About this trial
Studies have shown that children with ASD simultaneously have deficits in overall executive function and impairments in basic motor skills, which have a negative impact on cognitive and social all-round development. In recent years, intervention measures for the motor skills of children with ASD have gradually developed. However, based on the existing literature, there is still a lack of recommendations for sports training at present. The sustained effect of exercise intervention training on the core symptoms of ASD remains unclear. In terms of executive function, there are relatively few studies on the executive function of preschool children. The impact of motor training on working memory in school-aged children is still inconsistent. Furthermore, the connection characteristics of different brain regions in children with ASD after physical training remain unclear. This study will include 70 children with ASD aged 3 to 9 years for a multicenter randomized controlled trial (RCT). These children will be randomly assigned to the intervention group (Child-Parent-Trainer program) and the control group (regular physical education program) for 12 weeks, 5 days/week, 60 minutes/day training. Children's core symptoms, executive function, child/family quality of life, and functional near-infrared spectroscopy (fNIRS) were assessed at baseline (training weeks 0) and endpoints (training weeks 13 and 17), respectively. To verify the improvement effect of this exercise program on the autism severity, core symptoms and executive functions of children with ASD, as well as its impact on family quality of life. Furthermore, through fNIRS for monitoring changes in brain function, the potential neural physiological mechanisms will be explored.
Eligibility criteria
Qualifiers
Age: 3-9 years old.
Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for ASD, And hold a certificate of ASD diagnosis issued by a Tertiary A hospital.
Borderline/normal intelligence or mild intellectual disability.
No serious behavior or emotional problems.
Disqualifiers
Vision/ hearing disorders, schizophrenia, emotional disorders, mental retardation, Rett syndrome and other developmental disorders.
Medical conditions that limit the ability to be physically active, such as asthma, epilepsy, heart disease, and the acute phase after a fracture.
History of head trauma, physical disability, major organ disease, or severe musculoskeletal injury in the past two years.
Those who have participated in physical exercise regularly within the last 6 months.
Trial design
Treatments tested in this trial
- The Child-Parent- Trainer exercise program
- The regular physical training
Treatment groups
Sponsors and collaborators
Chen Li
Lead sponsor
Children's Hospital of Chongqing Medical University
Sponsor institution
Gansu Provincial Maternal and Child Health Care Hospital
Collaborator