Actively Recruiting

Phase Not Applicable
Age: 16Months - 30Months
All Genders
ID05901558

Strategies for Toddler ASD With Remote-therapy (STAR) Model for Early ASD Toddlers: a Randomized Trial

Led by Children's Hospital of Fudan University · Updated on 2025-09-05

110

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to develop and implement the Strategies for Toddler Autism Spectrum Disorder (ASD) with Remote-therapy (STAR) model for early toddlers with ASD in community sites in Shanghai. The project addresses the growing need for early, effective intervention for toddlers with ASD, especially considering the challenges posed by the COVID-19 pandemic and limited traditional intervention resources. The study is a randomized controlled trial lasting three years, comparing the STAR model to regular community interventions. The STAR model uses strategies based on the Naturalistic Developmental Behavioral Intervention (NDBI) framework, focusing on improving social and communication skills in natural settings. The intervention consists of two modules: Module I includes 8 online sessions with academic instruction and real child demonstrations adapted from previous offline parent-tutoring courses. Module II contains 8 biweekly coaching sessions where parents practice techniques with their children in real time at home. Participants are divided into two groups: one receiving the STAR intervention and the other receiving community interventions chosen by parents. Participants are young children aged between 16 and 30 months who have screened positive for ASD using a two-step screening process. Researchers will assess developmental progress using tools such as the Communication and Symbolic Behavior Scales Developmental Profile (CSBS), Autism Diagnostic Observation Schedule-Second edition (ADOS-2), Parenting Stress Index/Short Form (PSI/SF), and Griffiths Mental Development Scales (GMDS) over one year. The study includes regular follow-up and monitoring to evaluate the impact of the interventions on child development and parental stress over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 16Months - 30Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children screened as positive for ASD
  • Passed two-tiered screening process combining Level 1 (M-CHAT-R/F) and Level 2 (STAT)
  • Age between 16 and 30 months
Not Eligible

You will not qualify if you...

  • Other neurologic or degenerative diseases
  • Severe hearing or visual impairment
  • Genetic anomaly affecting intervention impact
  • Not available for regular intervention and follow-up visits or sessions in the study period

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants undergo a two-tiered screening process combining Level 1 (M-CHAT-R/F) and Level 2 (STAT)

Outpatient Treatment

Duration - Approximately 6 months

Participants receive the STAR intervention or community intervention in natural settings targeting social and communicational improvements. The STAR model includes 2 modules with 16 sessions: 8 online parent-tutoring sessions and 8 biweekly distance coaching sessions.

16 intervention sessions including 8 online tutoring sessions and 8 biweekly coaching sessions

Follow-up

Duration - Up to 1 year

Participants are assessed for developmental progress and intervention impact over one year from enrollment.

Follow-up assessments at enrollment, 6 months, and 1 year

Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

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Research Team

Q

Qiong Xu, PhD

C

Chunchun Hu, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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