Remote therapy strategies for toddlers with autism
Strategies for Toddler ASD With Remote-therapy (STAR) Model for Early ASD Toddlers: a Randomized Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 16 Months to 30 Months |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05901558 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are toddlers who have been screened positive for Autism Spectrum Disorder.
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.
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 performed: While traditional intervention models have shown success, the STAR model's remote therapy approach is relatively novel and untested in this specific context.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.