Back to resultsThe Effect of Play on Social and Motor Skills of Children With ASD
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multimodal
General
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Movement, Play, Social, Communication, Motor
Eligibility Criteria
Inclusion Criteria:
- Children with Autism Spectrum Disorder (ASD) between 6 and 14 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.
Sites / Locations
- University of DelawareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Multimodal
General Movement
Standard of Care
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Change in cortical activation during the Rhythmic Synchrony task
In the rhythmic synchrony task children will perform, drum, march, and sway actions across the following conditions - solo actions - moving to a rhythmic beat played aloud in the background), social actions - move in synchrony with the adult as the child follows the adult's drumming motions. The adult will be listening to the rhythmic beat only not the child. Testers will also attach 5 tiny inertial measurement units to the two wrists, mid-back (2nd sacral vertebra), and on both shoes (at the 1st metatarsal head) using wrist/waist bands or velcro for the child and the adult partner to measure moment-to-moment kinematics and relative phasing/coordination between limbs and between people. A cap with probes will be used to record the oxyhemoglobin concentration in mmol.mm from different brain regions as a measure of cortical activation. A higher value indicates greater cortical activation/neural processing.
Change in cortical activation during a building task
In the building task cortical activation data will be collected using a cap with probes. In the Tower of Hanoi building task, children will complete two tasks : a) response inhibition task using the Flanker test and b) cognitive flexibility task using the Reverse Flanker test. Both involve finger pointing in one direction or another to make decisions about where the group of fish shown on the screen are looking (right or left). Oxyhemoglobin concentration in mmol.mm from different brain regions are a measure of cortical activation. A higher value indicates greater cortical activation/neural processing.
Change in joint attention scores
In the Joint Attention Test, the child and tester are seated across from each other at a table. The environment is set up such that objects are placed in specific locations. The scale consists of eight naturalistic prompts designed to elicit response or initiation of joint attention. Each prompt is scored on a four-point scale (i.e., social action, looking at the tester's face, make eye contact, and a verbal response). Scores are between 0 to 38.
Change in gross-motor performance scores
The fine and gross motor coordination subtests of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOTMP-2) are a standardized and normed measure of gross and fine motor coordination. BOTMP-2 provides a raw, standard, and percentile scores. BOTMP-2 has eight subtests (running speed and agility, balance, bilateral coordination, strength, upper-limb coordination, response speed, visual-motor control, and upper-limb speed and dexterity). Testers will administer a short form of BOTMP-2 as well as the subtests for balance, bilateral coordination, manual dexterity, strength, fine motor precision, and fine motor integration, and upper-limb coordination subtests. The test provides percentile score that range from 0-100.
Change in praxis errors
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 subtests of postural praxis, and bilateral motor coordination subtest. The praxis subtests will examine a child's ability to generalize the imitation skills to novel actions involved in the SIPT praxis subtests. 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.
Change in movement quality and prosocial behaviors
In the structured play task, the testers will assess a child's ability to engage in prosocial behaviors as well as task-specific upper and lower-limb gross motor coordination skills. First, the tester will pretend to need help opening a tube or in collecting dropped items to see if the participating child will assist in opening or cleaning up of blocks. Next, the testers will perform multiple object control and locomotor skills consistent with the musical activities practiced during the training weeks. The test includes ball skills such as throwing, catching, dribbling, as well as locomotor skills of jump, hop, gallop, etc. developed using the items from the Test of Gross Motor Development-2nd edition (TGMD-2). Two trials of each action will be recorded. This task includes raw, standard, and percentile scores. Higher scores indicate better performance and range from 0-100.
Secondary Outcome Measures
Change in distance covered during walking
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.
Changes in time taken to complete the task
The Timed-Up & Go test (TUG) test 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.
Developmental Coordination Disorder-Questionnaire
Motor coordination questionnaire
Sensory Processing Measure (SPM)
SPM measures changes in social participation as well as other sensory-motor preferences across intervention.
Full Information
NCT ID
NCT04258254
First Posted
January 24, 2020
Last Updated
January 4, 2021
Sponsor
University of Delaware
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT04258254
Brief Title
The Effect of Play on Social and Motor Skills of Children With ASD
Official Title
A Multisystem, Multimodal Intervention for Children With ASD
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
45 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 a total of 30-45 minutes. 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 for school-age children with ASD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Movement, Play, Social, Communication, Motor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participating children are matched on age, gender, and level of functioning. Matched pairs will be randomized to a) multimodal or b) general movement or c) standard of care, seated play group.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multimodal
Arm Type
Experimental
Arm Description
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.
Arm Title
General Movement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multimodal
Other Intervention Name(s)
Coordination/Balance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General
Other Intervention Name(s)
Physical Activity, Strength, Endurance
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Sedentary or Seated Play
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in cortical activation during the Rhythmic Synchrony task
Description
In the rhythmic synchrony task children will perform, drum, march, and sway actions across the following conditions - solo actions - moving to a rhythmic beat played aloud in the background), social actions - move in synchrony with the adult as the child follows the adult's drumming motions. The adult will be listening to the rhythmic beat only not the child. Testers will also attach 5 tiny inertial measurement units to the two wrists, mid-back (2nd sacral vertebra), and on both shoes (at the 1st metatarsal head) using wrist/waist bands or velcro for the child and the adult partner to measure moment-to-moment kinematics and relative phasing/coordination between limbs and between people. A cap with probes will be used to record the oxyhemoglobin concentration in mmol.mm from different brain regions as a measure of cortical activation. A higher value indicates greater cortical activation/neural processing.
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Title
Change in cortical activation during a building task
Description
In the building task cortical activation data will be collected using a cap with probes. In the Tower of Hanoi building task, children will complete two tasks : a) response inhibition task using the Flanker test and b) cognitive flexibility task using the Reverse Flanker test. Both involve finger pointing in one direction or another to make decisions about where the group of fish shown on the screen are looking (right or left). Oxyhemoglobin concentration in mmol.mm from different brain regions are a measure of cortical activation. A higher value indicates greater cortical activation/neural processing.
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Title
Change in joint attention scores
Description
In the Joint Attention Test, the child and tester are seated across from each other at a table. The environment is set up such that objects are placed in specific locations. The scale consists of eight naturalistic prompts designed to elicit response or initiation of joint attention. Each prompt is scored on a four-point scale (i.e., social action, looking at the tester's face, make eye contact, and a verbal response). Scores are between 0 to 38.
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Title
Change in gross-motor performance scores
Description
The fine and gross motor coordination subtests of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOTMP-2) are a standardized and normed measure of gross and fine motor coordination. BOTMP-2 provides a raw, standard, and percentile scores. BOTMP-2 has eight subtests (running speed and agility, balance, bilateral coordination, strength, upper-limb coordination, response speed, visual-motor control, and upper-limb speed and dexterity). Testers will administer a short form of BOTMP-2 as well as the subtests for balance, bilateral coordination, manual dexterity, strength, fine motor precision, and fine motor integration, and upper-limb coordination subtests. The test provides percentile score that range from 0-100.
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Title
Change in praxis errors
Description
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 subtests of postural praxis, and bilateral motor coordination subtest. The praxis subtests will examine a child's ability to generalize the imitation skills to novel actions involved in the SIPT praxis subtests. 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.
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Title
Change in movement quality and prosocial behaviors
Description
In the structured play task, the testers will assess a child's ability to engage in prosocial behaviors as well as task-specific upper and lower-limb gross motor coordination skills. First, the tester will pretend to need help opening a tube or in collecting dropped items to see if the participating child will assist in opening or cleaning up of blocks. Next, the testers will perform multiple object control and locomotor skills consistent with the musical activities practiced during the training weeks. The test includes ball skills such as throwing, catching, dribbling, as well as locomotor skills of jump, hop, gallop, etc. developed using the items from the Test of Gross Motor Development-2nd edition (TGMD-2). Two trials of each action will be recorded. This task includes raw, standard, and percentile scores. Higher scores indicate better performance and range from 0-100.
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Secondary Outcome Measure Information:
Title
Change in distance covered during walking
Description
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.
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Title
Changes in time taken to complete the task
Description
The Timed-Up & Go test (TUG) test 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.
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Title
Developmental Coordination Disorder-Questionnaire
Description
Motor coordination questionnaire
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Title
Sensory Processing Measure (SPM)
Description
SPM measures changes in social participation as well as other sensory-motor preferences across intervention.
Time Frame
Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
Other Pre-specified Outcome Measures:
Title
Measures social communication delay
Description
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.
Time Frame
In the screening phase after initial contact with researchers
Title
Measures level of functioning in multiple domains
Description
The Vineland Adaptive Behavioral Scales (VABS) is a 20-minute parent questionnaire/interview that 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 provide us information on level of functioning across various developmental domains. Children with ASD will complete this measure. 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.
Time Frame
In the baseline period
Title
Diagnoses autism symptoms and their severity
Description
Autism Diagnostic Interview - Revised
Time Frame
Within 1 year from study participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with Autism Spectrum Disorder (ASD) between 6 and 14 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anjana Bhat, PhD
Phone
4435238680
Email
abhat@udel.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lavonne Sumler, MS
Phone
302-831-0216
Email
lsumler@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjana N Bhat, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anjana Narayan Bhat, PhD
Phone
443-523-8680
Email
abhat@udel.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Play on Social and Motor Skills of Children With ASD
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