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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06138522
Other study ID # APHP231046
Secondary ID 2023-A01689-36
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2023
Est. completion date June 2027

Study information

Verified date January 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Sevan Minassian, MD
Phone 00 33 1 58 41 24 29
Email sevan.minassian@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 2027
Est. primary completion date November 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Semi-structured interviews
Semi-structured interviews
Child Post-Traumatic Stress Response Index (CPTS-RI) scale
Child Post-Traumatic Stress Response Index (CPTS-RI) scale
- Therapeutic Alliance Questionnaire (HAQ-CP)
- Therapeutic Alliance Questionnaire (HAQ-CP)

Locations

Country Name City State
France University Hospital Cochin, Maison des Adolescents - Youth Department, F-75014 Paris, France Paris IDF

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Semi-structured interviews 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 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.
At the end of the psychotherapy (up to month 12)
Secondary 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).
At the end of the psychotherapy (up to month 12)
Secondary Semi-structured interviews Experience at the end (T2) of psychotherapy (parents) At the end of the psychotherapy (up to month 12)
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