School-Age Children With Autism With Limited Expressive Language Skills
2021年3月9日 更新者：Rebecca Landa、Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study
This project will address a major challenge to the field of autism research: improving expressive communication in children with autism who have reached school age but have not acquired functional spoken language (non-verbal school aged children with autism; NVSACA).
Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger site and follow-up testing but continue to have minimal functional spoken language will be participants in this study. After eligibility is established, participants will be randomly assigned to a baseline duration of one week, two weeks or three weeks before the start of active treatment. Once the baseline duration is completed, participants begin active treatment one hour of intervention three days per week in the participants' school setting. In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to improve the child's generalization of skills and teach parents the strategies implemented in their child's treatment. Post-baseline and post-treatment assessments will be completed in the lab at a time that is convenient for the participants' families.
研究概览
研究类型
介入性
注册 (实际的)
13
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Maryland
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Baltimore、Maryland、美国、21211
- Kennedy Krieger Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
4年 至 7年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of autism by a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by the Autism Diagnostic Observation Schedule (ADOS; Lord, Rutter, DiLavore, & Risi, 1999)
- Chronological age between 4.0 years and 7 years, 11 months
- Reynell developmental score ≤ 24 months, ADOS A1 score of 2, 3 or 8
- Nonverbal IQ of ≥ 40 (Leiter International Performance Scale-Revised (Leiter-R), Roid & Miller, 2007)
- Children have participated in and completed follow-up testing for the ICAN study.
Exclusion Criteria:
- Major medical conditions other than autism (e.g., genetic disorders [e.g., Fragile X, Down syndrome, tuberous sclerosis], blindness or deafness, and motor disabilities such as cerebral palsy;
- Uncontrolled seizures;
- Self-injurious behavior or moderate to severe aggression.
- Children in foster care.
- Children who are exposed to < 50% English throughout their typical day.
- Children currently participating in another intervention/treatment study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 1 week before your child begins active treatment with their interventionist.
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The intervention has 3 components:
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实验性的：2 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 2 weeks before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
|
|
实验性的：3 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 3 weeks before your child begins active treatment with their interventionist.
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The intervention has 3 components:
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Baseline Spontaneous Language
大体时间：Weekly throughout the 5 month intervention (baseline and 5 months)
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The number of unprompted spontaneous language during a 15min play sample.
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Weekly throughout the 5 month intervention (baseline and 5 months)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change in Baseline Autism Diagnostic Observation Schedule
大体时间：5 months into treatment (at completion of intervention)
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5 months into treatment (at completion of intervention)
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Change in Baseline Reynell
大体时间：5 months into treatment (at completion of intervention)
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5 months into treatment (at completion of intervention)
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Changes in Baseline Early Social Communication Scales (ESCS)
大体时间：5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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Changes in Baseline Structured Play Assessment
大体时间：5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年1月1日
初级完成 (实际的)
2013年12月1日
研究完成 (实际的)
2013年12月1日
研究注册日期
首次提交
2012年2月6日
首先提交符合 QC 标准的
2012年2月8日
首次发布 (估计)
2012年2月9日
研究记录更新
最后更新发布 (实际的)
2021年3月10日
上次提交的符合 QC 标准的更新
2021年3月9日
最后验证
2021年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.