Sensitivity of the Search for a Heterophory-Vertical-Labile (HV-Labile) for Ambulatory Screening for Specific Learning Disabilities (SLD) or Developmental Coordination Disorder (DCD).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Sensitivity of the HV-Labile to SLD or DCD
研究概览
简要总结
To evaluate, in primary care, the sensitivity of Heterophory-Vertical-Labile (HV-Labile) in ambulatory screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD). in children aged 8 to 12 years.
详细描述
General practitioners during a day of professional training on learning disabilities will be trained to perform the proprioceptive Maddox, to search for a HVLabile.
Each trained practitioner will then test at least six children aged 8 to 12 years old in his or her practice, seen at random
250 to 300 physicians will be trained as part of this research
EXPERIMENTAL DESIGN
- Cross-sectional study with prospective recruitment.
- Search for a Vertical Labile Heterophory (HV-Labile).
- Prescription of a standardized speech and language screening assessment for HV-Labile, and in the same number of children without HV-Labile by secondary coupling.
- Delivery of symptomatic questionnaire.
- In case of learning disabilities, the attending physician should look for a possible etiology.
- Adapted speech therapy care for more than six months.
- Speech and language therapy check-up at more than six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
An adjudication committee to determine the presence or absence of a specific learning disability will be set up, regardless of the presence of a central reference instability.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The population studied is composed of children:
- •from 8 to 12 years old
- •seen for any reason for consultation in general practice
- •Schooled in an ordinary environment since the Preparatory Course in France
- •Francophone parents
- •One of whose parents has signed the consent
- •Consent of the child
- •Social Insured
排除标准
- •The background and living conditions that may promote secondary learning disabilities, for example:
- •Child with a known intellectual disability (Wisc)
- •Child in IME (Institut Médico Educatif)
- •Child followed in SESSAD (Specialised education service at home)
- •Child not knowing how to answer the questions asked
- •Child with a known etiology causing learning disabilities (epilepsy, autism spectrum disorder, hearing impairment, visual impairment (deafness, blindness, low vision))
- •Child on treatment (antiepileptic, neuroleptic, antidepressant, anxiolytic)
- •Child under the care of a psychiatrist,
- •Child followed by the CMP (Centre médico-psychologique)
- •Child living in an institution,
- •Adopted child
- •A child whose mother has experienced known depression during the child's early childhood (0-18 months) because it causes attachment disorders, which can impact the child's development, including learning
- •Child of a family that has lived through more than two family recompositions
- •Child known to be a victim of abuse.
- •Out of school child.
- •To determine the presence of an HV-Labile
- •Child with a known visual correction greater than + or- 2 diopters
- •Known amblyopic child
- •Known strabic child
- •Child with no known binocular vision.
研究组 & 干预措施
Presence of HV-Labile
Presence of vertical heterophoria labile with proprioceptive Maddox
干预措施: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder (Diagnostic Test)
Absence of HV-Labile
Presence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox
干预措施: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder (Diagnostic Test)
结局指标
主要结局
Sensitivity of the HV-Labile to SLD or DCD
时间窗: through study completion, an average of 3 year
Estimated and provided with its 95% confidence interval.
次要结局
- Specificity of the HV-Labile to SLD or DCD(through study completion, an average of 3 year)
- Negative predictive values(through study completion, an average of 3 year)
- Prevalence of children with HV-Labile(through study completion, an average of 3 year)
- Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile(through study completion, an average of 3 year)
- Positive predictive values(through study completion, an average of 3 year)
- Positive and negative likelihood ratios(through study completion, an average of 3 year)
研究者
Luc Virlet
Principal Investigator
Scalab CNRS 9193