NCT01179841已完成不适用
A Comprehensive Approach to Intervention for Toddlers at Risk for ASD
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2008年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Developmental Level
研究概览
简要总结
This research is being done to test the effectiveness of an early intervention model for very young children at high risk for autism spectrum disorders (ASD) and their families. If children show improvement in this intervention, the investigators hope that the availability of public services of this type will be increased. Children between 11 months and 21 months old with Autism Spectrum Disorders, or with social and communication delays that indicate high risk for Autism Spectrum Disorders, and their parents may join the study. Treatment must start prior to the second birthday.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Months 至 21 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children will be ascertained between 11 months and 21 months of age
- •Must be able to enter the study prior to their second birthday
- •Must then pass an eligibility assessment to determine whether the child meets criteria for ASD and thus qualifies for the study. This assessment will consist of the Baby ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or autism on the ADOS, score more than one standard deviation below the mean on the Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of ASD to be eligible for enrollment into treatment.
- •Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
- •The parent (or other primary caregiver, such as grandparent) in the Parent Enrichment/Training condition must agree to attend the training sessions
排除标准
- •Fail hearing or vision screening (by pediatrician's office, audiologist, or ophthalmologist)
- •Family's first language being other than English (language measures are normed on English speakers, putting non-English speakers at a disadvantage. In addition, the treatment is delivered in English. Children from non-English speaking homes may not make progress, but for reasons other than the efficacy of the intervention.)
- •Head injury (because this may cause some of the symptoms, which may not be due to autism and therefore we would not be able to assess the effects of the intervention on autism)
- •Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous Sclerosis)
- •Inability of the family to attend the playgroup sessions and parent trainings
- •Parents whose hearing or vision is not within normal limits after correction (e.g., hearing aid, glasses)
- •Parents with developmental delays, language or learning impairments, or a psychiatric diagnosis IF the impairment would interfere with parent training (PI will assess on a case by case basis by talking to the parent)
- •Foster children
- •Refusal to allow videotaping of the children's assessments or intervention or to allow videotaped footage to be used for teaching purposes.
结局指标
主要结局
Developmental Level
时间窗: 3 months into treatment, 6 months into treatment, and 6 months after treatment ends
Using the Mullen Scales of Early Learning to assess.
次要结局
- Communication(6 months after treatment ends)
- Presence and Severity of Autism(6 months after treatment ends)
研究者
Rebecca Landa
Principal Investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
研究点 (2)
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