Actively Recruiting
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
Led by Fondation Lenval · Updated on 2025-04-01
60
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of Eye-Movement Desensitization and Reprocessing (EMDR) therapy in young children aged 3 to 6 years who have disorders related to stress, anxiety, or trauma. It also seeks to understand if the therapy's effectiveness is influenced by the children's level of cognitive functioning. The study includes 60 children, both girls and boys, and is designed as a double-blinded randomized controlled trial. Participants will be randomly assigned to one of two groups: one receiving EMDR therapy and the other receiving a control therapy using Cognitive Behavioral Therapy (CBT). The study consists of four main phases: a pre-treatment phase for evaluating cognitive functions and symptoms, a treatment phase lasting 6 to 10 weeks where children receive either EMDR or CBT, a post-treatment phase for reassessment, and a continuation phase offering EMDR treatment to children in the control group who do not show improvement. During the study, children and their parents will undergo several assessments including symptom evaluations and cognitive testing at baseline, 3 months, and 6 months after inclusion. Researchers will measure changes in trauma-related disorders, anxiety, parental stress, child behavior, and cognitive and executive functions. The study expects to observe a significant reduction in symptoms for children receiving EMDR therapy compared to those receiving control therapy, with effects lasting at least three months.
CONDITIONS
Brief 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
- Diagnosed with one or more disorders related to trauma, stress, or anxiety using the Diagnostic Infant and Preschool Assessment
- Typical language development
You will not qualify if you...
- Child currently taking psychotropic medication
- Suicidal intentions or self-harming behavior in child or main caregivers
- Parent(s) or caregiver(s) with substance use disorder
- Child diagnosed with neurodevelopmental disorders, brain trauma, or neurological conditions
- Child participating in another biomedical research on trauma, stress, or anxiety care disorders related to psychic care of disorders related to trauma or stress and anxiety factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants undergo an evaluation of cognitive and executive functions, symptomatology, and parental distress before treatment begins.
1 to 2 visits (in-person)
Duration - 6 to 10 weeks
Participants receive either EMDR therapy or CBT Control therapy over 6 to 12 sessions to address trauma-related disorders, stress, and anxiety.
6 to 12 therapy sessions (in-person)
Duration - Within 1 week after treatment ends
Participants are reassessed for symptoms and parental distress at the end of treatment to evaluate therapy effectiveness.
1 visit (in-person)
Duration - 6 to 10 weeks if applicable
Participants in the control group without symptom improvement are offered EMDR therapy with reassessments following completion.
6 to 12 therapy sessions and 1 reassessment visit (in-person) if applicable
Duration - Up to 6 months
Participants are monitored for sustained effects and symptom changes up to 6 months after inclusion.
Visits at 3 and 6 months post-inclusion (in-person)
Trial Site Locations
Total: 1 location
1
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, France
Actively Recruiting
Research Team
N
Nina MONER
A
Andréa SOUBELET, MD
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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