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

NCT04258254 | Completed Results

• 2 other identifiers: 1539736-13P20GM103446-19S1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Movement; Play; Social; Communication; Motor

Outcome Measures

Primary Outcomes (5)

• 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.

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

• Praxis Subtests of the Sensory Integration and Praxis Testing (SIPT) - Postural Praxis Error

  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.

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

• Flanker Task of Executive Functioning (EF)

  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.

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

• Synchrony Errors During the Rhythmic Synchrony Task

  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.

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

• Number of Prosocial Behaviors

  In a structured play task, the tester assessed a child's ability to engage in prosocial behaviors across multiple helping bids to engage the child in helping behaviors (e.g., clean up of pennies, peg, blocks, cards, and dropped pencils). There are no T or standard scores available for this behavioral measure (not a standardized test). Higher number indicates more prosocial behaviors by the child during the helping bids.

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

Secondary Outcomes (4)

• 2-Minute Walk Test

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

• 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

• Developmental Coordination Disorder-Questionnaire

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

• Sensory Processing Measure (SPM)

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

Other Outcomes (3)

• Social Communication Questionnaire (SCQ)

  In the screening phase after initial contact with researchers

• Vineland Adaptive Behavioral Scales (VABS)

  In the baseline period

• Social Responsiveness Scale-Second Edition (SRS-2)

  Only completed once at pretest.

Study Arms (3)

Multimodal

EXPERIMENTAL

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.

Behavioral: Multimodal

General Movement

ACTIVE COMPARATOR

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.

Behavioral: General

Standard of Care

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care

Interventions

Multimodal BEHAVIORAL

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.

Also known as: Coordination/Balance

Multimodal

General BEHAVIORAL

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.

Also known as: Physical Activity, Strength, Endurance

General Movement

Standard of Care BEHAVIORAL

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.

Also known as: Sedentary or Seated Play

Standard of Care

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with Autism Spectrum Disorder (ASD) between 5 and 15 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Delaware: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

Related Publications (1)

• Su WC, Cleffi C, Srinivasan S, Bhat A. A Pilot Study Comparing the Efficacy, Fidelity, Acceptability, and Feasibility of Telehealth and Face-to-Face Creative Movement Interventions in Children with Autism Spectrum Disorder. Telemed Rep. 2024 Mar 21;5(1):67-77. doi: 10.1089/tmr.2023.0061. eCollection 2024.

  PMID: 38558955 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Communication

Interventions

Combined Modality Therapy; Exercise; Standard of Care

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Anjana Bhat, Study PI
• Organization: University of Delaware

abhat@udel.edu

4435238680

Study Officials

• Anjana N Bhat, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: February 6, 2020
• Study Start: June 4, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 21, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)