Early Intervention After Traumatic Exposure in Children and Adolescents
NCT07207018 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2025-10-03
Summary
The aim of this interventional research is to evaluate the effectiveness of CFTSI in reducing post-traumatic symptoms measured using the CPC, child version, at the end of CFTSI treatment in children and adolescents aged between 7 and 17 years, exposed to an ET in the last 3 months. The main question(s) it aims to answer \[is/are\]:
* CFTSI reduces posttraumatic Child Posttraumatic Stress Checklist (CPC) scores in children exposed to ET, both immediatly after completion of the CFTSI and at 3 months after completion.
* CFTSI reduces post-traumatic scores in parents on the PTSD Checklist for DSM5 (PCL), both immediatly after completion of the CFTSI and at 3 months after completion.
* researchers will compare the reduction in post-traumatic symptoms between participants receiving CFTSI and those receiving non-specific child-centred psychological support. Symptoms will be assessed using the PCL in parents and the CPC in children and adolescents, immediately after completion of the program and again at 3 months after completion.
The participants will be randomised into two groups, one that will undergo CFTSI and one that will undergo supportive psychological therapy. Each participant will receive one session per week over five weeks, and possibly 1 to 3 additional sessions if necessary over a further three weeks, and will then be reviewed three months later.
Conditions
- Post-traumatic Stress Disorder (PTSD)
Interventions
- BEHAVIORAL
-
CFTSI (Child and Family Traumatic Stress Intervention)
CFTSI is a family-centered intervention lasting five to eight sessions, aiming to strengthen parental support for the child by facilitating the identification of the child's typical responses to traumatics events, improving communication between the child and the parent, and teaching coping strategies and behavioral interventions to both parents and children to reduce acute post-traumatic reactions.
- BEHAVIORAL
-
non-specific psychological support therapy
non-specific psychological support therapy, focused on the child rather than the family, and aimed at supporting the child and strengthening their daily adaptation. This support therapy is already integrated into the standard practice of the CRPOCC, but will be conducted by psychotherapists from the Montpellier University Hospital who are not trained in CFTSI, to ensure a consistent format that facilitates comparisons between the two groups. The number of sessions may be increased to a total of eight sessions if the clinician determines that additional aspects need to be addressed during the sessions.
Sponsors & Collaborators
-
University Hospital, Toulouse
collaborator OTHER -
Centre Hospitalier Universitaire de Nīmes
collaborator OTHER -
University Hospital, Thuir
collaborator UNKNOWN -
University Hospital, Montpellier
lead OTHER
Principal Investigators
-
Erica EF Fongaro, Post-doc · University Hospital, Montpellier
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-31
- Primary Completion
- 2027-08-31
- Completion
- 2027-08-31
Countries
- France
Study Locations
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