EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial
NCT05419934, Not applicable, Recruiting, Fondation Lenval
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial | ClinicalTrials.gov |
| NCT number | NCT05419934 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondation Lenval | ClinicalTrials.gov |
| Conditions | Trauma, Psychological, Stress, Psychological, Anxiety Disorders | ClinicalTrials.gov |
| Interventions | EMDR therapy, CBT Control therapy | ClinicalTrials.gov |
| First posted | 2022-06-15 | ClinicalTrials.gov |
| Last updated | 2025-04-01 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from baseline of Diagnostic Infant and Preschool Assessment at 3months | at 3 months from inclusion | diagnostic of 13 pathologies, such as post Traumatic stress disorder (PTSD) or others stress related disorders, Anxiety related disorders, and associated disorders. This tool as 517 items. This scale doesn't work on numerical values (there is no min, max or cut scores), this scale makes it possible to confirm or invalidate the presence of symptoms necessary for establishing diagnoses on Diagnosis and Statistical Manual of Mental Disorders (DSMV) criteria. | ClinicalTrials.gov |
| Primary | Diagnostic Infant and Preschool Assessment at 6 months | at 6 months from inclusion | diagnostic of 13 pathologies, such as post Traumatic stress disorder (PTSD) or others stress related disorders, Anxiety related disorders, and associated disorders. This tool as 517 items. This scale doesn't work on numerical values (there is no min, max or cut scores), this scale makes it possible to confirm or invalidate the presence of symptoms necessary for establishing diagnoses on Diagnosis and Statistical Manual of Mental Disorders (DSMV) criteria. | ClinicalTrials.gov |
| Secondary | Preschool Anxiety Assessment | at inclusion, at 3 and 6 months from inclusion | symptoms of anxiety is measure by Preschool Anxiety Scale (PAS) The PAS is a heteroevaluation (for parents or the main care figure) to assess symptomatology of anxiety in children aged 3 to 6 years. This tool has 34 items, based on a 5-points Likert scale, each item is scored from 0 to 4, the PAS has a score ranging from 0 to 112. To interpret this questionnaire, T-scores must be used. T-Scores enable the comparison of a child scores against norms from an equivalent age and gender group from a representative normative sample. | ClinicalTrials.gov |
| Secondary | Parental Stress | at inclusion, at 3 and 6 months from inclusion | symptoms of parental distress and parent-child dysfunctional interaction is performed by Parental Stress Index Screening Form (PSI-SF). The "Parental Stress Index Short Form" is a self-assessment intended for the child's parent The PSI-SF has 36 items from the original 120-item PSI and based on a 5-points Likert scale, each item is scored from 1 to 5, the PSI-SF has a score ranging from 36 to 180. Percentile scores are used to interpret the scores. Scores at or above the 85th percentile are considered high (normal range : 15th-80th percentile) | ClinicalTrials.gov |
| Secondary | symptoms of Post Traumatic Stress Disorder | at inclusion, at 3 and 6 months from inclusion | measure of symptoms of PTSD by Young Child Post-traumatic Stress Disorder Checklist. This scale aims to screen for post-traumatic stress disorder symptoms in children aged 1 to 6 years old, by evaluating traumatic exposures (13 items), symptoms presented by the child (23 items) and his level of impairment or functional impairment (6 items). Items 14 to 36 relate to symptoms of PTSD and are based on a 5-points Likert scale, each item is scored from 0 to 4, the YCPC has a score ranging from 0 to 92. The diagnosis Cutoff is at 26 or more for items 14-36, it indicates a "probable diagnosis" of PTSD. Items 37 to 42 study functional impairment. These items scores can be added together to form a disability score, but they are not used in the PTSD symptom score | ClinicalTrials.gov |
| Secondary | Child Behavior | at inclusion, at 3 and 6 months from inclusion | pathologic behaviors are measured by Child Behavior Checklist " (CBCL) ; The Child Behavior Checklist assesses anxiety, depression, emotional dysregulation, sleep disorders, attention problems, withdrawal behavior, and aggressive behavior. This list of items initially used with children aged 6 to 18 has been adapted for preschoolers. The study plans to use the preschool form (CBCL/ 1.5-5) for children aged 3 years to 5 years and 11 months, and the original CBCL for children aged 6 years to 6 years and 11 months. The Checklist is based on a 3-points Likert scale, each item is scored from 0 to 2, the CBCL has a score ranging from 0 to 230. To interpret this questionnaire, T-scores must be used. | ClinicalTrials.gov |
| Secondary | cognitive function | at inclusion | use of French version of the Wechsler Preschool and Primary Scale of Intelligence ; only the subtests: Picture naming - for children ages 3 to 6 years ; Matrix - for children ages 4 to 6 years; Pictures Memory - for children ages 3 to 3 years and 11 months; Spatial Memory (Zoo location)- for children ages 3 to 6 years; The Wechsler Preschool and Primary Scale of Intelligence (WPPSI) is a cognitive assessment of children aged 2 years and 6 months to 7 years and 7 months. The 4th revision makes it possible to take into account the major stages of the child's cognitive and neurological development. Only subtests that show how the child develops certain major cognitive functions will be administered | ClinicalTrials.gov |
| Secondary | executive functioning | at inclusion | cognitive functioning (executive functioning) measure by french test of Executive Function Assessment Battery for Preschoolers named " La batterie d'évaluation des fonctions exécutives pour enfants d'âge préscolaire " (BEFEX-P) version 4.0 - (Monette \& Bigras, 2017) This evaluation includes two independent tests: a Stroop test adapted to the child, and a tracing tracks. The Stroop fruit is an evaluation of inhibition and flexibility functions in preschool children which is practiced in verbal condition. Trace tracing is a cognitive task that allow the evaluation of executive functions (inhibition and flexibility) in preschool children. | ClinicalTrials.gov |
| Secondary | autobiographical memory | at inclusion | cognitive functioning (autobiographical memory) measure with french test of Autobiographical Memory Evaluation Task named " Tâche d'Evaluation de la Mémoire Autobiographique " (TEMA ; Deplus, de Romree, \& Van Broeck, 2013) The TEMA assessment evaluates the functioning of autobiographical memory in preschool children (children from 3 years to 5 years and 11 months). This test makes the child do exercises to produce autobiographical memories. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Picture Naming Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)