School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Baseline Spontaneous Language
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 48 Months 至 95 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Non-Verbal School Aged Children with Autism (NVSACA) Intervention (Behavioral)
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.
干预措施: Non-Verbal School Aged Children with Autism (NVSACA) Intervention (Behavioral)
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.
干预措施: Non-Verbal School Aged Children with Autism (NVSACA) Intervention (Behavioral)
结局指标
主要结局
Change in Baseline Spontaneous Language
时间窗: Weekly throughout the 5 month intervention (baseline and 5 months)
The number of unprompted spontaneous language during a 15min play sample.
次要结局
- Change in Baseline Reynell(5 months into treatment (at completion of intervention))
- Changes in Baseline Early Social Communication Scales (ESCS)(5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention)
- Changes in Baseline Structured Play Assessment(5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention)
- Change in Baseline Autism Diagnostic Observation Schedule(5 months into treatment (at completion of intervention))
研究者
Rebecca Landa
Director of the Center for Autism and Related Disorders (CARD) and Professor, Johns Hopkins University School of Medicine
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.