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

Study acronym: EMDRJEER
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Primary completion date changed from estimate of Sep 2024 to Oct 15, 2024
    • Interventions: EMDR therapy (Behavioral), Routine Care (Behavioral) to CBT Control therapy (Behavioral), EMDR therapy (Behavioral)
    • Study description revised
    v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Sep 27, 2022
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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
Trial Details
NCT Number NCT05419934
Lead Sponsor Fondation Lenval
Conditions
(from sponsor)
Trauma, Psychological, Stress, Psychological, Anxiety Disorders
Related terms Anxiety Disorders, Psychological Trauma, Stress, Psychological
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov