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Search / Trial NCT05901558

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

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Jun 12, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Autism Naturalistic Developmental Behavioral Intervetion Intervention

ClinConnect Summary

The STAR trial is a research study focusing on young children diagnosed with Autism Spectrum Disorder (ASD). The goal is to test a new way of providing therapy, called the Strategies for Toddler Autism Spectrum Disorder with Remote-Therapy (STAR) model. This study will take place over three years in community centers in Shanghai. Children who join the study will be placed in one of two groups: one will receive the STAR therapy, while the other will participate in community-based interventions.

To be eligible for this study, children need to be between 18 months and 3 years old and have been identified as potentially having ASD through a two-step screening process. This means they will first complete a simple checklist and then a more detailed assessment. Children with other serious health issues, such as severe hearing loss or genetic conditions that could affect their development, are not able to participate. Families who join the trial can expect regular therapy sessions and follow-ups to monitor progress, helping researchers understand how effective the STAR approach is in supporting toddlers with ASD.

Gender

ALL

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.

About Children's Hospital Of Fudan University

The Children's Hospital of Fudan University is a leading pediatric healthcare institution in China, renowned for its commitment to advancing child health through innovative research and clinical excellence. As a prominent clinical trial sponsor, the hospital focuses on conducting high-quality, ethically-driven studies that aim to improve pediatric care and treatment outcomes. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital leverages its robust infrastructure and expertise to facilitate groundbreaking clinical trials, ensuring the safety and well-being of child participants while contributing valuable insights to the global medical community.

Locations

Shanghai, Shanghai, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported