Clinical trial NCT05901558: Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Official title: Strategies for Toddler ASD With Remote-therapy (STAR) Model for Early ASD Toddlers: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Therapy
Keywords: Autism
Naturalistic developmental behavioral intervetion
Intervention
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Change of Communication and Symbolic Behavior Scales Developmental Profile（CSBS）
timeFrame: from enrollment (T0) to 1 year(T2)
Secondary outcomes:
measure: Autism Diagnostic Observation Schedule-Second edition(ADOS-2)
timeFrame: from enrollment (T0) to 1 year(T2)
measure: Parenting Stress Index/Short Form （PSI/SF）
timeFrame: from enrollment (T0) 1 year(T2)
measure: The Griffiths Mental Development Scales (GMDS)
timeFrame: from enrollment (T0) 1 year(T2)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References: