A Multisystem, Multimodal Intervention for Children With ASD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Flanker Task of Executive Functioning (EF)
研究概览
简要总结
In this study, the investigators will compare effects of two types of 8-weeklong interventions: a) multimodal or b) general movement to facilitate social communication and motor skills of school-age children with Autism Spectrum Disorder (ASD). Recently, the investigators have identified cortical dysfunction patterns as markers of imitation/interpersonal synchrony difficulties in children with ASD using functional near-infrared spectroscopy. In this project, the investigators want to validate whether cortical markers can determine treatment responders and if such markers are sensitive to training-related changes. Following training, the investigators expect to see a variety of behavioral and neural changes in both groups. If the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. This research will build evidence for the use of various movement interventions for school-age children with ASD.
详细描述
46 children with ASD between 5 and 15 years of age will be randomly assigned to the multimodal or general play or seated play groups. Each child will participate in 9 testing sessions (4 pretests, 3 posttests, and 3, 2-month follow-ups) and 8 weeks of multimodal or general intervention between pre-tests and post-tests. In the 8-week phase between the pre- and post-tests, each child will complete group-specific intervention-related activities with the expert clinician twice per week via telehealth or face-to-face interactions. Each session will last for around 1-1.5 hours. If the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. Findings from this research will offer evidence for the use of various movement interventions to promote motor, social communication, and cognitive skills in school-age children with ASD.
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
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with Autism Spectrum Disorder (ASD) between 5 and 15 years of age
排除标准
- •Significant hearing or vision impairment
- •Significant behavioral problems
- •Significant medical (cardiovascular or respiratory), orthopedic, or surgical problems that prevent study participation.
- •History of seizures.
- •Significant mobility problems that prevent study participation.
研究组 & 干预措施
Multimodal
Each child will receive 16 training sessions (8 weeks of training @ 2 sessions per week, approximately 30-45 minutes of interaction time per session) from an expert trainer and parent guidance using telehealth or face-to-face interactions. Within each session, the child will engage in tasks requiring interpersonal synchrony, multilimb coordination (asymmetrical and ipsi/contralateral motions), and balance. Based on feasibility, parents will be given appropriate supplies and trained to promote similar activities at home 1-2 days/week.
干预措施: Multimodal (Behavioral)
General Movement
Each child will receive 16 training sessions (8 weeks of training @ 2 sessions per week, approximately 30-45 minutes of interaction time per session) from an expert trainer and parent guidance using telehealth or face-to-face interactions. Within each session, the child will engage in structured physical activity focused on flexibility, strength, and endurance. Based on feasibility, parents will be given appropriate supplies and trained to promote similar activities at home 1-2 days/week.
干预措施: General (Behavioral)
Standard of Care
Each child will receive 16 training sessions (8 weeks of training @ 2 sessions per week, approximately 30-45 minutes of interaction time per session) from an expert trainer and parent guidance using telehealth or face-to-face interactions. Within each session, the child will engage in seated play focused on reading, building, and art-craft activities. Based on feasibility, parents will be given appropriate supplies and trained to promote similar activities at home 1-2 days/week.
干预措施: Standard of Care (Behavioral)
结局指标
主要结局
Flanker Task of Executive Functioning (EF)
时间窗: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
In the EF task data will be collected. Children will completed the response inhibition task using the Flanker test. This involves making decisions about where a group of fish shown on the screen are looking (right or left). Reaction time in msec were calculated for each response and averaged across trials. Lower values of reaction times indicate faster or better responses.
Number of Prosocial Behaviors
时间窗: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
In a structured play task, the tester assessed a child's ability to engage in prosocial behaviors across multiple helping bids to engage the child in helping behaviors (e.g., clean up of pennies, peg, blocks, cards, and dropped pencils). There are no T or standard scores available for this behavioral measure (not a standardized test). Higher number indicates more prosocial behaviors by the child during the helping bids.
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
时间窗: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
The 3 gross motor coordination and 1 fine manual control composite of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) were administered as a measure of gross and fine motor coordination at each time point. BOT-2 standard scores will be reported for each composite: (i) body coordination composite comprises of balance and bilateral coordination, (ii) the strength/agility composite is comprised of running speed and agility, (iii) upper-limb coordination composite is comprised of upper-limb coordination and manual dexterity, and (iv) the fine manual control composite is comprised of fine motor precision and integration. Standard composite scores on the BOT-2 have a Mean=50 and a standard deviation (SD)=10 for body coordination, strength \& agility, manual coordination and fine motor coordination composite domains. Higher standard scores represent a better outcome. Note there are no T-scores as such for BOT-2; the term often used is a standard BOT composite score.
Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error
时间窗: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
The praxis subtests of Sensory Integration and Praxis Testing (SIPT) are standardized and normed measures of examining motor coordination, sensory integration, and praxis. Specifically, the investigators are planning to use items from subtest of postural praxis subtest. The praxis subtests will examine a child's ability to generalize the imitation skills to novel actions involved in the SIPT postural praxis subtest. This test provides the number of errors per action copied and a total number of errors. There is no fixed range as such but the scores could range from 0 to 100. There are no T or standard scores available for this subtest. Higher number of errors indicates a poor outcome.
Synchrony Errors During the Rhythmic Synchrony Task
时间窗: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
In the rhythmic synchrony task children will perform social drumming (i.e., move in synchrony with an adult as the child follows the adult's drumming motions). Synchrony errors were coded when the child was not matching with the adult for each movement cycle. Higher number of errors indicate a poor outcome. This was an experimental paradigm, and not a standardize measure. Hence, there are no T-scores to report.
次要结局
- Timed-Up & Go Test (TUG)(Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test)
- 2-Minute Walk Test(Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test)
- Developmental Coordination Disorder-Questionnaire(Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test)
- Sensory Processing Measure (SPM)(Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test)