Actively Recruiting

Phase Not Applicable
Age: 3Years - 6Years
All Genders
NCT05419934

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

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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

Age: 3Years - 6Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

Actively Recruiting

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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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