- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06138522
Qualitative Study on the Perception of Changes in the Psychotherapy of Traumatized Young People (TRAUMADOPSY)
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 Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sevan Minassian, MD
- Phone Number: 00 33 1 58 41 24 29
- Email: sevan.minassian@aphp.fr
Study Contact Backup
- Name: Marie Benhammani
- Phone Number: 00 33 1 58 41 11 90
- Email: marie.godard@aphp.fr
Study Locations
-
-
IDF
-
Paris, IDF, France, 75014
- Recruiting
- University Hospital Cochin, Maison des Adolescents - Youth Department, F-75014 Paris, France
-
Contact:
- Sevan Minassian
- Phone Number: 00 33 1 58 41 24 29
- Email: sevan.minassian@aphp.fr
-
Contact:
- Khadija Chahraoui
-
Sub-Investigator:
- Marie Rose Moro, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adolescents
Participants in consultations specialising in the treatment of psychotrauma at the Maison de Solenn
|
Semi-structured interviews
Child Post-Traumatic Stress Response Index (CPTS-RI) scale
- Therapeutic Alliance Questionnaire (HAQ-CP)
|
|
Parents
Participants in consultations specialising in the treatment of psychotrauma at the Maison de Solenn
|
Semi-structured interviews
- Therapeutic Alliance Questionnaire (HAQ-CP)
|
|
Professionals
Participants in consultations specialising in the treatment of psychotrauma at the Maison de Solenn
|
- Therapeutic Alliance Questionnaire (HAQ-CP)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
At the end of the psychotherapy (up to month 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi-structured interviews
Time Frame: At the end of the psychotherapy (up to month 12)
|
Experience at the end (T2) of psychotherapy (parents)
|
At the end of the psychotherapy (up to month 12)
|
|
Child Post-Traumatic Stress Response Index (CPTS-RI) scale
Time Frame: At the end of the psychotherapy (up to month 12)
|
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. |
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)
|
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). |
At the end of the psychotherapy (up to month 12)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sevan Minassian, MD, University Hospital Cochin, Maison des Adolescents - Youth Department, F-75014 Paris, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP231046
- 2023-A01689-36 (Other Identifier: French Ministry of Health)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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