Clinical trial NCT05131347: Effects of Motor Skill Occupational Therapy Intervention ON ASD (Motion ASD)
Official title: Effects of a Motor Intervention Program on Motor Skills and Adaptive Functions for Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: autism spectrum disorder
motor skills
adaptive functions
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Introduction: Preschool children with autism spectrum disorder may have motor difficulties in performing daily activities. Therefore, effective and economical interventions are very important to support them. However, the empirical evidence was still weak due to poor research designs and little research was comprehensively investigated children's motor performance. Aim: This study will implement a dose-matched control group and comprehensive measurements to examine if the motor skill intervention program will improve children's motor performance. Hypotheses: The hypothesis will be that the better improvements would show in the motor skill intervention program than those in the cognitive training program. Method: Thirty preschool children with autism spectrum disorder will be recruited and randomly assigned to either the motor skill intervention program group or the cognitive training program group after pretest phase. Both groups will conduct 8-week intervention programs and be assessed after interventions. Children's motor performance will be assessed by the Bruininks-Oseretsky Test of Motor Proficiency-Second Edition Brief Form and the Vineland Adaptive Behavior Scales.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Bruininks-Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) Brief Form
timeFrame: 8 weeks
measure: Vineland Adaptive Behavior Scales-Third Edition
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Ling-Yi Lin, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.