- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04258254
The Effect of Play on Social and Motor Skills of Children With ASD
A Multisystem, Multimodal Intervention for Children With ASD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anjana Bhat, PhD
- Phone Number: 4435238680
- Email: abhat@udel.edu
Study Contact Backup
- Name: Lavonne Sumler, MS
- Phone Number: 302-831-0216
- Email: lsumler@udel.edu
Study Locations
-
-
Delaware
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Newark, Delaware, United States, 19713
- University of Delaware
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with Autism Spectrum Disorder (ASD) between 5 and 15 years of age
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
Other Names:
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Active Comparator: 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.
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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.
Other Names:
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Active Comparator: 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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)
Time Frame: 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.
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Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error
Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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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.
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Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Flanker Task of Executive Functioning (EF)
Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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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.
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Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Synchrony Errors During the Rhythmic Synchrony Task
Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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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.
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Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Number of Prosocial Behaviors
Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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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.
|
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
2-Minute Walk Test
Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Testers will use the 2-minute walk test to assess endurance of the participating children.
The test will be chosen based on the walking tolerance of the child and the severity of locomotor impairments.
The test assesses the maximum distance that the child can cover in 1 or 2 minutes.
The 2-minute walk test distance has been found to be highly correlated with the gold standard 6-minute walk test commonly used to assess endurance.
This test provides a distance measure and more the distance covered indicates better performance.
The distance covered may range from 125-200 meters approximately.
There are no T or standard scores available for this functional measure.
Higher distance covered number indicates a better outcome.
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Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Timed-Up & Go Test (TUG)
Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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The Timed-Up & Go test (TUG) measures the time taken in seconds to stand up from a chair with armrest, walk 3 meters, turn around, walk back to the chair, and sit down again.
A higher value indicates poor performance and time taken is usually between 4 to 7 seconds.
There are no T or standard scores available for this functional measure.
Lower value of time taken indicates better outcome.
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Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Developmental Coordination Disorder-Questionnaire
Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Motor coordination questionnaire provides a total score of motor performance. For Children Ages 5 years 0 months to 7 years 11 months, a score between 15 to 46 is an indication of DCD or suspect DCD and a score between 47 to 75 is probably not DCD. For Children Ages 8 years 0 months to 9 years 11 months, a score of 15 to 55 is an indication of DCD or suspect DCD and a score between 56 to 75 is probably not DCD. For Children Ages 10 years 0 months to 15 years, a score of 15 to 57 is an indication of DCD or suspect DCD and a score between 58 to 75 is probably not DCD. Higher number indicates better motor performance. There are no other T-scores associated with this measure. |
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Sensory Processing Measure (SPM)
Time Frame: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Sensory Processing Measure (SPM) measures assesses challenges with social participation as well as sensory challenges.
A standard T-score of 60-70 indicates some problems and a range of 70-80 indicates definite problems.
Note the SPM T-score has a mean of 50 and a standard deviation (SD) of 10.
Note a higher T-score indicates greater sensory processing problems.
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Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social Communication Questionnaire (SCQ)
Time Frame: In the screening phase after initial contact with researchers
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The Social Communication Questionnaire (SCQ) is a 15-minute parent questionnaire to screen for autism-specific, social communication behaviors of children above three years of age.
A higher SCQ total score indicates a greater social communication delay.
The SCQ scores may range from 0 to 39.
There are no T or standard scores available for this screening measure.
Higher number indicates more autistic severity.
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In the screening phase after initial contact with researchers
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Vineland Adaptive Behavioral Scales (VABS)
Time Frame: In the baseline period
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The Vineland Adaptive Behavioral Scales (VABS) is a 20-minute parent questionnaire/interview that assess a child's overall development/adaptive functioning and includes subscales of motor (gross motor, fine motor), socialization (interpersonal relationships, play, and coping skills), and communication (receptive, expressive, and written language) as well as adaptive functioning (personal, domestic, and community) for individuals between birth to 90 years of age.
The VABS will provides us information on overall functioning based on the adaptive behavior composite (ABC) score.
All participants will complete this measure to receive an ABC score of overall functioning.
A higher VABS standard score indicates better functional performance for a given subdomain or overall.
The VABS standard scores range from 1-100 with 100 being best performance.
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In the baseline period
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Social Responsiveness Scale-Second Edition (SRS-2)
Time Frame: Only completed once at pretest.
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Social Responsiveness Scale-Second Edition (SRS-2)(Constantino, 2012) (10 minutes): The SRS is a survey instrument designed to measure autism severity (i.e., social skill deficits that are commonly experienced by individuals with autism spectrum disorders).
The SRS includes survey questions that measure skills across five different domains: Social Awareness, Social Cognition, Social Communication, Social Motivation, and Restricted Interests and Repetitive Behavior.
An overall T-score of <59 is within the normal range, 60-75 is a mild-to-moderate impairment, and a T-score >75 indicates a severe impairment.
Note the SRS T-score has a mean of 50 and a standard deviation (SD) of 10.
Note a higher T-score indicates greater autistic severity.
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Only completed once at pretest.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anjana N Bhat, PhD, University of Delaware
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1539736-1
- 3P20GM103446-19S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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