EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial
Launched by FONDATION LENVAL · Jun 10, 2022
Trial Information
Current as of September 08, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effectiveness of a therapy called EMDR (Eye Movement Desensitization and Reprocessing) for young children aged 3 to 6 who are dealing with trauma, stress, or anxiety disorders. The study will include 60 children, who will be randomly assigned to either receive EMDR therapy or routine care for their conditions. Researchers want to see if EMDR can help reduce symptoms related to trauma and anxiety, especially in children with higher cognitive functioning, which refers to thinking and understanding abilities.
To participate, children must have a diagnosed anxiety or trauma-related disorder and be able to speak normally. They cannot be on certain medications or have specific health conditions. During the trial, children will first be evaluated to understand their needs, then receive treatment over several weeks, and finally be reassessed to see how they have improved. If children who start with routine care don’t see improvements, they will be offered EMDR therapy afterward. This study aims to find out if EMDR is more effective than regular care in helping young children cope with their emotional challenges.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Child aged 3 to 6 at the time of inclusion;
- • 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
- Exclusion Criteria:
- • 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
About Fondation Lenval
Fondation Lenval is a prominent clinical trial sponsor dedicated to advancing pediatric healthcare through innovative research and development. Based in Nice, France, the foundation focuses on improving treatments and outcomes for children with various medical conditions, particularly in the fields of neonatology and pediatrics. By collaborating with leading healthcare professionals and institutions, Fondation Lenval aims to bridge the gap between clinical practice and research, ensuring that its studies adhere to the highest ethical standards and regulatory requirements. Through its commitment to enhancing child health and well-being, the foundation plays a crucial role in shaping the future of pediatric medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nice, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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