RecruitingNot ApplicableNCT05419934

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

Is Eye-Movement Desensitization and Reprocessing (EMDR) Therapy Effective in Children Aged 3 to 6 Years With Trauma-related Disorders or Stressors and Anxiety? A Double-blinded Randomized Controlled Trial.

Sponsor

Fondation Lenval

Enrollment

60 participants

Start Date

Sep 27, 2022

Study Type

INTERVENTIONAL

Conditions

Anxiety Disorders Stress, Psychological Trauma, Psychological

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

Eligibility

Min Age: 3 YearsMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study is testing EMDR (Eye Movement Desensitization and Reprocessing) therapy in very young children aged 3 to 6 who have experienced trauma or stress and have developed anxiety or stress-related disorders. EMDR is a structured therapy that uses guided eye movements to help process difficult memories. **You may be eligible if...** - Your child is between 3 and 6 years old at the time of enrollment - Your child has been diagnosed with a trauma-related disorder or anxiety disorder (assessed using a standardized diagnostic tool) - Your child has typical language development for their age **You may NOT be eligible if...** - Your child has a known neurological condition or developmental disability - Your child has a severe psychiatric condition that requires immediate intensive treatment - Your family is currently in a crisis situation that prevents regular attendance - Your child has already received or is currently receiving EMDR therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALEMDR therapy

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.

BEHAVIORALCBT Control therapy

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).