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

A Multisystem, Multimodal Intervention for Children With ASD

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04258254

Enrollment

Registered

2020-02-06

Start date

2020-06-04

Completion date

2022-05-31

Last updated

2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Movement, Play, Social, Communication, Motor

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

46 children with ASD between 5 and 15 years of age will be randomly assigned to the multimodal or general play or seated play groups. Each child will participate in 9 testing sessions (4 pretests, 3 posttests, and 3, 2-month follow-ups) and 8 weeks of multimodal or general intervention between pre-tests and post-tests. In the 8-week phase between the pre- and post-tests, each child will complete group-specific intervention-related activities with the expert clinician twice per week via telehealth or face-to-face interactions. Each session will last for around 1-1.5 hours. If the study aims are achieved, the investigators will validate the use of cortical markers as a treatment response measure. Findings from this research will offer evidence for the use of various movement interventions to promote motor, social communication, and cognitive skills in school-age children with ASD.

Interventions

BEHAVIORALMultimodal

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.

BEHAVIORALGeneral

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.

BEHAVIORALStandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

5 Years to 15 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Prosocial Behaviors	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.
Flanker Task of Executive Functioning (EF)	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.
Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)	Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test	The 3 gross motor coordination and 1 fine manual control composite of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) were administered as a measure of gross and fine motor coordination at each time point. BOT-2 standard scores will be reported for each composite: (i) body coordination composite comprises of balance and bilateral coordination, (ii) the strength/agility composite is comprised of running speed and agility, (iii) upper-limb coordination composite is comprised of upper-limb coordination and manual dexterity, and (iv) the fine manual control composite is comprised of fine motor precision and integration. Standard composite scores on the BOT-2 have a Mean=50 and a standard deviation (SD)=10 for body coordination, strength & agility, manual coordination and fine motor coordination composite domains. Higher standard scores represent a better outcome. Note there are no T-scores as such for BOT-2; the term often used is a standard BOT composite score.
Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error	Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test	The praxis subtests of Sensory Integration and Praxis Testing (SIPT) are standardized and normed measures of examining motor coordination, sensory integration, and praxis. Specifically, the investigators are planning to use items from subtest of postural praxis subtest. The praxis subtests will examine a child's ability to generalize the imitation skills to novel actions involved in the SIPT postural praxis subtest. This test provides the number of errors per action copied and a total number of errors. There is no fixed range as such but the scores could range from 0 to 100. There are no T or standard scores available for this subtest. Higher number of errors indicates a poor outcome.
Synchrony Errors During the Rhythmic Synchrony Task	Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test	In the rhythmic synchrony task children will perform social drumming (i.e., move in synchrony with an adult as the child follows the adult's drumming motions). Synchrony errors were coded when the child was not matching with the adult for each movement cycle. Higher number of errors indicate a poor outcome. This was an experimental paradigm, and not a standardize measure. Hence, there are no T-scores to report.

Secondary

Measure	Time frame	Description
Sensory Processing Measure (SPM)	Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test	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.
2-Minute Walk Test	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.
Timed-Up & Go Test (TUG)	Baseline to Post-test after 8 weeks of intervention, Baseline to Follow-up testing after 8 weeks from post-test	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.
Developmental Coordination Disorder-Questionnaire	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.

Other

Measure	Time frame	Description
Social Communication Questionnaire (SCQ)	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.
Social Responsiveness Scale-Second Edition (SRS-2)	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.
Vineland Adaptive Behavioral Scales (VABS)	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	15
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.	16
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.	15
Total	46

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Withdrawal by Subject	0	1	0

Baseline characteristics

Characteristic	General Movement	Standard of Care	Multimodal	Total
Age, Continuous	9.1 years STANDARD_DEVIATION 0.6	8.4 years STANDARD_DEVIATION 0.6	9.5 years STANDARD_DEVIATION 0.6	9 years STANDARD_DEVIATION 0.6
Race/Ethnicity, Customized African American	2 Participants	5 Participants	3 Participants	10 Participants
Race/Ethnicity, Customized Asian	7 Participants	2 Participants	2 Participants	11 Participants
Race/Ethnicity, Customized Caucasian	7 Participants	8 Participants	10 Participants	25 Participants
Sex: Female, Male Female	4 Participants	2 Participants	3 Participants	9 Participants
Sex: Female, Male Male	12 Participants	13 Participants	12 Participants	37 Participants
Vineland Adaptive Behavior Scales, ABC Score	70.4 units on a scale STANDARD_DEVIATION 2.9	75.5 units on a scale STANDARD_DEVIATION 2.8	71.4 units on a scale STANDARD_DEVIATION 3	72 units on a scale STANDARD_DEVIATION 2.9

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 16	0 / 15
other Total, other adverse events	0 / 15	0 / 16	0 / 15
serious Total, serious adverse events	0 / 15	0 / 16	0 / 15

Outcome results

Primary

Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2)

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.