EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EMDR therapy, CBT Control therapy.
- Who it may be relevant to
- Registry conditions: Trauma, Psychological, Stress, Psychological, Anxiety Disorders. Basic parameters: 3 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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
Detailed description
Eye-Movement Desensitization and Reprocessing (EMDR) therapy is now recommended to anyone suffering from emotional disturbance related to psychological trauma, including babies and very young children. Results of this therapy are promising in young children for PTSD and its comorbidities. However, no studies have documented yet the specific effects of individual EMDR therapy in the 3-6 years children.
The question of the EMDR effectiveness in this population should be investigated first to meet the therapeutic needs in the care management of childhood psychotrauma, and secondly because EMDR therapy involves memory and executive functions that are very immature in children under 6 years old.
Indeed, EMDR involves therapeutic methods such as cognitive restructuring which requires that certain executive functioning components to be functional, even those processes are still developing in young children. EMDR also involves an exposure in the imagination that solicits episodic memories, whereas the ability of young children to retrieve thoses memories is very limited compared to that of adults. Finally, the alternating bilateral stimuli used in EMDR would have an effect on autobiographical memory. However, an infantile amnesia is observed between the ages of 2 and 6, with an absence and then a poverty of autobiographical memories.
Therefore, the present project aims to answer to the question of EMDR effectiveness in young children suffering from stress related disorders, anxiety and/or trauma, but also to determine whether or not the therapy effectiveness is related to the level of cognitive functioning in young children. This 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 treatment and without symptomatic improvement will be proposed EMDR treatment. These children will receive the same symptomatic assessments at the end of EMDR treatment.
In terms of results, 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.
This protocol represents the first randomized controlled trial to investigate effects of an individual EMDR therapy conducted specifically in children aged 3 to 6 years.
Interventions
- Behavioral EMDR therapy
Children will receive an EMDR psychotherapy comprising 8 treatment phases. As the treatment progresses, the child will proceed to desensitize the events of adversity experienced. Phase 1 and 2, before the desensitization phases: 1. History of the patient (collection of anamnesis) 2. Securing the patient, preparing for the desensitization phases Desensitization phases, to be repeated for each traumatic event to be desensitized: 3. Evaluation of the target to be treated 4. Desensitization 5. - Behavioral CBT Control therapy
Children in the control group receive Cognitive Behavioral Therapy (CBT) administered by the Lenval Foundation (CHU de Nice - France) within the Pediatric Psychotrauma Assessment Center (Centre d'évaluation du psychotraumatisme pédiatrique - CE2P).Cognitive and behavioral therapies are a standard treatment in the care service. Children in the control group will receive CBT specific to the treatment of PTSD in children under 6 years of age. CBT treatments dedicated to early childhood trauma have
Primary outcome measures
- Change from baseline of Diagnostic Infant and Preschool Assessment at 3months [Time frame: at 3 months from inclusion]
- Diagnostic Infant and Preschool Assessment at 6 months [Time frame: at 6 months from inclusion]
Secondary outcome measures (7)
- Preschool Anxiety Assessment [Time frame: at inclusion, at 3 and 6 months from inclusion]
- Parental Stress [Time frame: at inclusion, at 3 and 6 months from inclusion]
- symptoms of Post Traumatic Stress Disorder [Time frame: at inclusion, at 3 and 6 months from inclusion]
- Child Behavior [Time frame: at inclusion, at 3 and 6 months from inclusion]
- cognitive function [Time frame: at inclusion]
- executive functioning [Time frame: at inclusion]
- autobiographical memory [Time frame: at inclusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
France · 1 center
- Hôpitaux Pédiatriques de Nice CHU-Lenval — Nice
Identifiers
NCT: NCT05419934 · 21-HPNCL-09