Autism Spectrum DisorderNCT07532395
FMS-CrossFit Training Program (FCTP) to Improve School Readiness in Preschool Children With Autism Spectrum Disorder
A study testing FCTP program in people with Autism Spectrum Disorder, run by Peking University at 2 sites in China.
Trial summary
Autism spectrum disorder (ASD) is an increasing public health concern, with preschool children often exhibiting persistent deficits in school readiness. However, targeted and developmentally comprehensive interventions remain limited. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- FCTP program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesChina
- Study dates
- 22 Nov 2025to 24 Apr 2027
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 3-6 years;
- confirmed ASD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria or the Autism Diagnostic Observation Schedule-Second Edition (ADOS-2);
- written informed consent from parent/caregiver.
Who cannot join
- participation in structured exercise programs within the preceding 6 months;
- comorbid severe neurological disorders (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis) or major psychiatric conditions (e.g., schizophrenia, bipolar disorder);
- visual, auditory or intellectual impairments that would interfere with participation;
- history of significant head trauma or brain injury;
- medical contraindications to physical activity ;
- other factors deemed unsuitable for program participation by the research team.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Pku Care Brain Health
Beijing, Beijing Municipality, 100088
Yawen Zhou, +86 13269477857, bd-jiangchundi936@pkucare.com
- Recruiting
Fujian Provincial Maternity and Children's Hospital
Fuzhou, Fujian, 350001
Yanzheng Pan, PhD candidate, (+86)13161439008, panyanzheng@stu.pku.edu.cn
Xinxin Huang, master
About this study
Official title: A Randomized Controlled Trial of the FMS-CrossFit Training Program (FCTP) to Improve School Readiness in Preschool Children With Autism Spectrum Disorder
Autism spectrum disorder (ASD) is an increasing public health concern, with preschool children often exhibiting persistent deficits in school readiness. However, targeted and developmentally comprehensive interventions remain limited. This randomized controlled trial will evaluate a 12-week Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 children with ASD aged 3-6 years, compared with a Treatment As Usual (TAU) control group. The program integrates progressive FMS training with CrossFit-style circuit training to improve motor competence, social interaction, and self-regulation. Primary outcomes focus on school readiness assessed by the Strengths and Difficulties Questionnaire (SDQ), while secondary outcomes include motor development, executive function, social responsiveness, and biomarkers. Assessments will be conducted at baseline, mid-intervention (8 weeks), post-intervention (12 weeks), and follow-up (20 weeks).
Read the detailed description
Autism spectrum disorder (ASD) is a major public health concern, and increasing prevalence underscores the need for evidence-based interventions that improve functional outcomes. While school readiness is a critical developmental milestone, deficits remain pervasive among preschoolers with ASD, yet targeted interventions remain scarce. Exercise interventions grounded in Fundamental Movement Skills (FMS) are promising, but many existing approaches lack systematic progression and do not adequately address the multidimensional nature of school readiness.
This randomized controlled trial will evaluate the effectiveness of a novel Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 preschool children with ASD aged 3-6 years. Participants will be randomly assigned to the FCTP intervention group or a Treatment As Usual (TAU) control group using a computer-generated randomization. The FCTP is a 12-week structured program integrating FMS development through CrossFit-style circuit training, designed to enhance motor competence, social interaction, and self-regulation skills essential for school readiness. Primary outcomes will include school readiness measures assessed using the Strengths and Difficulties Questionnaire (SDQ). Secondary outcomes will encompass motor development, executive function, social responsiveness, and biomarker analyses. Assessments will be conducted at baseline, 8 weeks (mid-intervention), 12 weeks (end-of-intervention), and 20 weeks (8 weeks post-intervention).
Discussion: This study will address a critical gap in early intervention research by targeting school readiness through a systematic, theory-driven approach combining motor skill development with social learning opportunities. The FCTP will offer several advantages over traditional interventions: systematic FMS progression, group-based social interaction, cost-effectiveness, and high implementation feasibility. By integrating neuroplasticity principles with contextual learning, this intervention will provide a comprehensive approach to preparing children with ASD for successful educational transitions.
- Conditions
- Autism Spectrum Disorder
- Being tested
- FCTP program, treatment as usual (TAU) (Control Group)
- Keywords
- Autism Spectrum Disorder, CrossFit
- 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.
FCTP programBehavioural
Also called Fundamental Movement Skills-CrossFit Training Program
Each session consists of three parts: warm up (5 minutes), basic motor skills training (25 minutes) and cool-down with stretching (5 minutes). The program combines physical, social, linguistic and communication skills training aspects, and can be divided into three phases (about 2 to 4 weeks for each phase) to achieve different targets.
Stage 1: Basic Motor Skills Learning Stages:
This stage primarily focuses on low-intensity activities over a period of 1 to 3 weeks.
Stage 2: Basic Motor Skills Proficiency Stage:
This stage is characterized by low to moderate intensity and typically lasts for 4 to 7 weeks.
Stage 3: Basic Motor Skills Enhancement stage:
This stage is conducted at a moderate intensity and focuses on the intensive development of motor skills over a period from 8 to 12 weeks.
treatment as usual (TAU) (Control Group)Behavioural
Also called Treatment As Usual
The control group receives treatment as usual (TAU), allowing participants to engage in routine services of their choice, including sensory integration therapy, social skills training, language intervention, Transcranial Magnetic Stimulation (TMS), etc.
| Study group | Role | What they receive |
|---|---|---|
| FCTP intervention group | Experimental | Participants in the FCTP intervention group will receive two supervised sessions per week of the novel Fundamental Movement Skills-CrossFit Training Program (FCTP), in place of traditional sensory integration therapy. Receives: Behavioral: FCTP program |
| control group | Active comparator | The control group receives treatment as usual (TAU), allowing participants to engage in routine services of their choice, including sensory integration therapy, social skills training, language intervention, transcranial magnetic stimulation (TMS), etc. Receives: Behavioral: treatment as usual (TAU) (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
School readiness
The Strengths and Difficulties Questionnaire (SDQ) was used to assess school readiness. The Total Difficulties Score ranges from 0 to 40, with higher scores indicating more severe difficulties in the child.
Measured: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)
Gross Motor Development
The Test of Gross Motor Development - 3rd edition (TGMD-3) is a measure of fundamental motor skills.
Measured: baseline, post-intervention (12 weeks)
Secondary outcomes (8)
Severity of autism
The Autism Behavior Checklist (ABC) is a widely used screening instrument comprising 57 items that characterize behavioral features of children with autism. The scores range from 0 to 228, with higher scores indicating greater symptom severity in the child.
Measured: baseline, post-intervetion (12 weeks)
Social responsiveness
The social responsiveness scale-2 (SRS-2) is a 65-item parent-reported questionnaire designed to measure the severity of autism symptoms as a quantitative trait. The scores range from 0 to 195, with higher scores indicating more severe problems in the child.
Measured: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Executive function
The Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item in five subscales screening for executive function impairment in ages 5-18 years. The Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) is a validated tool for assessing executive function in children aged 2-5 based on daily behaviors. The scores range from 0 to 189, with higher scores indicating greater symptom severity in the child.
Measured: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)
Neuropsychological assessment
The Early Years Toolbox (EYT) is a low-cost iPad software to assess young children's expressive language, executive function, and social development.
Measured: baseline, post-intervention (12 weeks)
Caregiver burden
Zarit Caregiver Burden Interview is a widely used tool for measuring caregiver burden. The scores range from 0 to 16, with higher scores indicating greater burden.
Measured: baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)
Sleeping conditions
The Children's Sleep Habits Questionnaire (CSHQ) comprises eight subscales that assess different aspects of sleep behaviors. The scores range from 0 to 99, with higher scores indicating greater symptom severity in the child.
Measured: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Appetite status
The initiative eating subscale of the Chinese Preschoolers' Eating Behavior Questionnaire (CPEBQ-IE) has 7 questions that assess the active eating behaviors of preschool children. The scores range from 0 to 20, with lower scores indicating greater symptom severity in the child.
Measured: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Gastrointestinal issues
The 6-item Gastrointestinal Severity Index (6-GSI) is employed for evaluating gastrointestinal symptoms. The scores range from 0 to 12, with higher scores indicating greater symptom severity in the child.
Measured: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start22 Nov 2025
- Primary completion24 Nov 2026 (estimated)
- Study completion24 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuelong Ji, PHD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532395
- Sponsor's protocol ID
- IRB00001052-25110-A01
- Status last verified
- Feb 2026
- First submitted
- 8 Apr 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to participant privacy and confidentiality protections. The informed consent did not include provisions for data sharing beyond the research team, and relevant data protection regulations preclude dissemination of identifiable personal health information.
Publications
Zhang L, Zhang C, Yuan X, Ji Y. The impact of exercise interventions on core symptoms of 3-12-year-old children with autism spectrum disorder: a systematic review and network meta-analysis. Eur Child Adolesc Psychiatry. 2025 Jul;34(7):1991-2005. doi: 10.1007/s00787-025-02696-8. Epub 2025 Mar 25.
PubMed 40131458
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the FMS-CrossFit Training Program (FCTP) to Improve School Readiness in Preschool Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07532395
- Acronym / sponsor ID
- IRB00001052-25110-A01
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, CrossFit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 24 Apr 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
Autism spectrum disorder (ASD) is an increasing public health concern, with preschool children often exhibiting persistent deficits in school readiness. However, targeted and developmentally comprehensive interventions remain limited. This randomized controlled trial will evaluate a 12-week Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 children with ASD aged 3-6 years, compared with a Treatment As Usual (TAU) control group. The program integrates progressive FMS training with CrossFit-style circuit training to improve motor competence, social interaction, and self-regulation. Primary outcomes focus on school readiness assessed by the Strengths and Difficulties Questionnaire (SDQ), while secondary outcomes include motor development, executive function, social responsiveness, and biomarkers. Assessments will be conducted at baseline, mid-intervention (8 weeks), post-intervention (12 weeks), and follow-up (20 weeks).
Detailed description
Autism spectrum disorder (ASD) is a major public health concern, and increasing prevalence underscores the need for evidence-based interventions that improve functional outcomes. While school readiness is a critical developmental milestone, deficits remain pervasive among preschoolers with ASD, yet targeted interventions remain scarce. Exercise interventions grounded in Fundamental Movement Skills (FMS) are promising, but many existing approaches lack systematic progression and do not adequately address the multidimensional nature of school readiness.
This randomized controlled trial will evaluate the effectiveness of a novel Fundamental Movement Skills-CrossFit Training Program (FCTP) in 184 preschool children with ASD aged 3-6 years. Participants will be randomly assigned to the FCTP intervention group or a Treatment As Usual (TAU) control group using a computer-generated randomization. The FCTP is a 12-week structured program integrating FMS development through CrossFit-style circuit training, designed to enhance motor competence, social interaction, and self-regulation skills essential for school readiness. Primary outcomes will include school readiness measures assessed using the Strengths and Difficulties Questionnaire (SDQ). Secondary outcomes will encompass motor development, executive function, social responsiveness, and biomarker analyses. Assessments will be conducted at baseline, 8 weeks (mid-intervention), 12 weeks (end-of-intervention), and 20 weeks (8 weeks post-intervention).
Discussion: This study will address a critical gap in early intervention research by targeting school readiness through a systematic, theory-driven approach combining motor skill development with social learning opportunities. The FCTP will offer several advantages over traditional interventions: systematic FMS progression, group-based social interaction, cost-effectiveness, and high implementation feasibility. By integrating neuroplasticity principles with contextual learning, this intervention will provide a comprehensive approach to preparing children with ASD for successful educational transitions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FCTP intervention group | Experimental | Behavioral: FCTP programParticipants in the FCTP intervention group will receive two supervised sessions per week of the novel Fundamental Movement Skills-CrossFit Training Program (FCTP), in place of traditional sensory integration therapy. |
| control group | Active comparator | Behavioral: treatment as usual (TAU) (Control Group)The control group receives treatment as usual (TAU), allowing participants to engage in routine services of their choice, including sensory integration therapy, social skills training, language intervention, transcranial magnetic stimulation (TMS), etc. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age 3-6 years;
- confirmed ASD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria or the Autism Diagnostic Observation Schedule-Second Edition (ADOS-2);
- written informed consent from parent/caregiver.
Key exclusion criteria (6 listed)
- participation in structured exercise programs within the preceding 6 months;
- comorbid severe neurological disorders (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis) or major psychiatric conditions (e.g., schizophrenia, bipolar disorder);
- visual, auditory or intellectual impairments that would interfere with participation;
- history of significant head trauma or brain injury;
- medical contraindications to physical activity ;
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 |
|---|---|---|
| FCTP programAlso: Fundamental Movement Skills-CrossFit Training ProgramEach session consists of three parts: warm up (5 minutes), basic motor skills training (25 minutes) and cool-down with stretching (5 minutes). The program combines physical, social, linguistic and communication skills training aspects, and can be divided into three phases (about 2 to 4 weeks for each phase) to achieve different targets. Stage 1: Basic Motor Skills Learning Stages: This stage primarily focuses on low-intensity activities over a period of 1 to 3 weeks. Stage 2: Basic Motor Skills Proficiency Stage: This stage is characterized by low to moderate intensity and typically lasts for 4 to 7 weeks. Stage 3: Basic Motor Skills Enhancement stage: This stage is conducted at a moderate intensity and focuses on the intensive development of motor skills over a period from 8 to 12 weeks. | Behavioural | FCTP intervention group |
| treatment as usual (TAU) (Control Group)Also: Treatment As UsualThe control group receives treatment as usual (TAU), allowing participants to engage in routine services of their choice, including sensory integration therapy, social skills training, language intervention, Transcranial Magnetic Stimulation (TMS), etc. | Behavioural | control group |
Primary outcome
School readiness
Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)
The Strengths and Difficulties Questionnaire (SDQ) was used to assess school readiness. The Total Difficulties Score ranges from 0 to 40, with higher scores indicating more severe difficulties in the child.
Gross Motor Development
Time frame: baseline, post-intervention (12 weeks)
The Test of Gross Motor Development - 3rd edition (TGMD-3) is a measure of fundamental motor skills.
8 secondary outcomes
Severity of autism
Time frame: baseline, post-intervetion (12 weeks)
Social responsiveness
Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Executive function
Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks)
Neuropsychological assessment
Time frame: baseline, post-intervention (12 weeks)
Caregiver burden
Time frame: baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks)
Sleeping conditions
Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Appetite status
Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
Gastrointestinal issues
Time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks)
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 20 Oct 2026.
- Results publication: PubMed 40131458Zhang L, Zhang C, Yuan X, Ji Y. The impact of exercise interventions on core symptoms of 3-12-year-old children with autism spectrum disorder: a systematic review and network meta-analysis. Eur Child Adolesc Psychiatry. 2025 Jul;34(7):1991-2005. doi: 10.1007/s00787-025-02696-8. Epub 2025 Mar 25.
- Individual participant dataSharing planned: No. IPD will not be shared due to participant privacy and confidentiality protections. The informed consent did not include provisions for data sharing beyond the research team, and relevant data protection regulations preclude dissemination of identifiable personal health information.
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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.
Yuelong Ji, PHD principal investigator
Peking University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FCTP program in people with Autism Spectrum Disorder, run by Peking University at 2 sites 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 3 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yuelong Ji, PHD ((+86)13161989008, yuelong.ji@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School readiness (time frame: baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks)). The study lists 2 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 NCT07532395, which also lists 1 linked publication.
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 20 Oct 2026.