Clinical trial Recruiting at 1 site Interventional Ages 16 Months to 30 Months

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 typeInterventional
Ages16 Months to 30 Months
SexAll
Enrollment110 (estimated)
SponsorChildren's Hospital of Fudan University
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedJune 15, 2023
Main results expectedDecember 30, 2026
Study endsDecember 30, 2026
Registry record updatedOctober 26, 2026
Trial IDNCT05901558 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

  • Children's Hospital of Fudan University
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.