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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Therapy
• Intervention / Treatment: Behavioral: Strategies for Toddler ASD with Remote-therapy (STAR); Behavioral: Community intervention

Detailed Description

Autism spectrum disorder (ASD) brings enormous economic and emotional burdens to families and society with its ever-increasing prevalence. Early intervention has been proved as the key treatment to ASD. Along with increasing number of ASD children identified and diagnosed at early stage, the needs for effective early intervention are dramatically increasing. Though therapist-delivered intensive programs for toddlers yield substantive developmental gains, they tend to be costly and with extremely limited resource. The lockdowns during the COVID-19 pandemic brings even more obstacles for the children and families to get access to the resource of intervention. As such, the traditional intervention models are not fit for wide implementation within the Chinese public health systems and pandemic situation.

To solve this dilemma, this project aims to develop and implement the Strategies for Toddler ASD with Remote-therapy (STAR) model for early toddlers with ASD in local community sites in Shanghai. To maximize the intervention effect, 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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiong Xu, PhD; Phone Number: 02164931275; Email: xuqiong@fuda.edu.cn
• Study Contact Backup: Name: Chunchun Hu, MD; Phone Number: 15721445658; Email: 14211240007@fudan.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201102
      • Recruiting
      • Children's Hospital of Fudan University
      • Contact: Qiong Xu, PhD; Email: stellaxuqiong@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAR intervention group; 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.	Behavioral: Strategies for Toddler ASD with Remote-therapy (STAR); 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
Other: community intervention group; This group will have community interventions parents can choose.	Behavioral: Community intervention; Regular community intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Communication and Symbolic Behavior Scales Developmental Profile（CSBS）	The Checklist consists of 24 questions that range from 2 to 4 points within each of 7 Clusters, including language predictors: emotion and eye gaze, communication, gestures, sounds, words, understanding, and object use. Give credit of 0 points for items checked Not Yet, 1 point for items checked Sometimes, or 2 points for items checked Often. 7 Cluster scores will be summed to yield three Composite scores (including expressive speech, symbolic and communication) and a total score. The change of each score for T0, T1 and T2 will be measured.	from enrollment (T0) to 1 year(T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autism Diagnostic Observation Schedule-Second edition(ADOS-2)	Autism Diagnostic Observation Schedule-Second edition(ADOS-2): The results from the social affect(SA) and restricted and repetitive behavior (RRB, subdomains were added together to generate the total raw score. The total raw score was converted into the ADOS calibrated severity score , ranging from 1 to 10, with 10 being the most severe.	from enrollment (T0) to 1 year(T2)
Parenting Stress Index/Short Form （PSI/SF）	3 sub-scales, including parent distress (PD), parent-child dysfunctional interaction(PCDI), difficult child (DC). This scale assesses stress in parents.	from enrollment (T0) 1 year(T2)
The Griffiths Mental Development Scales (GMDS)	GMDS includes six subscales: Locomotor (Lm), Personal and Social (P/S), Hearing and Speech (H/Sp), Eye and Hand (E/Hd), Performance (Pf) and Practical Reasoning (Pr). The raw scores were transformed into developmental quotients (DQ) using the standard method.	from enrollment (T0) 1 year(T2)

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Autism; Intervention; Naturalistic developmental behavioral intervetion
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: STAR-ASD 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No