Early Intervention After Traumatic Exposure in Children and Adolescents

NCT07207018 | Not Yet Recruiting

• 1 other identifier: RECHMPL24_0351
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

CFTSI; Adolescents; Children; Post-Traumatic Stress Disorder; Traumatic event

Outcome Measures

Primary Outcomes (1)

• Evolution of post-traumatic stress symptoms before and after the Child and Family Traumatic Stress Intervention (CFTSI)

  Assessed by the variation in total symptom scores on the Child Posttraumatic Stress Checklist (CPC), child version. This scale is validated in French, with strong psychometric properties. The original English version was designed in accordance with DSM-5 diagnostic criteria. This questionnaire assesses PTSD symptoms and their frequency in children aged 7 to 18, following a traumatic event. The minimum age of 7 years has been maintained since the original validation of the English version. The total score can range from 0 (no symptoms) to 84 (maximum symptoms) for symptom intensity and from 0 (no functional impact) to 24 (maximum functional impact) for functional impairment.

  Baseline, immediately after completion of the program, and 3 months after completion of the program.

Secondary Outcomes (18)

• Evolution of post-traumatic stress symptoms in children at baseline, immediately after completion of the program, and 3 months after completion of the program.

  Baseline, immediately after completion of the program, and 3 months after completion of the program.

• Evolution of post-traumatic stress symptoms in parents, at baseline, immediately after completion of the program, and 3 months after completion of the program.

  Baseline, immediately after completion of the program, and 3 months after completion of the program.

• Correlation between Child Posttraumatic Stress Checklist (CPC) total score (child version) and variables from a socio-demographic and developmental questionnaire

  Baseline

• Correlation between Child Posttraumatic Stress Checklist (CPC) total score and presence of a pre-existing psychiatric or neurodevelopmental disorder prior to the traumatic event (TE)

  Baseline

• Correlation between Child Posttraumatic Stress Checklist (CPC) total score and trauma history

  Baseline

Other Outcomes (3)

• Sociodemograhic data

  Baseline

• Developmental History

  Baseline

• Session adherence : attendance to all core intervention sessions

  During the program period, up to 8 weeks

Study Arms (2)

CFTSI group

EXPERIMENTAL

CFTSI, a 5-session intervention of 1.5 hours each, with one session per week, will be implemented in the experimental group by psychotherapists trained in CFTSI. CFTSI is a brief, structured, and standardized intervention that includes an initial session with the parents alone, a second session with the child alone, and three family sessions. Additionally, 1 to 3 extra sessions may be conducted as needed to clarify certain points or review specific strategies in detail). There is a detailed CFTSI manual describing the progression of each session and precise questionnaires used in each session to measure the intensity and frequency of symptoms, as well as their progression over time.

Behavioral: CFTSI (Child and Family Traumatic Stress Intervention)

Control group

ACTIVE COMPARATOR

The control group will undergo five sessions of 1.5 hours each, with one weekly session, of 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.

Behavioral: non-specific psychological support therapy

Interventions

CFTSI (Child and Family Traumatic Stress Intervention) BEHAVIORAL

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.

CFTSI group

non-specific psychological support therapy BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University Hospital, Toulouse: collaborator
• Centre Hospitalier Universitaire de Nīmes: collaborator
• University Hospital, Thuir: collaborator

Study Sites (1)

CHU Montpellier

Montpellier, Herault, 34000, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Erica EF Fongaro, Post-doc

  University Hospital, Montpellier

  STUDY CHAIR

Central Study Contacts

Hala Dr KERBAGE, Doctor

CONTACT

+ 33 467337246; hala.kerbage@chu-montpellier.fr

Diane DPO Pr Purper-Ouakil, Professor

CONTACT

+ 33 467336009; diane-purper_ouakil@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be multicenter, prospective, controlled, and open-label, with two parallel arms and blinded assessment of the outcome measures. Recruitment will take place among parents consulting for their children at one of the four branches of the Regional Center for Psychotrauma Occitanie (CRPOcc) within three months of the child's exposure to a traumatic event (TE).

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: October 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)