NCT05419934 EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial
| NCT ID | NCT05419934 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Lenval |
| Condition | Trauma, Psychological |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-09-27 |
| Primary Completion | 2024-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-09-27 with a primary completion date of 2024-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05419934 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 6 Years, studying Trauma, Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05419934 currently recruiting?
Yes, NCT05419934 is actively recruiting participants. Contact the research team at ninamoner@etu.univ-cotedazur.fr for enrollment information.
Where is the NCT05419934 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT05419934 clinical trial?
NCT05419934 is sponsored by Fondation Lenval. The trial plans to enroll 60 participants.