Post-traumatic Stress DisorderTRAUMADOPSYNCT06138522
Qualitative Study on the Perception of Changes in the Psychotherapy of Traumatized Young People
An observational study of Post-traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The clinic of psychological trauma in adolescents still requires further development, whereas it is well documented in adults. This clinic is complex, because it must take into account the nature and type of trauma (recent or not, intentional or not, situations of abuse or sexual violence, etc.), the impact on… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Semi-structured interviews, Child Post-Traumatic Stress Response Index (CPTS-RI) scale and - Therapeutic Alliance Questionnaire (HAQ-CP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2023to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adolescents suffering from psychotrauma and psychotherapy follow-up in the Consultation Service, Maison de Solenn, Maison des adolescents de l'hôpital Cochin (AP-HP).
Who may be able to join
- Teenagers :
- Teenagers from 12 to 18 years old
- Post-traumatic stress disorder (DSM Criteria 5 Post-Traumatic Stress Disorder)
- Consultant at the Maison de Solenn (Maison des Adolescents)
- Affiliated to a social security scheme
- Parents : parents of adolescents followed at the MDA and agreeing to participate in the study
- Professionals: providing psychotherapeutic follow-up for adolescents at the MDa
Who cannot join
- Refusal of the adolescent and/or his/her family (if applicable) to participate in the study,
- Adults (all groups combined): under guardianship or curatorship, under judicial protection
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
University Hospital Cochin, Maison des Adolescents - Youth Department, F-75014 Paris, France
Paris, IDF, 75014
Sevan Minassian, 00 33 1 58 41 24 29, sevan.minassian@aphp.fr
Khadija Chahraoui
About this study
The clinic of psychological trauma in adolescents still requires further development, whereas it is well documented in adults. This clinic is complex, because it must take into account the nature and type of trauma (recent or not, intentional or not, situations of abuse or sexual violence, etc.), the impact on development, the contexts (social, cultural and family) in which the trauma occurs, and the various vulnerability factors associated with it. This complexity has implications for psychotherapeutic management, which needs to be tailored to the specific clinical profiles of adolescents.
Several studies have evaluated psychotherapy for traumatized adolescents, showing a positive short-term effect on the reduction of post-traumatic stress symptoms, whatever the type of psychotherapy. Few studies, however, have analyzed the therapeutic process and the common factors of change, linked mainly to the therapeutic alliance, the patient's experience and the therapist's role: key factors of change according to the international literature. In this context, the patient's experience of his or her psychotherapeutic follow-up is a source of information that has long been neglected, even though it seems essential for better investigating and understanding the complexity of the processes at play in trauma psychotherapy.
Read the detailed description
The clinic of psychological trauma in adolescents still requires further development, whereas it is well documented in adults. This clinic is complex, because it must take into account the nature and type of trauma (recent or not, intentional or not, situations of abuse or sexual violence, etc.), the impact on development, the contexts (social, cultural and family) in which the trauma occurs, and the various vulnerability factors associated with it. This complexity has implications for psychotherapeutic management, which needs to be tailored to the specific clinical profiles of adolescents.
Several studies have evaluated psychotherapy for traumatized adolescents, showing a positive short-term effect on the reduction of post-traumatic stress symptoms, whatever the type of psychotherapy. Few studies, however, have analyzed the therapeutic process and the common factors of change, linked mainly to the therapeutic alliance, the patient's experience and the therapist's role: key factors of change according to the international literature. In this context, the patient's experience of his or her psychotherapeutic follow-up is a source of information that has long been neglected, even though it seems essential for better investigating and understanding the complexity of the processes at play in trauma psychotherapy.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Semi-structured interviews, Child Post-Traumatic Stress Response Index (CPTS-RI) scale, - Therapeutic Alliance Questionnaire (HAQ-CP)
- Keywords
- Post-traumatic stress disorder, Psychotherapy, Qualitative study
- 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.
Semi-structured interviewsBehavioural
Semi-structured interviews
Child Post-Traumatic Stress Response Index (CPTS-RI) scaleBehavioural
Child Post-Traumatic Stress Response Index (CPTS-RI) scale
- Therapeutic Alliance Questionnaire (HAQ-CP)Behavioural
- Therapeutic Alliance Questionnaire (HAQ-CP)
| Study group | Role | What they receive |
|---|---|---|
| Adolescents | Participants in consultations specialising in the treatment of psychotrauma at the Maison de Solenn Receives: Behavioral: Semi-structured interviews; Behavioral: Child Post-Traumatic Stress Response Index (CPTS-RI) scale; Behavioral: - Therapeutic Alliance Questionnaire (HAQ-CP) | |
| Parents | Participants in consultations specialising in the treatment of psychotrauma at the Maison de Solenn Receives: Behavioral: Semi-structured interviews; Behavioral: - Therapeutic Alliance Questionnaire (HAQ-CP) | |
| Professionals | Participants in consultations specialising in the treatment of psychotrauma at the Maison de Solenn Receives: Behavioral: - Therapeutic Alliance Questionnaire (HAQ-CP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semi-structured interviews
Adolescent Psychotherapy Experience = Evolution in semi-structured interviews at the beginning (T1) and end (T2) of psychotherapy (adolescents)
Measured: At the end of the psychotherapy (up to month 12)
Secondary outcomes (3)
Child Post-Traumatic Stress Response Index (CPTS-RI) scale
Evolution of psychotraumatic symptoms in adolescents (CPTS-IR) between the beginning (T1) and the end of psychotherapy (T2) (adolescents).
The Child Posttraumatic Stress Reaction Index (CPTS-RI) measures the presence of post-traumatic stress disorder:
Severity is generally assessed according to the following criteria:
0 - 11: mild, 11 - 24: mild, 25 - 39: moderate, 40 - 59: severe, 60 - 80: very severe.
Measured: At the end of the psychotherapy (up to month 12)
Therapeutic Alliance Questionnaire (HAQ-CP)
Perception of change, the therapeutic alliance perceived by adolescents, parents and therapists at the end of psychotherapy (adolescents + parents + professionals).
The Helping Alliance Questionnaires for Child and Parents (HAQ-CP) assesses the quality of the therapeutic alliance.
Answers to the questionnaires produce 2 scores:
An alliance score ranging from 0 (weak alliance) to 100 (strong alliance) A well-being score ranging from 0 (feeling unwell) to 10 (feeling well).
Measured: At the end of the psychotherapy (up to month 12)
Semi-structured interviews
Experience at the end (T2) of psychotherapy (parents)
Measured: At the end of the psychotherapy (up to month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start30 Nov 2023
- Primary completionMay 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Sevan Minassian, MD, Principal investigator, University Hospital Cochin, Maison des Adolescents - Youth Department, F-75014 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138522
- Sponsor's protocol ID
- APHP231046
- Other IDs
- 2023-A01689-36
- Acronym
- TRAUMADOPSY
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2023
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Study on the Perception of Changes in the Psychotherapy of Traumatized Young People
- ClinicalTrials.gov ID
- NCT06138522
- Acronym / sponsor ID
- TRAUMADOPSY / APHP231046
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Post-traumatic stress disorder, Psychotherapy, Qualitative study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Nov 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.
The clinic of psychological trauma in adolescents still requires further development, whereas it is well documented in adults. This clinic is complex, because it must take into account the nature and type of trauma (recent or not, intentional or not, situations of abuse or sexual violence, etc.), the impact on development, the contexts (social, cultural and family) in which the trauma occurs, and the various vulnerability factors associated with it. This complexity has implications for psychotherapeutic management, which needs to be tailored to the specific clinical profiles of adolescents.
Several studies have evaluated psychotherapy for traumatized adolescents, showing a positive short-term effect on the reduction of post-traumatic stress symptoms, whatever the type of psychotherapy. Few studies, however, have analyzed the therapeutic process and the common factors of change, linked mainly to the therapeutic alliance, the patient's experience and the therapist's role: key factors of change according to the international literature. In this context, the patient's experience of his or her psychotherapeutic follow-up is a source of information that has long been neglected, even though it seems essential for better investigating and understanding the complexity of the processes at play in trauma psychotherapy.
Detailed description
The clinic of psychological trauma in adolescents still requires further development, whereas it is well documented in adults. This clinic is complex, because it must take into account the nature and type of trauma (recent or not, intentional or not, situations of abuse or sexual violence, etc.), the impact on development, the contexts (social, cultural and family) in which the trauma occurs, and the various vulnerability factors associated with it. This complexity has implications for psychotherapeutic management, which needs to be tailored to the specific clinical profiles of adolescents.
Several studies have evaluated psychotherapy for traumatized adolescents, showing a positive short-term effect on the reduction of post-traumatic stress symptoms, whatever the type of psychotherapy. Few studies, however, have analyzed the therapeutic process and the common factors of change, linked mainly to the therapeutic alliance, the patient's experience and the therapist's role: key factors of change according to the international literature. In this context, the patient's experience of his or her psychotherapeutic follow-up is a source of information that has long been neglected, even though it seems essential for better investigating and understanding the complexity of the processes at play in trauma psychotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adolescents | – | Behavioral: Semi-structured interviews, Behavioral: Child Post-Traumatic Stress Response Index (CPTS-RI) scale, Behavioral: - Therapeutic Alliance Questionnaire (HAQ-CP)Participants in consultations specialising in the treatment of psychotrauma at the Maison de Solenn |
| Parents | – | Behavioral: Semi-structured interviews, Behavioral: - Therapeutic Alliance Questionnaire (HAQ-CP)Participants in consultations specialising in the treatment of psychotrauma at the Maison de Solenn |
| Professionals | – | Behavioral: - Therapeutic Alliance Questionnaire (HAQ-CP)Participants in consultations specialising in the treatment of psychotrauma at the Maison de Solenn |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescents suffering from psychotrauma and psychotherapy follow-up in the Consultation Service, Maison de Solenn, Maison des adolescents de l'hôpital Cochin (AP-HP).
Key inclusion criteria (7 listed)
- Teenagers from 12 to 18 years old
- Post-traumatic stress disorder (DSM Criteria 5 Post-Traumatic Stress Disorder)
- Consultant at the Maison de Solenn (Maison des Adolescents)
- Affiliated to a social security scheme
- Parents : parents of adolescents followed at the MDA and agreeing to participate in the study
Key exclusion criteria (2 listed)
- Refusal of the adolescent and/or his/her family (if applicable) to participate in the study,
- Adults (all groups combined): under guardianship or curatorship, under judicial protection
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 |
|---|---|---|
| Semi-structured interviewsSemi-structured interviews | Behavioural | Adolescents, Parents |
| Child Post-Traumatic Stress Response Index (CPTS-RI) scaleChild Post-Traumatic Stress Response Index (CPTS-RI) scale | Behavioural | Adolescents |
| - Therapeutic Alliance Questionnaire (HAQ-CP)- Therapeutic Alliance Questionnaire (HAQ-CP) | Behavioural | Adolescents, Parents, Professionals |
Primary outcome
Semi-structured interviews
Time frame: At the end of the psychotherapy (up to month 12)
Adolescent Psychotherapy Experience = Evolution in semi-structured interviews at the beginning (T1) and end (T2) of psychotherapy (adolescents)
3 secondary outcomes
Child Post-Traumatic Stress Response Index (CPTS-RI) scale
Time frame: At the end of the psychotherapy (up to month 12)
Therapeutic Alliance Questionnaire (HAQ-CP)
Time frame: At the end of the psychotherapy (up to month 12)
Semi-structured interviews
Time frame: At the end of the psychotherapy (up to month 12)
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 23 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Sevan Minassian, MD principal investigator
University Hospital Cochin, Maison des Adolescents - Youth Department, F-75014 Paris, France
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 Post-traumatic Stress Disorder, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 2 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 23 Dec 2025. 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 Sevan Minassian, MD (00 33 1 58 41 24 29, sevan.minassian@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured interviews (time frame: At the end of the psychotherapy (up to month 12)). 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 23 Dec 2025.