Remote therapy strategies for toddlers with autism
Official title: Strategies for Toddler ASD With Remote-therapy (STAR) Model for Early ASD Toddlers: a Randomized Trial
Run by Children's Hospital of Fudan University · NCT05901558 · Data updated 2026-11-12
This study is testing a new remote therapy program for toddlers with autism to see if it helps improve their social and communication skills better than regular community support.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Months to 30 Months |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | June 15, 2023 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT05901558 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are toddlers who have been screened positive for Autism Spectrum Disorder.
✕Probably not a fit
Patients with other neurological or degenerative diseases, severe sensory impairments, or genetic anomalies that may affect intervention outcomes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to develop and implement the Strategies for Toddler Autism Spectrum Disorder (ASD) with Remote-therapy (STAR) model for early toddlers diagnosed with ASD in community sites in Shanghai. It is a randomized control trial lasting three years, where children will be divided into two groups: one receiving the STAR intervention and the other receiving community intervention. The STAR model incorporates Naturalistic Developmental Behavioral Intervention (NDBI) strategies to enhance social and communication skills in natural settings, addressing the challenges posed by traditional intervention methods, especially during the COVID-19 pandemic.
Why it matters
Potential benefit: If successful, this approach could provide effective early intervention for toddlers with ASD, improving their developmental outcomes.
How similar studies have gone: While traditional intervention models have shown success, the STAR model's remote therapy approach is relatively novel and untested in this specific context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children screened as positive for ASD. * Two-tiered screening process combing Level 1(The Modified Checklist for Autism in Toddlers-Revised/Follow-Up , M-CHAT-R/F) and Level 2 (The Screening Tool for Autism in Toddlers and Young Children, STAT) Exclusion Criteria: * Other neurologic or degenerative diseases; * Severe hearing or visual impairment; * Genetic anomaly which may affect impact on intervention; * Not available for regular intervention and follow-up.
Where it's running
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Qiong Xu, PhD
- Email: xuqiong@fuda.edu.cn
- Phone: 02164931275
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.