Effects of Self-Generated Experiences on Social Cognitive Development in Young Children With Autism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in Baseline Eye Tracking Tasks
研究概览
简要总结
Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Months 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be 24 to 42 months old
- •Children must meet criteria for ASD or autism on the ADOS (Lord et al., 2000) plus receive a clinical judgment of PDD-NOS or autism by the study team
- •Score ≥ 16 months on the Visual Receptive subtest and ≥ 9 months on the Receptive Language subtest on the Mullen Scales of Early Learning and/or the Vineland Adaptive Behavior Scales at the time of eligibility testing.
- •The parent (or other primary caregiver, such as grandparent) in the PE condition must agree to attend the training sessions each week for the 5-month period.
- •The parent must agree to bring their child in for testing at all testing points (pre-testing, post-testing, follow-up testing).
- •Parents must be between the ages of 18 and 65 years old
- •It is not required that English be their primary language, but they must be fluent in English (or if the child is nonverbal he/she must hear English most of the time at home)
排除标准
- •<34 weeks or >42 weeks gestational age
- •<2500 grams birth weight, severe birth trauma
- •Head or serious bodily injury sustained before or during the study
- •Illicit drug or excessive alcohol exposure (defined in our telephone screening interview)
- •Major hearing or visual impairment
- •Non-febrile seizures
- •Any known genetic syndrome
- •Mitochondrial disorders
- •Severe birth defects
- •No foster children may participate
- •The child must not be adopted
- •The child must not be participating in another intervention study simultaneously or be simultaneously enrolled in the CARD clinic's Achievements, Early Achievements, TIPS, Jump Start, or Play with Me programs.
- •Unable to provide baseline data on the eye tracking measure at time of pretesting (e.g., tracker unable to read eye movements)
- •Has a sibling participating in this study
结局指标
主要结局
Change in Baseline Eye Tracking Tasks
时间窗: 5 months into treatment and 5 months after the treatment ends
Change in Baseline Spontaneous Imitation Task
时间窗: 5 months into treatment and 5 months after the treatment ends
Change in Baseline Communication and Symbolic Behavior Scale Developmental Profile
时间窗: 5 months into treatment and 5 months after the treatment ends
次要结局
- Change in Baseline Action/intention understanding taks(5 months into treatment and 5 months after the treatment ends)
- Change in Baseline Autism Diagnostic Observation Schedule(5 months into treatment and 5 months after the treatment ends)
- Change in Baseline Mullen Scales of Early Learning(5 months into treatment and 5 months after the treatment ends)
研究者
Rebecca Landa
Principal Investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.