EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial

NCT05419934 | Recruiting

• 1 other identifier: 21-HPNCL-09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to answer to the question of EMDR effectiveness in young children and to determine whether or not the therapy effectiveness is related to the level of cognitive functioning in young children. The study requires a total of 60 children, girls and boys, aged 3 to 6 years and presenting disorders related to stressors, anxiety and/or trauma. Participants will be randomly distributed in two groups: "EMDR therapy" (N=30) group or "control therapy" (N=30) group. The study will take place in four stages: 1/ Pre-treatment phase : An evaluation of child's various cognitive and executive functions, child's symptomatology and parental distress is planned in a pre-treatment phase. 2/ Treatment phase : An EMDR therapy or a routine care is administered to the child between 6 to 10 weeks. 3/ Post-treatment phase : A reassessment of child's and parent's symptoms is planned at the end of treatment. 4/ Continuation of treatment: Children who have received control therapy and without symptomatic improvement will be proposed EMDR treatment. These children will receive the same symptomatic assessments at the end of EMDR treatment. A significant reduction in disorders related to trauma or stress and anxiety factors and their symptomatology, as well as comorbid disorders and their symptomatology, is expected in children who received EMDR therapy compared to the group who received a control therapy. These results are expected to be robust over a period of at least 3 months. The positive effects of EMDR on child symptomatology are also expected to be more pronounced in children showing higher levels of cognitive functioning

Conditions

Trauma, Psychological; Stress, Psychological; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• Change from baseline of Diagnostic Infant and Preschool Assessment at 3months

  diagnostic of 13 pathologies, such as post Traumatic stress disorder (PTSD) or others stress related disorders, Anxiety related disorders, and associated disorders. This tool as 517 items. This scale doesn't work on numerical values (there is no min, max or cut scores), this scale makes it possible to confirm or invalidate the presence of symptoms necessary for establishing diagnoses on Diagnosis and Statistical Manual of Mental Disorders (DSMV) criteria.

  at 3 months from inclusion

• Diagnostic Infant and Preschool Assessment at 6 months

  diagnostic of 13 pathologies, such as post Traumatic stress disorder (PTSD) or others stress related disorders, Anxiety related disorders, and associated disorders. This tool as 517 items. This scale doesn't work on numerical values (there is no min, max or cut scores), this scale makes it possible to confirm or invalidate the presence of symptoms necessary for establishing diagnoses on Diagnosis and Statistical Manual of Mental Disorders (DSMV) criteria.

  at 6 months from inclusion

Secondary Outcomes (7)

• Preschool Anxiety Assessment

  at inclusion, at 3 and 6 months from inclusion

• Parental Stress

  at inclusion, at 3 and 6 months from inclusion

• symptoms of Post Traumatic Stress Disorder

  at inclusion, at 3 and 6 months from inclusion

• Child Behavior

  at inclusion, at 3 and 6 months from inclusion

• cognitive function

  at inclusion

Study Arms (2)

EMDR

EXPERIMENTAL

Patient receiving " EMDR therapy " over 6 to 12 sessions.

Behavioral: EMDR therapy

CBT Control Therapy

SHAM COMPARATOR

Patient receiving the " CBT Control Therapy " over 6 to 12 sessions

Behavioral: CBT Control therapy

Interventions

EMDR therapy BEHAVIORAL

Children will receive an EMDR psychotherapy comprising 8 treatment phases. As the treatment progresses, the child will proceed to desensitize the events of adversity experienced. Phase 1 and 2, before the desensitization phases: 1. History of the patient (collection of anamnesis) 2. Securing the patient, preparing for the desensitization phases Desensitization phases, to be repeated for each traumatic event to be desensitized: 3. Evaluation of the target to be treated 4. Desensitization 5. Installation of positive beliefs 6. Body scanner (verification of body non-response) 7. Closure, verification that the patient is in a stable emotional state allowing him to leave the session Reassessment phase, to be repeated for each traumatic event that has been desensitized: 8. Reassessment of the traumatic target, verification of complete desensitization.

EMDR

CBT Control therapy BEHAVIORAL

Children in the control group receive Cognitive Behavioral Therapy (CBT) administered by the Lenval Foundation (CHU de Nice - France) within the Pediatric Psychotrauma Assessment Center (Centre d'évaluation du psychotraumatisme pédiatrique - CE2P).Cognitive and behavioral therapies are a standard treatment in the care service. Children in the control group will receive CBT specific to the treatment of PTSD in children under 6 years of age. CBT treatments dedicated to early childhood trauma have already been tested in the United States, and have shown evidence of effectiveness in randomized controlled trials (Mc Guire et al., 2021; Scheeringa et al., 2011).

CBT Control Therapy

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Established diagnosis of one or more disorders related to a trauma or a stress factor, and/or an anxiety disorder, assessed by the Diagnostic Infant and Preschool Assessment (DIPA) diagnostic tool
• Typical language

You may not qualify if:

• Child taking a psychotropic treatment
• Suicidal intentions or ideation of the main caregivers, or of the child, and self-harming behavior;
• Parent(s) or care figure(s) with a substance use disorder;
• Presence or diagnosis of specific pathological conditions in the child (neurodevelopmental disorders based on Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria, brain trauma, or neurological pathology);
• Participation of the child in another biomedical research on the psychic care of disorders related to trauma or stress and anxiety factors

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

RECRUITING

MeSH Terms

Conditions

Psychological Trauma; Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Nina MONER

CONTACT

04 92 03 47 70; ninamoner@etu.univ-cotedazur.fr

Andréa SOUBELET, MD

CONTACT

04.92.03.47.70; andrea.soubelet@univ-cotedazur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 15, 2022
• Study Start: September 27, 2022
• Primary Completion: October 15, 2024
• Study Completion: December 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

FR (1)