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.

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 6
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpitaux Pédiatriques de Nice CHU-Lenval
RECRUITING
Nice
Contact Information
Primary
Nina MONER
ninamoner@etu.univ-cotedazur.fr
04 92 03 47 70
Backup
Andréa SOUBELET, MD
andrea.soubelet@univ-cotedazur.fr
04.92.03.47.70
Time Frame
Start Date: 2022-09-27
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
Experimental: EMDR
Patient receiving EMDR therapy over 6 to 12 sessions.
Sham_comparator: CBT Control Therapy
Patient receiving the CBT Control Therapy over 6 to 12 sessions
Related Therapeutic Areas
Sponsors
Leads: Fondation Lenval

This content was sourced from clinicaltrials.gov