An interventional study of The Child-Parent- Trainer exercise program and The regular physical training in Autism Spectrum Disorder, sponsored by Chen Li. Not yet recruiting at 1 site in China. Open to participants aged 3 Years to 9 Years. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Chen Li · Not applicable, Interventional, and Treatment
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.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's planned enrollment of 70 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
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Exclusion Criteria:
The intervention group received systematic exercise training (the Child-Parent- Trainer exercise program) for 12 weeks (5 days/week, 60 minutes/day).
Procedure: The Child-Parent- Trainer exercise program
The control group received regular physical training courses for 12 weeks (5 days/week, 60 minutes/day).
Procedure: The regular physical training
The Child-Parent-Trainer exercise program is a 12-week exercise training program, which is based on the sensory and cognitive needs of children with ASD, multiple game forms are integrated to form a multi-sensory intervention model. The exercise program is developed according to the types of exercise recommended in the Exercise Guidelines for Preschool Children of China, including the development of basic motor skills, such as physical movement, posture control, object control; development of important physical qualities, such as agility, balance, coordination. The training program for different age group consists of physical movement items, object control items and limb coordination items. The exercise intensity is moderate.
The regular physical training courses will last for 12 weeks. It is training in motor skills and fine motor skills. The items include passing the ball, lifting small dumbbells, running, handicrafts, etc. There is no requirement for the intensity of the exercise.
The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2
The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2 Description: The Autism Diagnostic Observation Schedule-2 (ADOS-2) is adopted to assess the changes in the degree of ASD disorder. The Autism Diagnostic Observation Schedule-2 (ADOS-2) is a standardized observational assessment. The assessment includes abilities in four areas: social interaction, stereotypical behavior, verbal communication, emotion, and abnormal behavior. Children in the our study were administered a module 1 for children with little or no phrase speech or Module 2, for children who use phrase speech but are not yet fluent. Standardized ADOS scores in the domains of social affect (SA) and restricted repetitive behaviors (RRB) were calculated as indicators of ASD severity.
Time frame: Training weeks 0, 13, and 17.
The changes in degree of ASD disorder by Childhood Autism Rating Scale (CARS)
The Childhood Autism Rating Scale (CARS) are adopted to assess the changes in the degree of ASD disorder. The Childhood Autism Rating Scale (CARS) serves as an assessment indicator for the improvement of ASD symptoms. The scale consists of 15 items including relationship with people, imitation, emotional response, etc. The evaluation criteria for therapeutic effect are as follows: a CARS score reduction of less than or equal to 10 is considered effective, a CARS score reduction of 5 to 9 is considered effective, and a score reduction of less than 5 is considered ineffective.
Time frame: Training weeks 0, 13, and 17.
The changes of executive functions
The preschool BRIEF is consisted of 63 entries and divided into 5 factors and 3 dimensions. The 5 factors are inhibition, conversion, affective control, working memory, and organizational planning. The 3 dimensions are the inhibitory self-regulation index (including inhibition and affective control), cognitive flexibility index (including conversion and affective control) and metacognitive index (including working memory and organizational planning). School-age children BRIEF, consisting of 86 entries, is divided into 2 dimensions: behavior management index (including 3 factors of inhibition, conversion and emotional control) and metacognitive function index (including 5 factors of task initiation, working memory, planning, organization and monitoring). The higher the score, the more impaired the executive function. We examine the score of BRIEF to reflect changes in executive function before and after training.
Time frame: Training weeks 0, 13, and 17.
The changes of brain function detection indicators
We monitor cerebral hemodynamic changes through the fNIRS device. The Go/No-Go paradigm task was performed on children over 4 years old. This paradigm consists of two main parts, GO and GO /No-Go. During the GO task, participants are shown pictures of two animals (a giraffe and a lion) and instructed to quickly press the space bar when they see an animal picture. During the GO /No-Go task, pictures of two animals (a tiger and an elephant) are shown at random, and children are asked to quickly press the space bar when they see an elephant. To record correct rate and response time for analysis. All the subjects will undergo resting-state functional connectivity tests. We will compare the differences in fNIRS features before and after training.
Time frame: Training weeks 0, 13, and 17.
The changes of children's life quality by Child Eating Behavior Questionnaire (CEBQ)
The dietary Behavior status of children was evaluated through the Child Eating Behavior Questionnaire (CEBQ). It includes 8 subscales such as food response, emotional overeating, and food preferences, covering 35 items. The answer score ranges from 1 to 5. If at least 80% of the items have been completed, the average value of each sub-scale will be calculated.
Time frame: Training weeks 0, 13, and 17.
The changes of children's life quality by Children's Sleep Habits Questionnaire (CSHQ)
The children's sleep habits questionnaire includes eight behaviors such as pre-sleep resistance, delayed sleep initiation, and sleep duration. A total score greater than 41 points indicates the presence of sleep disorders.
Time frame: Training weeks 0, 13, and 17.
The changes of parents' life quality by Parenting Stress Index (PSI)
The Parenting Stress Index was used to assess the mental stress that parents experience during the process of raising children. This scale consists of 36 items and covers 3 dimensions, including parenting distress, dysfunctional parent-child interaction, and children in difficulty. It is scored on a 5-point scale, with a higher score indicating greater parenting pressure. People with a total score of ≥P90 are considered to be under high pressure.
Time frame: Training weeks 0, 13, and 17.
The changes in heart rate
Heart rate (or pulse rate) is the frequency of the heartbeat measured by the number of contractions (beats) of the heart per minute (bpm). When the children are doing aerobic exercise, we monitor the changes of heart rate and analysis.
Time frame: At exercise training.
Plan to share: No — Data is confidential during the study.
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