Actively Recruiting
EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial
Led by Fondation Lenval · Updated on 2025-04-01
60
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged 3 to 6 at the time of inclusion
- Established diagnosis of one or more disorders related to trauma, stress, or anxiety assessed by Diagnostic Infant and Preschool Assessment (DIPA)
- Typical language development
You will not qualify if you...
- Child currently taking psychotropic treatment
- Suicidal intentions or self-harming behavior in child or main caregivers
- Parent(s) or caregivers with substance use disorder
- Child diagnosed with neurodevelopmental disorders, brain trauma, or neurological pathology
- Child participating in another biomedical research related to trauma, stress, or anxiety care
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, France
Actively Recruiting
Research Team
N
Nina MONER
CONTACT
A
Andréa SOUBELET, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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