Validation of a Salivary miRNA Diagnostic Test for Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,604
- 试验地点
- 16
- 主要终点
- Salivary miRNA Profile
研究概览
简要总结
This study involves sample collection to identify biomarkers relating to Autism Spectrum Disorder(ASD) in the saliva of children who are between the ages of 18 months to 6 years and 11 months. Participants will at each timepoint have a non-invasive saliva swab collected and complete a brief demographic and medical history questionnaire as well. Children in the pediatric/provider setting who will receive a referral for an ASD diagnosis because they were determined to have a suspicion of developing ASD will be enrolled in the study. Children will also be enrolled in the specialist evaluation setting where they will receive a DSM-5 diagnosis. A subset of both enrollment cohorts will also be followed up with at a third time point in which their diagnosis will be confirmed, and information about any ongoing treatment will be gathered.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 through 83 months old
- •The study will include children "at risk" for ASD as defined by meeting one or more of the following criteria:
- •flagged positive on a developmental screening tool (see below for assessment cut off scores)
- •the child has a biological sibling with ASD
- •Significant provider concern based on parent report noted in the child's medical chart at the time of the appointment.
- •Significant parental concern
排除标准
- •Feeding tube dependence
- •Active periodontal disease
- •Confounding neurological condition (i.e. cerebral palsy, epilepsy)
- •Sensory impairments (i.e. blindness or deafness)
- •Acute illnesses (i.e. upper respiratory infection)
- •Currently on antibiotics
- •Had taken antibiotics within the previous 30 days
- •Wards of the state
结局指标
主要结局
Salivary miRNA Profile
时间窗: At the time of collection (from 18 months to 6 years 11 months of age)
Measures of miRNA abundance in saliva
DSM-5 Diagnosis
时间窗: At the time of the diagnostic evaluation
Confirmation of participants meeting or not meeting the DSM-5 Criteria for a diagnosis of Autism Spectrum Disorder
次要结局
未报告次要终点