The Effect of Play on Social and Motor Skills of Children With ASD
NCT ID: NCT04258254
Last Updated: 2023-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2020-06-04
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Multimodal
Multimodal intervention will involve hello songs, warm up mainly involve sensory and stretching games, music time involves playing instruments, moving game involves use of music or songs to move the whole body, yoga involves themes/songs to perform yoga poses, and good bye involves a goodbye song and reflections about the session. In all movement conditions, trainers emphasize complex and multilimb coordination (asymmetrical and ipsi/contralateral movements) and balance.
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.
General
The general exercise group will begin with hello games/set up and end with reflections and cleanup. Children will engage in limb and body warmup routines, specific strengthening exercises (single-joint/single-limb/symmetrical), moderate intensity endurance exercises involving various obstacle courses, and a cool down routine.
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.
Standard of Care
The seated play group will also begin with hello/icebreaker games and end with goodbye and cleanup. In between, they will read books and review the story line and overall message and engage in fine-motor activities involving building supplies and art-craft.
Interventions
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Multimodal
Multimodal intervention will involve hello songs, warm up mainly involve sensory and stretching games, music time involves playing instruments, moving game involves use of music or songs to move the whole body, yoga involves themes/songs to perform yoga poses, and good bye involves a goodbye song and reflections about the session. In all movement conditions, trainers emphasize complex and multilimb coordination (asymmetrical and ipsi/contralateral movements) and balance.
General
The general exercise group will begin with hello games/set up and end with reflections and cleanup. Children will engage in limb and body warmup routines, specific strengthening exercises (single-joint/single-limb/symmetrical), moderate intensity endurance exercises involving various obstacle courses, and a cool down routine.
Standard of Care
The seated play group will also begin with hello/icebreaker games and end with goodbye and cleanup. In between, they will read books and review the story line and overall message and engage in fine-motor activities involving building supplies and art-craft.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
5 Years
15 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of General Medical Sciences (NIGMS)
NIH
University of Delaware
OTHER
Responsible Party
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Principal Investigators
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Anjana N Bhat, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Delaware
Locations
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University of Delaware
Newark, Delaware, United States
Countries
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References
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Su WC, Cleffi C, Srinivasan S, Bhat A. A Pilot Study Comparing the Efficacy, Fidelity, Acceptability, and Feasibility of Telehealth and Face-to-Face Creative Movement Interventions in Children with Autism Spectrum Disorder. Telemed Rep. 2024 Mar 21;5(1):67-77. doi: 10.1089/tmr.2023.0061. eCollection 2024.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1539736-1
Identifier Type: -
Identifier Source: org_study_id
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