跳至主要内容
临床试验/NCT05419934
NCT05419934招募中不适用

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.

Fondation Lenval1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Change from baseline of Diagnostic Infant and Preschool Assessment at 3months

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change from baseline of Diagnostic Infant and Preschool Assessment at 3months

时间窗: 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.

Diagnostic Infant and Preschool Assessment at 6 months

时间窗: 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.

次要结局

  • cognitive function(at inclusion)
  • symptoms of Post Traumatic Stress Disorder(at inclusion, at 3 and 6 months from inclusion)
  • Parental Stress(at inclusion, at 3 and 6 months from inclusion)
  • Child Behavior(at inclusion, at 3 and 6 months from inclusion)
  • executive functioning(at inclusion)
  • autobiographical memory(at inclusion)
  • Preschool Anxiety Assessment(at inclusion, at 3 and 6 months from inclusion)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

研究点 (1)

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