Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Strategies for Toddler ASD with Remote-therapy (STAR), Community intervention.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder, Therapy. Basic parameters: 16 months — 30 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Strategies for Toddler ASD With Remote-therapy (STAR) Model for Early ASD Toddlers: a Randomized Trial
Overview
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.
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.
Interventions
- 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 - Behavioral Community intervention
Regular community intervention
Primary outcome measures
- Change of Communication and Symbolic Behavior Scales Developmental Profile（CSBS） [Time frame: from enrollment (T0) to 1 year(T2)]
Secondary outcome measures (3)
- Autism Diagnostic Observation Schedule-Second edition(ADOS-2) [Time frame: from enrollment (T0) to 1 year(T2)]
- Parenting Stress Index/Short Form （PSI/SF） [Time frame: from enrollment (T0) 1 year(T2)]
- The Griffiths Mental Development Scales (GMDS) [Time frame: from enrollment (T0) 1 year(T2)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT05901558 · STAR-ASD 1.0