psychotraumatism, mainly consecutive to child maltreatment, is a major unaddressed public health issue.
The investigators aim to translate and validate a screening scale to help professionals to better detect and refer children at risk of psychotraumatism.
This study aims to validate the psychometric properties of a french version of the CATS 2.0, in partnership with the original authors of the scale.
- Conditions
- Child Psychiatry, Adolescent Psychiatry
- Being tested
- CATS scale
- Keywords
- psychotraumatism, children, adolescent, scale, french translation, validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATS scaleProcedure or surgery
Also called SCARED scale, SDQ scale
During the inclusion visit (J0), enrolled children will complete the CATS scale as well as the SCARED (Screen for Child Anxiety and Related Disorders). Their parents will also complete the CATS and the SDQ (Strength and Difficulties Questionnaire).
| Study group | Role | What they receive |
|---|---|---|
| Clinical population | 250 children aged from 7 to 17 will be recruited in 6 clinical departments (child and adolescent psychiatry, forensic medicine, psychotraumatism centers) They will complete the CATS scale as well as the SCARED (Screen for Child Anxiety and Related Disorders). Their parents will also complete the CATS and the SDQ (Strength and Difficulties Questionnaire) to assess convergent and divergent validity. Receives: Procedure: CATS scale | |
| Non-clinical population | 250 children aged from 7 to 17 will be recruited in schools They will complete the CATS scale as well as the SCARED (Screen for Child Anxiety and Related Disorders). Their parents will also complete the CATS and the SDQ (Strength and Difficulties Questionnaire) to assess convergent and divergent validity. Receives: Procedure: CATS scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric properties of the Children and Adolescent Trauma Screen (CATS) scale
Construct validity (structural validity, convergent-divergent validity), intraclass correlation coefficients, and internal consistency analysis will be performed.
Measured: Day 0 (D0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start3 Feb 2023
- Primary completion9 Mar 2024
- Study completion9 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child PsychiatryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline ESPI, MD, Principal investigator, Centre Régional de Psychotraumatisme, Hôpital Edouard Herriot, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690113
- Sponsor's protocol ID
- 69HCL22_0390
- Other IDs
- 2022-A02018-35_22
- Acronym
- French-CATS
- Status last verified
- Jun 2024
- First submitted
- 29 Nov 2022
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation in French of a Child Psychotrauma Identification Scale - the CATS (Child and Adolescent Trauma Screen)
- ClinicalTrials.gov ID
- NCT05690113
- Acronym / sponsor ID
- French-CATS / 69HCL22_0390
- Conditions
- Child Psychiatry, Adolescent Psychiatry
- Keywords
- psychotraumatism, children, adolescent, scale, french translation, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 9 Mar 2024 (actual)
- Study completion
- 9 Mar 2024 (actual)
- First posted
- 19 Jan 2023 (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.
Child psychotraumatism and complex psychotraumatism, mainly consecutive to child maltreatment, is a major unaddressed public health issue.
The investigators aim to translate and validate a screening scale to help professionals to better detect and refer children at risk of psychotraumatism.
This study aims to validate the psychometric properties of a french version of the CATS 2.0, in partnership with the original authors of the scale.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical population | – | Procedure: CATS scale250 children aged from 7 to 17 will be recruited in 6 clinical departments (child and adolescent psychiatry, forensic medicine, psychotraumatism centers) They will complete the CATS scale as well as the SCARED (Screen for Child Anxiety and Related Disorders). Their parents will also complete the CATS and the SDQ (Strength and Difficulties Questionnaire) to assess convergent and divergent validity. |
| Non-clinical population | – | Procedure: CATS scale250 children aged from 7 to 17 will be recruited in schools They will complete the CATS scale as well as the SCARED (Screen for Child Anxiety and Related Disorders). Their parents will also complete the CATS and the SDQ (Strength and Difficulties Questionnaire) to assess convergent and divergent validity. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study will focus on children and adolescents between 7 and 17 years who have been potentially exposed to a traumatic event and who are treated in one of the participating services. This study will also focus on children and adolescents aged 7 to 17 years in the general population, enrolled in school in the Grenoble Academy.
Key inclusion criteria (4 listed)
- child aged between 7 and 17
- at least an adult of reference (parent or tutor) reachable
- agreement of adult of reference
- for clinical population : have been potentially exposed to a potential traumatic event (according to DSM-V)
Key exclusion criteria (1 listed)
- non-mastery of French language
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 |
|---|---|---|
| CATS scaleAlso: SCARED scale, SDQ scaleDuring the inclusion visit (J0), enrolled children will complete the CATS scale as well as the SCARED (Screen for Child Anxiety and Related Disorders). Their parents will also complete the CATS and the SDQ (Strength and Difficulties Questionnaire). | Procedure or surgery | Clinical population, Non-clinical population |
Primary outcome
Psychometric properties of the Children and Adolescent Trauma Screen (CATS) scale
Time frame: Day 0 (D0)
Construct validity (structural validity, convergent-divergent validity), intraclass correlation coefficients, and internal consistency analysis will be performed.
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 13 Jun 2024.
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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.
Pauline ESPI, MD principal investigator
Centre Régional de Psychotraumatisme, Hôpital Edouard Herriot, Hospices Civils de Lyon
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Psychiatry and Adolescent Psychiatry, run by Hospices Civils de Lyon at 6 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 4 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Psychometric properties of the Children and Adolescent Trauma Screen (CATS) scale (time frame: Day 0 (D0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2024.