Trial Outcomes & Findings for The Effect of Play on Social and Motor Skills of Children With ASD (NCT NCT04258254)

NCT ID: NCT04258254

Last Updated: 2023-11-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test
• Results posted on: 2023-11-21

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	15	16	15
Overall Study COMPLETED	15	15	15
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

The Effect of Play on Social and Motor Skills of Children With ASD

Baseline characteristics by cohort

Measure	Multimodal n=15 Participants 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 n=16 Participants 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 n=15 Participants 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.	Total n=46 Participants Total of all reporting groups
Age, Continuous	9.5 years STANDARD_DEVIATION 0.6 • n=5 Participants	9.1 years STANDARD_DEVIATION 0.6 • n=7 Participants	8.4 years STANDARD_DEVIATION 0.6 • n=5 Participants	9 years STANDARD_DEVIATION 0.6 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	37 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	10 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants
Race/Ethnicity, Customized African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Vineland Adaptive Behavior Scales, ABC Score	71.4 units on a scale STANDARD_DEVIATION 3 • n=5 Participants	70.4 units on a scale STANDARD_DEVIATION 2.9 • n=7 Participants	75.5 units on a scale STANDARD_DEVIATION 2.8 • n=5 Participants	72 units on a scale STANDARD_DEVIATION 2.9 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

Population: Standard composite scores (Mean=50, SD=10) for body coordination, strength \& agility, manual coordination and fine motor coordination.

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.

Outcome measures

Measure	Multimodal n=15 Participants 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 n=15 Participants 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 n=15 Participants 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.
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Posttest BOT Body Coordination	40.9 score on a scale BOT-2 Standard Error 2.8	44.0 score on a scale BOT-2 Standard Error 3.8	37.7 score on a scale BOT-2 Standard Error 1.9
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Follow-up BOT Body coordination	40.8 score on a scale BOT-2 Standard Error 2.5	44 score on a scale BOT-2 Standard Error 3.7	37 score on a scale BOT-2 Standard Error 1.8
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Pretest BOT Strength&Agility	32.3 score on a scale BOT-2 Standard Error 2.2	37.4 score on a scale BOT-2 Standard Error 2.9	33.3 score on a scale BOT-2 Standard Error 1.6
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Pretest BOT body coordination	36.4 score on a scale BOT-2 Standard Error 2.0	36.9 score on a scale BOT-2 Standard Error 3.6	36.5 score on a scale BOT-2 Standard Error 1.9
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Posttest BOT Strength & Agility	34.5 score on a scale BOT-2 Standard Error 2.7	42.5 score on a scale BOT-2 Standard Error 3.0	34.4 score on a scale BOT-2 Standard Error 1.9
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Follow-up BOT Strength & Agility	33 score on a scale BOT-2 Standard Error 2.3	43 score on a scale BOT-2 Standard Error 3.1	33.4 score on a scale BOT-2 Standard Error 1.7
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Pretest BOT Manual Coordination	29.8 score on a scale BOT-2 Standard Error 1.4	33.3 score on a scale BOT-2 Standard Error 1.5	33.0 score on a scale BOT-2 Standard Error 1.5
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Posttest BOT Manual Coordination	31.1 score on a scale BOT-2 Standard Error 2.3	34.5 score on a scale BOT-2 Standard Error 1.4	33.3 score on a scale BOT-2 Standard Error 1.6
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Follow-Up BOT Manual Dexterity	32 score on a scale BOT-2 Standard Error 2.0	33 score on a scale BOT-2 Standard Error 1.2	34 score on a scale BOT-2 Standard Error 1.7
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Pretest BOT Fine-manual control	36.4 score on a scale BOT-2 Standard Error 2.7	40.7 score on a scale BOT-2 Standard Error 3.1	36.4 score on a scale BOT-2 Standard Error 2.4
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Posttest BOT Fine manual control	36.1 score on a scale BOT-2 Standard Error 2.8	41.4 score on a scale BOT-2 Standard Error 3.4	41.5 score on a scale BOT-2 Standard Error 2.5
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Follow-up BOT Fine manual control	37 score on a scale BOT-2 Standard Error 2.5	41 score on a scale BOT-2 Standard Error 2.9	42.3 score on a scale BOT-2 Standard Error 2.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Multimodal n=15 Participants 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 n=15 Participants 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 n=15 Participants 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.
Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error Pretest Total Praxis Error	21.5 number of errors Standard Error 1.5	23.1 number of errors Standard Error 1.8	22.4 number of errors Standard Error 2.0
Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error Posttest Total Praxis Error	17.6 number of errors Standard Error 1.5	20.1 number of errors Standard Error 1.6	17 number of errors Standard Error 2.2
Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error Follow-Up Total Praxis Error	15.9 number of errors Standard Error 2.3	18.7 number of errors Standard Error 1.9	18.1 number of errors Standard Error 1.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Multimodal n=9 Participants 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 n=14 Participants 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 n=13 Participants 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.
Flanker Task of Executive Functioning (EF) Pretest Incongruent condition, Flanker Reaction Time	3.6 Reaction time in msec Standard Error 0.9	2.4 Reaction time in msec Standard Error 0.5	2.1 Reaction time in msec Standard Error 0.5
Flanker Task of Executive Functioning (EF) Followup Incongruent Flanker Reaction Time	2.4 Reaction time in msec Standard Error 0.6	2.0 Reaction time in msec Standard Error 0.6	1.9 Reaction time in msec Standard Error 0.5
Flanker Task of Executive Functioning (EF) Posttest Incongruent condition, Flanker Reaction Time	2.4 Reaction time in msec Standard Error 0.65	1.8 Reaction time in msec Standard Error 0.6	1.9 Reaction time in msec Standard Error 0.6

PRIMARY outcome

Timeframe: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

Population: Number of errors.

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.

Outcome measures

Measure	Multimodal n=15 Participants 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 n=15 Participants 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 n=15 Participants 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.
Synchrony Errors During the Rhythmic Synchrony Task Pretest Social Synchrony error #	1.9 Number of erroneous cycles Standard Error 0.1	1.9 Number of erroneous cycles Standard Error 0.2	2.1 Number of erroneous cycles Standard Error 1.3
Synchrony Errors During the Rhythmic Synchrony Task Posttest Social Synchrony error #	1.3 Number of erroneous cycles Standard Error 0.2	1.4 Number of erroneous cycles Standard Error 0.2	2 Number of erroneous cycles Standard Error 0.1
Synchrony Errors During the Rhythmic Synchrony Task Follow-up Social Synchrony error #	1.5 Number of erroneous cycles Standard Error 0.2	1.6 Number of erroneous cycles Standard Error 0.2	1.7 Number of erroneous cycles Standard Error 0.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Multimodal n=15 Participants 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 n=15 Participants 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 n=15 Participants 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.
Number of Prosocial Behaviors Pretest Prosocial Behaviors #	8.4 Number of prosocial behaviors Standard Error 0.37	9.3 Number of prosocial behaviors Standard Error 0.3	7.4 Number of prosocial behaviors Standard Error 0.8
Number of Prosocial Behaviors Posttest Prosocial Behaviors #	9 Number of prosocial behaviors Standard Error 0.37	8.6 Number of prosocial behaviors Standard Error 0.4	8.9 Number of prosocial behaviors Standard Error 0.4
Number of Prosocial Behaviors Follow-up Prosocial Behaviors #	8.8 Number of prosocial behaviors Standard Error 0.4	8.3 Number of prosocial behaviors Standard Error 0.6	7.9 Number of prosocial behaviors Standard Error 0.5

SECONDARY outcome

Timeframe: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

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.

Outcome measures

Measure	Multimodal n=14 Participants 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 n=14 Participants 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 n=14 Participants 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.
2-Minute Walk Test Pretest 2MWT distance	481.9 distance covered in feet Standard Error 57.8	416 distance covered in feet Standard Error 37.6	471.3 distance covered in feet Standard Error 26.9
2-Minute Walk Test Posttest 2MWT distance	496.9 distance covered in feet Standard Error 40.2	478.9 distance covered in feet Standard Error 34.8	497.1 distance covered in feet Standard Error 24.1
2-Minute Walk Test Follow-up 2MWT distance	405.9 distance covered in feet Standard Error 23.6	469.4 distance covered in feet Standard Error 38.9	449.4 distance covered in feet Standard Error 37

SECONDARY outcome

Timeframe: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

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.

Outcome measures

Measure	Multimodal n=14 Participants 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 n=14 Participants 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 n=14 Participants 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.
Timed-Up & Go Test (TUG) Pretest TUG score	7.1 Time taken in seconds Standard Error 0.6	6.3 Time taken in seconds Standard Error 0.5	7.3 Time taken in seconds Standard Error 0.5
Timed-Up & Go Test (TUG) Posttest TUG score	6.1 Time taken in seconds Standard Error 0.4	6.3 Time taken in seconds Standard Error 0.4	7.3 Time taken in seconds Standard Error 0.5
Timed-Up & Go Test (TUG) Follow-up TUG score	6.2 Time taken in seconds Standard Error 0.3	5.5 Time taken in seconds Standard Error 0.3	6.6 Time taken in seconds Standard Error 0.4

SECONDARY outcome

Timeframe: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

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.

Outcome measures

Measure	Multimodal n=15 Participants 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 n=15 Participants 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 n=15 Participants 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.
Developmental Coordination Disorder-Questionnaire Pretest Total DCD-Q score	41.3 score on a scale Standard Error 2.7	44.3 score on a scale Standard Error 2.6	41.2 score on a scale Standard Error 1.9
Developmental Coordination Disorder-Questionnaire Posttest Total DCD-Q score	42.9 score on a scale Standard Error 2.7	48.9 score on a scale Standard Error 2.6	44.3 score on a scale Standard Error 1.8
Developmental Coordination Disorder-Questionnaire Follow-up Total DCD-Q score	42.8 score on a scale Standard Error 2.3	47.8 score on a scale Standard Error 3.1	44.1 score on a scale Standard Error 1.9

SECONDARY outcome

Timeframe: Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test

Population: T score

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.

Outcome measures

Measure	Multimodal n=14 Participants 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 n=14 Participants 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 n=14 Participants 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.
Sensory Processing Measure (SPM) Pretest SPM T score	67.4 score on a scale Standard Error 1.7	68.9 score on a scale Standard Error 1.4	65 score on a scale Standard Error 1.6
Sensory Processing Measure (SPM) Post-test SPM T score	66.9 score on a scale Standard Error 1.9	66.3 score on a scale Standard Error 1.4	64.9 score on a scale Standard Error 1.7
Sensory Processing Measure (SPM) Follow-up test SPM T score	67 score on a scale Standard Error 1.8	65.9 score on a scale Standard Error 1.3	64.5 score on a scale Standard Error 1.9

OTHER_PRE_SPECIFIED outcome

Timeframe: In the screening phase after initial contact with researchers

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.

Outcome measures

Measure	Multimodal n=15 Participants 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 n=15 Participants 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 n=15 Participants 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.
Social Communication Questionnaire (SCQ)	18 Total score Standard Error 1.8	13 Total score Standard Error 1.5	13.1 Total score Standard Error 1

OTHER_PRE_SPECIFIED outcome

Timeframe: In the baseline period

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.

Outcome measures

Measure	Multimodal n=14 Participants 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 n=14 Participants 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 n=14 Participants 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.
Vineland Adaptive Behavioral Scales (VABS)	71 Standard score Standard Error 2.9	77.1 Standard score Standard Error 2.9	75.5 Standard score Standard Error 2.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Only completed once at pretest.

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.

Outcome measures

Measure	Multimodal n=14 Participants 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 n=14 Participants 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 n=14 Participants 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.
Social Responsiveness Scale-Second Edition (SRS-2)	78 score on a scale Standard Error 2.9	70 score on a scale Standard Error 2	74.1 score on a scale Standard Error 1.5

Adverse Events

Multimodal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Movement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anjana Bhat, Study PI

University of Delaware

Phone: 4435238680

Email: abhat@udel.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place