Complex Post-Traumatic Stress Disorder (CPTSD)PePsAdoTNDNCT07794332
Symptom Assessment in Adolescents Placed on Child Welfare
An observational study of Complex Post-Traumatic Stress Disorder (CPTSD) and Borderline Personality Disorder (BPD), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This study aims to characterize emotional dysregulation in complex post-traumatic stress disorder (cPTSD) and to determine the extent to which it can promote the distinction with borderline personality disorder (BPD) and post-traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder (CPTSD), Borderline Personality Disorder (BPD), Post-Traumatic Stress Disorder, PTSD
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2026to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: a population of adolescents recently placed at the Bas-Rhin ASE
Who may be able to join
- Adolescent aged 12 to 17
- Entrusted to ASE Bas-Rhin.
- Fluent in French
- Affiliated with a social health insurance scheme
- Agreeing to take part in the study
- Legal representative of the minor or his/her guardian, or his/her representative from the ASE agreeing to take part in the study.
Who cannot join
- Adolescent refusing to participate in the study
- Legal representative of the minor or his/her guardian, or his/her ASE representative refusing to participate in the study
- Adolescent with severe developmental delay
- Adolescent participating in another research study
- Adolescent deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, Grand Est, 67000
Carmen SCHRÖDER, 0033388115248, carmen.schroder@chru-strasbourg.fr
About this study
Official title: Evaluation of Post-traumatic and Neurodevelopmental Symptoms in Adolescents Placed in Child Welfare
This study aims to characterize emotional dysregulation in complex post-traumatic stress disorder (cPTSD) and to determine the extent to which it can promote the distinction with borderline personality disorder (BPD) and post-traumatic stress disorder (PTSD).
As emotional dysregulation is a dynamic process whose phenomenological manifestations are labile, associated with physiological modifications and modulated by cognitive processing, a multiple methodology associating measurements in a real-life ecological context with measurements performed in the hospital will be preferred.
Overall, this study proposes to capture, for the first time, the clinical manifestations associated with cPTSD from the perspective of emotional dysregulation and its underlying processes
- Conditions
- Complex Post-Traumatic Stress Disorder (CPTSD), Borderline Personality Disorder (BPD), Post-Traumatic Stress Disorder, PTSD
- Medical subject headings
- Borderline Personality Disorder, Combat Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of post-traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
PTSD will be assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria, using the Child Post-Traumatic Checklist (CPC-P). The outcome will be the proportion of participants meeting DSM-5 diagnostic criteria for PTSD.
Measured: From inclusion to the end (6 months)
Prevalence of complex post-traumatic stress disorder (CPTSD) according to International Classification of Diseases, 11th Revision (ICD-11) criteria
Complex post-traumatic stress disorder (CPTSD) will be assessed according to the International Classification of Diseases, 11th Revision (ICD-11) diagnostic criteria, using the Child and Adolescent Trauma Screen (CATS). The outcome will be the proportion of participants meeting ICD-11 diagnostic criteria for CPTSD.
Measured: From inclusion to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Jan 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic Stress Disorder (CPTSD)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794332
- Sponsor's protocol ID
- 9483
- Other IDs
- 2024-A02448-39
- Acronym
- PePsAdoTND
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 31 Aug 2026
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-traumatic and Neurodevelopmental Symptoms in Adolescents Placed in Child Welfare
- ClinicalTrials.gov ID
- NCT07794332
- Acronym / sponsor ID
- PePsAdoTND / 9483
- Conditions
- Complex Post-Traumatic Stress Disorder (CPTSD), Borderline Personality Disorder (BPD), Post-Traumatic Stress Disorder, PTSD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 31 Aug 2026 (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.
This study aims to characterize emotional dysregulation in complex post-traumatic stress disorder (cPTSD) and to determine the extent to which it can promote the distinction with borderline personality disorder (BPD) and post-traumatic stress disorder (PTSD).
As emotional dysregulation is a dynamic process whose phenomenological manifestations are labile, associated with physiological modifications and modulated by cognitive processing, a multiple methodology associating measurements in a real-life ecological context with measurements performed in the hospital will be preferred.
Overall, this study proposes to capture, for the first time, the clinical manifestations associated with cPTSD from the perspective of emotional dysregulation and its underlying processes
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- a population of adolescents recently placed at the Bas-Rhin ASE
Key inclusion criteria (6 listed)
- Adolescent aged 12 to 17
- Entrusted to ASE Bas-Rhin.
- Fluent in French
- Affiliated with a social health insurance scheme
- Agreeing to take part in the study
Key exclusion criteria (5 listed)
- Adolescent refusing to participate in the study
- Legal representative of the minor or his/her guardian, or his/her ASE representative refusing to participate in the study
- Adolescent with severe developmental delay
- Adolescent participating in another research study
- Adolescent deprived of liberty by judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of post-traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
Time frame: From inclusion to the end (6 months)
PTSD will be assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria, using the Child Post-Traumatic Checklist (CPC-P). The outcome will be the proportion of participants meeting DSM-5 diagnostic criteria for PTSD.
Prevalence of complex post-traumatic stress disorder (CPTSD) according to International Classification of Diseases, 11th Revision (ICD-11) criteria
Time frame: From inclusion to 6 months
Complex post-traumatic stress disorder (CPTSD) will be assessed according to the International Classification of Diseases, 11th Revision (ICD-11) diagnostic criteria, using the Child and Adolescent Trauma Screen (CATS). The outcome will be the proportion of participants meeting ICD-11 diagnostic criteria for CPTSD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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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.
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 Complex Post-Traumatic Stress Disorder (CPTSD) and Borderline Personality Disorder (BPD), run by University Hospital, Strasbourg, France 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen SCHRÖDER (0033388115248, carmen.schroder@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of post-traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (time frame: From inclusion to the end (6 months)). The study lists 2 primary outcomes in all. 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 31 Aug 2026.