Autism Spectrum DisorderNCT07104708
Effects of Systematic Exercise Training on Core Symptoms, Executive Function and Brain Function in Children With ASD
A study testing The Child-Parent- Trainer exercise program and The regular physical training in people with Autism Spectrum Disorder, run by Chen Li at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- The Child-Parent- Trainer exercise program and The regular physical training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Able to simply ask and answer questions.
- Be able to proactively express the need to use the toilet.
- There are no physical impairments that affected participation in physical activities, and participants are able to cooperate to complete the intervention.
- Informed parental consent.
Who cannot join
- 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.
- Participants who changed treatment intervention midway after inclusion.
- Unable to cooperate with persistent completion of intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Growth, Development and Mental health of Children and Adolescence Center
Chongqing, Chongqing Municipality, 400014
Li Chen, MD, 136 7762 0103 ext. +86, chenli2012@126.com
About this study
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.
Read the detailed description
- Procedures. The children in the group are randomly divided into a intervention group and a control group. The children will be trained for 12 weeks (5 days/week, 60 minutes/day) and the children will be evaluated for the severity of autism, core symptoms, executive function, child/family quality of life, and fNIRS at training weeks 0, 13, and 17, respectively.
- Demographic questionnaire and clinical data. The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, heart rate. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis and comorbid conditions.
- Sample size. This study is a randomized controlled trial. The proposed sample size is based on using the sample size formula, which compares the two sample means, . Where, tα is the standard normal difference corresponding to the level, taking α=0.05 and tα=1.96; tβ is the u value corresponding to the probability β of type II error, taking β=0.10 and tβ=1.28; σ is the estimate of the population standard deviation; δ is the allowable error, the difference between two population means. According to literature review, taking the adjustment ability in executive function as the main observation index, it is calculated that δ/σ =0.84. The sample size of intervention group and control group was 30 children, respectively. Considering the sample loss rate of 15%, the two groups are finally determined to be 35 children respectively.
- Statistical analysis. SPSS 25.0 software (SPSS Inc) was used for statistical analysis for the scale data, including core symptoms and executive function, and the data were expressed as (M±SD). The scales scores and demographic variables of both groups of children will be compared using independent samples t-tests. Differences between baseline and 1 week and 1 month after exercise will be analysed using a repeated measures F-test. All statistical analyses were conducted with a statistical threshold P-value of <0.05. The data collected through fNIRS will be performed via NirSpark analysis software. The general linear model (GLM) will be applied to integrate task effects and assess activation in relevant brain regions. To analyze the rsFC of brain in children with ASD before and after the exercise intervention, the FC_NIRS toolbox is used.
- Ethical matters and data protection. The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
- Conditions
- Autism Spectrum Disorder
- Being tested
- The Child-Parent- Trainer exercise program, The regular physical training
- Keywords
- executive function, brain function, exercise training, Autism spectrum disorder
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Child-Parent- Trainer exercise programProcedure or surgery
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 trainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group received systematic exercise training (the Child-Parent- Trainer exercise program) for 12 weeks (5 days/week, 60 minutes/day). Receives: Procedure: The Child-Parent- Trainer exercise program |
| Control group | Active comparator | The control group received regular physical training courses for 12 weeks (5 days/week, 60 minutes/day). Receives: Procedure: The regular physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Training weeks 0, 13, and 17.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At exercise training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The children are randomly divided into a intervention group and a control group. On the basis of the basic ASD rehabilitation training, the children will be trained for 12 weeks (5 days/week, 60 minutes/day). The intervention group received systematic exercise training (the Child-Parent- Trainer exercise program), while the control group received regular physical training courses.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Li
- Sponsor type
- University, hospital or other
- Collaborators
- Gansu Provincial Maternal and Child Health Care Hospital
- Responsible party
- Sponsor-investigator, Chen Li, Children's Hospital of Chongqing Medical University
- Investigators
- Li Chen, doctor, Study director, Children's Hospital of Chongqing Medical Universityyu T Li, Doctor, Study chair, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104708
- Sponsor's protocol ID
- SETA
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is confidential during the study.
Publications
Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.
PubMed 30078460Xu G, Strathearn L, Liu B, O'Brien M, Kopelman TG, Zhu J, Snetselaar LG, Bao W. Prevalence and Treatment Patterns of Autism Spectrum Disorder in the United States, 2016. JAMA Pediatr. 2019 Feb 1;173(2):153-159. doi: 10.1001/jamapediatrics.2018.4208.
PubMed 30508021Demetriou EA, Lampit A, Quintana DS, Naismith SL, Song YJC, Pye JE, Hickie I, Guastella AJ. Autism spectrum disorders: a meta-analysis of executive function. Mol Psychiatry. 2018 May;23(5):1198-1204. doi: 10.1038/mp.2017.75. Epub 2017 Apr 25.
PubMed 28439105Lippi G, Mattiuzzi C, Sanchis-Gomar F. Updated overview on interplay between physical exercise, neurotrophins, and cognitive function in humans. J Sport Health Sci. 2020 Jan;9(1):74-81. doi: 10.1016/j.jshs.2019.07.012. Epub 2019 Sep 6.
PubMed 31921482Zampella CJ, Wang LAL, Haley M, Hutchinson AG, de Marchena A. Motor Skill Differences in Autism Spectrum Disorder: a Clinically Focused Review. Curr Psychiatry Rep. 2021 Aug 13;23(10):64. doi: 10.1007/s11920-021-01280-6.
PubMed 34387753Chan JS, Deng K, Yan JH. The effectiveness of physical activity interventions on communication and social functioning in autistic children and adolescents: A meta-analysis of controlled trials. Autism. 2021 May;25(4):874-886. doi: 10.1177/1362361320977645. Epub 2020 Dec 11.
PubMed 33307759Sandbank M, Bottema-Beutel K, Woynaroski T. Intervention Recommendations for Children With Autism in Light of a Changing Evidence Base. JAMA Pediatr. 2021 Apr 1;175(4):341-342. doi: 10.1001/jamapediatrics.2020.4730. No abstract available.
PubMed 33165523Jia M, Zhang J, Pan J, Hu F, Zhu Z. Benefits of exercise for children and adolescents with autism spectrum disorder: a systematic review and meta-analysis. Front Psychiatry. 2024 Oct 7;15:1462601. doi: 10.3389/fpsyt.2024.1462601. eCollection 2024.
PubMed 39435130Tao R, Yang Y, Wilson M, Chang JR, Liu C, Sit CHP. Comparative effectiveness of physical activity interventions on cognitive functions in children and adolescents with Neurodevelopmental Disorders: a systematic review and network meta-analysis of randomized controlled trials. Int J Behav Nutr Phys Act. 2025 Jan 13;22(1):6. doi: 10.1186/s12966-024-01702-7.
PubMed 39806448Chan AS, Sze SL, Siu NY, Lau EM, Cheung MC. A chinese mind-body exercise improves self-control of children with autism: a randomized controlled trial. PLoS One. 2013 Jul 10;8(7):e68184. doi: 10.1371/journal.pone.0068184. Print 2013.
PubMed 23874533Toscano CVA, Ferreira JP, Quinaud RT, Silva KMN, Carvalho HM, Gaspar JM. Exercise improves the social and behavioral skills of children and adolescent with autism spectrum disorders. Front Psychiatry. 2022 Dec 22;13:1027799. doi: 10.3389/fpsyt.2022.1027799. eCollection 2022.
PubMed 36620673Grospretre S, Ruffino C, Derguy C, Gueugneau N. Sport and Autism: What Do We Know so Far? A Review. Sports Med Open. 2024 Oct 3;10(1):107. doi: 10.1186/s40798-024-00765-x.
PubMed 39361117Zhang F, Roeyers H. Exploring brain functions in autism spectrum disorder: A systematic review on functional near-infrared spectroscopy (fNIRS) studies. Int J Psychophysiol. 2019 Mar;137:41-53. doi: 10.1016/j.ijpsycho.2019.01.003. Epub 2019 Jan 19.
PubMed 30664885Mazzoni A, Grove R, Eapen V, Lenroot RK, Bruggemann J. The promise of functional near-infrared spectroscopy in autism research: What do we know and where do we go? Soc Neurosci. 2019 Oct;14(5):505-518. doi: 10.1080/17470919.2018.1497701. Epub 2018 Jul 21.
PubMed 29985114Deng J, Lei T, Du X. Effects of sensory integration training on balance function and executive function in children with autism spectrum disorder: evidence from Footscan and fNIRS. Front Psychol. 2023 Oct 25;14:1269462. doi: 10.3389/fpsyg.2023.1269462. eCollection 2023.
PubMed 37946875
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Systematic Exercise Training on Core Symptoms, Executive Function and Brain Function in Children With ASD
- ClinicalTrials.gov ID
- NCT07104708
- Acronym / sponsor ID
- SETA
- Conditions
- Autism Spectrum Disorder
- Keywords
- executive function, brain function, exercise training, Autism spectrum disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chen LiUniversity, hospital or other
- Collaborators
- Gansu Provincial Maternal and Child Health Care Hospital
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Procedures. The children in the group are randomly divided into a intervention group and a control group. The children will be trained for 12 weeks (5 days/week, 60 minutes/day) and the children will be evaluated for the severity of autism, core symptoms, executive function, child/family quality of life, and fNIRS at training weeks 0, 13, and 17, respectively.
- Demographic questionnaire and clinical data. The demographic questionnaire is completed by the child's primary caregiver, detailing child's name, gender, date of birth, height, weight, heart rate. Clinical data will be ascertained from the medical records, including information about DSM-5 diagnosis and comorbid conditions.
- Sample size. This study is a randomized controlled trial. The proposed sample size is based on using the sample size formula, which compares the two sample means, . Where, tα is the standard normal difference corresponding to the level, taking α=0.05 and tα=1.96; tβ is the u value corresponding to the probability β of type II error, taking β=0.10 and tβ=1.28; σ is the estimate of the population standard deviation; δ is the allowable error, the difference between two population means. According to literature review, taking the adjustment ability in executive function as the main observation index, it is calculated that δ/σ =0.84. The sample size of intervention group and control group was 30 children, respectively. Considering the sample loss rate of 15%, the two groups are finally determined to be 35 children respectively.
- Statistical analysis. SPSS 25.0 software (SPSS Inc) was used for statistical analysis for the scale data, including core symptoms and executive function, and the data were expressed as (M±SD). The scales scores and demographic variables of both groups of children will be compared using independent samples t-tests. Differences between baseline and 1 week and 1 month after exercise will be analysed using a repeated measures F-test. All statistical analyses were conducted with a statistical threshold P-value of <0.05. The data collected through fNIRS will be performed via NirSpark analysis software. The general linear model (GLM) will be applied to integrate task effects and assess activation in relevant brain regions. To analyze the rsFC of brain in children with ASD before and after the exercise intervention, the FC_NIRS toolbox is used.
- Ethical matters and data protection. The patients participated in the study will sign the informed consent (obtained from the guardian). And this study was approved by the local ethics committee. Patient's name will be abbreviated and the research data will be assigned a code then to provide to the researcher. The authorization from parents on the patient's health information remains valid until the study is completed. After that, researchers will delete private information from the study record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The children are randomly divided into a intervention group and a control group. On the basis of the basic ASD rehabilitation training, the children will be trained for 12 weeks (5 days/week, 60 minutes/day). The intervention group received systematic exercise training (the Child-Parent- Trainer exercise program), while the control group received regular physical training courses.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: The Child-Parent- Trainer exercise programThe intervention group received systematic exercise training (the Child-Parent- Trainer exercise program) for 12 weeks (5 days/week, 60 minutes/day). |
| Control group | Active comparator | Procedure: The regular physical trainingThe control group received regular physical training courses for 12 weeks (5 days/week, 60 minutes/day). |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
- Able to simply ask and answer questions.
Key exclusion criteria (6 listed)
- 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.
- Participants who changed treatment intervention midway after inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Child-Parent- Trainer exercise programThe 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. | Procedure or surgery | Intervention group |
| The regular physical trainingThe 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. | Procedure or surgery | Control group |
Primary outcome
The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2
Time frame: Training weeks 0, 13, and 17.
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.
The changes in degree of ASD disorder by Childhood Autism Rating Scale (CARS)
Time frame: Training weeks 0, 13, and 17.
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.
The changes of executive functions
Time frame: Training weeks 0, 13, and 17.
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.
The changes of brain function detection indicators
Time frame: Training weeks 0, 13, and 17.
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.
4 secondary outcomes
The changes of children's life quality by Child Eating Behavior Questionnaire (CEBQ)
Time frame: Training weeks 0, 13, and 17.
The changes of children's life quality by Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Training weeks 0, 13, and 17.
The changes of parents' life quality by Parenting Stress Index (PSI)
Time frame: Training weeks 0, 13, and 17.
The changes in heart rate
Time frame: At exercise training.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Results publication: PubMed 30078460Lord C, Elsabbagh M, Baird G, Veenstra-Vanderweele J. Autism spectrum disorder. Lancet. 2018 Aug 11;392(10146):508-520. doi: 10.1016/S0140-6736(18)31129-2. Epub 2018 Aug 2.
- Results publication: PubMed 30508021Xu G, Strathearn L, Liu B, O'Brien M, Kopelman TG, Zhu J, Snetselaar LG, Bao W. Prevalence and Treatment Patterns of Autism Spectrum Disorder in the United States, 2016. JAMA Pediatr. 2019 Feb 1;173(2):153-159. doi: 10.1001/jamapediatrics.2018.4208.
- Results publication: PubMed 28439105Demetriou EA, Lampit A, Quintana DS, Naismith SL, Song YJC, Pye JE, Hickie I, Guastella AJ. Autism spectrum disorders: a meta-analysis of executive function. Mol Psychiatry. 2018 May;23(5):1198-1204. doi: 10.1038/mp.2017.75. Epub 2017 Apr 25.
- Results publication: PubMed 31921482Lippi G, Mattiuzzi C, Sanchis-Gomar F. Updated overview on interplay between physical exercise, neurotrophins, and cognitive function in humans. J Sport Health Sci. 2020 Jan;9(1):74-81. doi: 10.1016/j.jshs.2019.07.012. Epub 2019 Sep 6.
- Results publication: PubMed 34387753Zampella CJ, Wang LAL, Haley M, Hutchinson AG, de Marchena A. Motor Skill Differences in Autism Spectrum Disorder: a Clinically Focused Review. Curr Psychiatry Rep. 2021 Aug 13;23(10):64. doi: 10.1007/s11920-021-01280-6.
- Results publication: PubMed 33307759Chan JS, Deng K, Yan JH. The effectiveness of physical activity interventions on communication and social functioning in autistic children and adolescents: A meta-analysis of controlled trials. Autism. 2021 May;25(4):874-886. doi: 10.1177/1362361320977645. Epub 2020 Dec 11.
- Results publication: PubMed 33165523Sandbank M, Bottema-Beutel K, Woynaroski T. Intervention Recommendations for Children With Autism in Light of a Changing Evidence Base. JAMA Pediatr. 2021 Apr 1;175(4):341-342. doi: 10.1001/jamapediatrics.2020.4730. No abstract available.
- Results publication: PubMed 39435130Jia M, Zhang J, Pan J, Hu F, Zhu Z. Benefits of exercise for children and adolescents with autism spectrum disorder: a systematic review and meta-analysis. Front Psychiatry. 2024 Oct 7;15:1462601. doi: 10.3389/fpsyt.2024.1462601. eCollection 2024.
- Results publication: PubMed 39806448Tao R, Yang Y, Wilson M, Chang JR, Liu C, Sit CHP. Comparative effectiveness of physical activity interventions on cognitive functions in children and adolescents with Neurodevelopmental Disorders: a systematic review and network meta-analysis of randomized controlled trials. Int J Behav Nutr Phys Act. 2025 Jan 13;22(1):6. doi: 10.1186/s12966-024-01702-7.
- Results publication: PubMed 23874533Chan AS, Sze SL, Siu NY, Lau EM, Cheung MC. A chinese mind-body exercise improves self-control of children with autism: a randomized controlled trial. PLoS One. 2013 Jul 10;8(7):e68184. doi: 10.1371/journal.pone.0068184. Print 2013.
- Results publication: PubMed 36620673Toscano CVA, Ferreira JP, Quinaud RT, Silva KMN, Carvalho HM, Gaspar JM. Exercise improves the social and behavioral skills of children and adolescent with autism spectrum disorders. Front Psychiatry. 2022 Dec 22;13:1027799. doi: 10.3389/fpsyt.2022.1027799. eCollection 2022.
- Results publication: PubMed 39361117Grospretre S, Ruffino C, Derguy C, Gueugneau N. Sport and Autism: What Do We Know so Far? A Review. Sports Med Open. 2024 Oct 3;10(1):107. doi: 10.1186/s40798-024-00765-x.
- Individual participant dataSharing planned: No. Data is confidential during the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Chen, doctor study director
Children's Hospital of Chongqing Medical University
yu T Li, Doctor study chair
Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Child-Parent- Trainer exercise program and The regular physical training in people with Autism Spectrum Disorder, run by Chen Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Chen, doctor (136 7762 0103 ext. +86, chenli2012@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in degree of ASD disorder by Autism Diagnostic Observation Schedule-2 (time frame: Training weeks 0, 13, and 17.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07104708, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.