Remote Therapy Model for Toddlers With Autism Spectrum Disorder
Tests a remote-delivered STAR therapy program against community care in toddlers with autism.
Key facts
- Who runs it
- Children's Hospital of Fudan University
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
- Status
- Recruiting
- People taking part
- 110 people, planned
- Started
- 15 Jun 2023
- Expected to end
- 30 Dec 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Strategies for Toddler ASD with Remote-therapy (STAR)
- Community intervention
- Record updated
- 26 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for toddlers aged 16 to 30 months who screened positive for autism spectrum disorder (ASD). It tests a remote-therapy program against community care.
- Age
- 16 Months to 30 Months
- Sex
- All sexes can join.
- Disease stage
- Children who screened positive for ASD on a two-step screening: M-CHAT-R/F, then STAT.
Main reasons for not taking part
- Other neurologic or degenerative diseases
- Severe hearing or visual impairment
- A genetic anomaly that may affect the effect of the intervention
- Not available for regular intervention and follow-up
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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 in China
- Children's Hospital Of Fudan UniversityShanghai, ChinaContact: Qiong Xu, PhDTaking people
About the trial
What the trial wants to find out
The project aims to develop and implement the Strategies for Toddler Autism spectrum disorder(ASD) with Remote-therapy (STAR) model for early toddlers with ASD in local community sites in Shanghai. It's a randomized control trial lasting 3 years. The children will be divided into 2 groups, one for STAR intervention group and the other for community intervention group. The STAR intervention group will be performed STAR other than community intervention.
The 2 groups in the trial
- STAR intervention groupTreatment being tested
The intervention strategies in STAR model are designed under the Naturalistic Developmental Behavioral Intervention (NDBI) framework which are implemented in natural settings targeting at improving social and communicational capabilities. The structure of the STAR model is with 2 modules and 16 sessions. Module I derives from our previous offline parent-tutoring courses with 8 intervention strategy topics combining academic instruction and real child demonstration but modified into on-line version. Module II is designed specifically for long-term consolidation of parents' intervention skills containing 8 biweekly sessions of distance coaching with parents practicing intervention with their children in real time at home.
Treatment: Strategies for Toddler ASD with Remote-therapy (STAR)
- community intervention groupOther group
This group will have community interventions parents can choose.
Treatment: Community intervention
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Strategies for Toddler ASD With Remote-therapy (STAR) Model for Early ASD Toddlers: a Randomized Trial
- Plain-language title
- Remote Therapy Model for Toddlers With Autism Spectrum DisorderGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 26 October 2026