NCT05131347

Brief Summary

The study will be a randomized controlled trial, which will aim to establish the appropriate and feasible content of the planned motor intervention program. A sample of 30 young children with ASD (4 to 5 years old) will be randomly assigned to treatment and control groups. Children in the treatment group will receive a 8-week motor skill intervention program. Children in the control group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration. Outcome measurements will consist of the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition Brief Form and Vineland Adaptive Behavior Scales-Third Edition. A two-factor mixed design ANOVA will be conducted to compare pre- and post-tests differences in the treatment and control groups. The findings of the proposed study will be useful for occupational therapists and clinicians to assist caregivers in implementing the intervention program and will contribute to knowledge regarding the effects of motor intervention program on increasing the motor skills of young children with ASD in Taiwan. Practitioners can design a standard treatment manual and provide information for implementing the motor intervention program. The expected results will help clinicians apply empirical knowledge to provide and promote the health and development of young children with ASD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

May 6, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2024

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2.5 years

First QC Date

October 28, 2021

Last Update Submit

May 26, 2025

Conditions

Keywords

autism spectrum disordermotor skillsadaptive functions

Outcome Measures

Primary Outcomes (2)

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

    The Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form uses a subtest and composite structure that highlights motor performance in the broad functional areas of stability, mobility, strength, coordination, and object manipulation. Scale scores (mean = 15, standard deviation = 5), confidence intervals, age equivalents, and descriptive categories are used to describe subtest performance. Standard scores (mean = 50, standard deviation = 10), confidence intervals, percentile ranks, and descriptive categories are used to describe motor performance. The higher the scores are, the better performance the children achieve.

    8 weeks

  • Vineland Adaptive Behavior Scales-Third Edition

    The Vineland Adaptive Behavior Scales-Third Edition (VABS-3) comprises four domains, that is, communication, daily living skills, socialization and motor skills, for assessing adaptive functioning in children aged 3 to 12 years old. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.

    8 weeks

Study Arms (2)

motor intervention

EXPERIMENTAL

Children in the motor intervention group will receive a 8-week motor intervention program. Each week will be of 1.5-hour duration.

Behavioral: motor intervention

cognitive intervention

ACTIVE COMPARATOR

Children in the cognitive intervention group will receive a 8-week cognitive training program. Each week will be of 1.5-hour duration.

Behavioral: cognitive intervention

Interventions

Children in the motor intervention group will receive motor skills training based on motor learning theory. Movement activities include playing on trampoline and tilt board, walking on knees, toes and heels, creeping and crawling under different obstacles, jumping forward and backward, driving scooter board, playing balance devices, hopping, and visual motor coordinated movement. These activities are designed from easy to complex.

motor intervention

Children in the cognitive intervention group will receive cognitive training. The activities consist of 12 exercises with progressive cognitive demands at 10 levels to improve cognitive functions such as attention, cognitive flexibility, inhibitory control, and working memory.

cognitive intervention

Eligibility Criteria

Age4 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosed with ASD by registered pediatric psychiatrists according to the Diagnostic and Statistical Manual-5th Edition
  • aged 48 to 71 months old
  • had no sensory impairments, such as visual or hearing impairments

You may not qualify if:

  • diagnosed with additional diseases, comorbidities, or presence of other disorders, such as epilepsy, attention deficit hyperactivity disorder (ADHD), or Fragile X syndrome
  • children with physical disabilities caused by head injuries, or neurological disorders
  • the inability to follow researcher's instructions and complete the research procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

Related Publications (1)

  • Alsaedi RH. An Assessment of the Motor Performance Skills of Children with Autism Spectrum Disorder in the Gulf Region. Brain Sci. 2020 Sep 3;10(9):607. doi: 10.3390/brainsci10090607.

    PMID: 32899306BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Ling-Yi Lin, ScD

    National Cheng Kung University

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 23, 2021

Study Start

May 6, 2022

Primary Completion

November 13, 2024

Study Completion

November 13, 2024

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations