EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial

Официальное название

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.

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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

Первичные конечные точки

• Change from baseline of Diagnostic Infant and Preschool Assessment at 3months [Срок оценки: at 3 months from inclusion]
• Diagnostic Infant and Preschool Assessment at 6 months [Срок оценки: at 6 months from inclusion]

Вторичные конечные точки (7)

• Preschool Anxiety Assessment [Срок оценки: at inclusion, at 3 and 6 months from inclusion]
• Parental Stress [Срок оценки: at inclusion, at 3 and 6 months from inclusion]
• symptoms of Post Traumatic Stress Disorder [Срок оценки: at inclusion, at 3 and 6 months from inclusion]
• Child Behavior [Срок оценки: at inclusion, at 3 and 6 months from inclusion]
• cognitive function [Срок оценки: at inclusion]
• executive functioning [Срок оценки: at inclusion]
• autobiographical memory [Срок оценки: at inclusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• Hôpitaux Pédiatriques de Nice CHU-Lenval — Nice

Идентификаторы

NCT: NCT05419934 · 21-HPNCL-09

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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