Early Intervention After Traumatic Exposure in Children and Adolescents (NCT07207018) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Intervention After Traumatic Exposure in Children and Adolescents
France140 participantsStarted 2025-12
Plain-language 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.
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children aged between 7 and 17 years living in the family home;
* Having been exposed to a traumatic event (TE) in the last 3 months;
* Exhibiting at least one symptom on the Child Post-Traumatic Stress Checklist (CPC);
* Having at least one of the two parents available to participate in the intervention; and
* Having a good command of French, both orally and in writing.
* No participation in other therapeutic interventions aimed at treating traumatic stress symptoms is allowed during the inclusion period.
Exclusion Criteria:
* Parents and/or children in acute and severe emotional distress and/or in a suicidal crisis. During the recruitment interview and signing of the consent letter, the principal investigator will ensure that the volunteer participants are not in acute suicidal crisis or in severe emotional distress requiring urgent care, which would prevent them from participating in a five-session intervention (CFTSI). This emotional distress assessment will be a clinical evaluation based on the clinician's judgment.
* Child in foster care or in the process of being placed.
* Suspected maltreatment or abuse of any kind by the parents.
* Child and/or parent with a known and/or documented intellectual disability.
* Absence of consent from either of the child's parents or the child's non-agreement to participate (appropriately obtained according to the child's developmental age, taking the time to explain the procedure and intervention to the child).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evolution of post-traumatic stress symptoms before and after the Child and Family Traumatic Stress Intervention (CFTSI)
Timeframe: Baseline, immediately after completion of the program, and 3 months after completion of the program.