Autism Spectrum Disorder
Conditions
Keywords
Autism Spectrum Disorder, CrossFit
Brief 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. 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.
Interventions
BEHAVIORALFCTP 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.
BEHAVIORALtreatment 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.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. age 3-6 years; 2. 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); 3. written informed consent from parent/caregiver.
Exclusion criteria
1. participation in structured exercise programs within the preceding 6 months; 2. comorbid severe neurological disorders (e.g., epilepsy, phenylketonuria, fragile X syndrome, tuberous sclerosis) or major psychiatric conditions (e.g., schizophrenia, bipolar disorder); 3. visual, auditory or intellectual impairments that would interfere with participation; 4. history of significant head trauma or brain injury; 5. medical contraindications to physical activity ; 6. other factors deemed unsuitable for program participation by the research team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| School readiness | 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 | baseline, post-intervention (12 weeks) | The Test of Gross Motor Development - 3rd edition (TGMD-3) is a measure of fundamental motor skills. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of autism | baseline, post-intervetion (12 weeks) | 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. |
| Social responsiveness | baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks) | 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. |
| Executive function | baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeeks) | 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. |
| Neuropsychological assessment | baseline, post-intervention (12 weeks) | The Early Years Toolbox (EYT) is a low-cost iPad software to assess young children's expressive language, executive function, and social development. |
| Caregiver burden | baseline, 8 weeks post-baseline, post intervention(12 weeks), follow up(20 weeks) | 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. |
| Sleeping conditions | baseline, 8 weeks post-baseline, post-intervention (12 weeks) | 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. |
| Appetite status | baseline, 8 weeks post-baseline, post-intervention (12 weeks) | 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. |
| Gastrointestinal issues | baseline, 8 weeks post-baseline, post-intervention (12 weeks), follow-up (20 weeks) | 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. |
Countries
China
Contacts
CONTACTYuelong Ji, PHD
PRINCIPAL_INVESTIGATORYuelong Ji, PHD
Peking University
Outcome results
None listed