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Recruiting NCT05901558

NCT05901558 Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD

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Clinical Trial Summary
NCT ID NCT05901558
Status Recruiting
Phase
Sponsor Children's Hospital of Fudan University
Condition Autism Spectrum Disorder
Study Type INTERVENTIONAL
Enrollment 110 participants
Start Date 2023-06-15
Primary Completion 2026-12-30

Trial Parameters

Condition Autism Spectrum Disorder
Sponsor Children's Hospital of Fudan University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 110
Sex ALL
Min Age 16 Months
Max Age 30 Months
Start Date 2023-06-15
Completion 2026-12-30
Interventions
Strategies for Toddler ASD with Remote-therapy (STAR)Community intervention

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Brief Summary

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.

Eligibility 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.

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