Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-30
SponsorChildren's Hospital of Fudan University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Strategies for Toddler ASD with Remote-therapy (STAR)
BehavioralThe 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
Community intervention
BehavioralRegular community intervention
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: STAR intervention groupExperimental treatment 1 intervention
Group B: community intervention groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
from enrollment (T0) to 1 year(T2)Secondary outcomes
1
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.
Time frame
from enrollment (T0) to 1 year(T2)2
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.
Time frame
from enrollment (T0) 1 year(T2)3
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.
Time frame
from enrollment (T0) 1 year(T2)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov