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

Primary Purpose

Autism Spectrum Disorder, Therapy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Strategies for Toddler ASD with Remote-therapy (STAR)
Community intervention
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism, Naturalistic developmental behavioral intervetion, Intervention

Eligibility Criteria

16 Months - 30 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

STAR intervention group

community intervention group

Arm Description

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.

This group will have community interventions parents can choose.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 11, 2023
Last Updated
July 5, 2023
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05901558
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
December 30, 2026 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Therapy
Keywords
Autism, Naturalistic developmental behavioral intervetion, Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STAR intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
community intervention group
Arm Type
Other
Arm Description
This group will have community interventions parents can choose.
Intervention Type
Behavioral
Intervention Name(s)
Strategies for Toddler ASD with Remote-therapy (STAR)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Community intervention
Intervention Description
Regular community intervention
Primary Outcome Measure Information:
Title
Change of Communication and Symbolic Behavior Scales Developmental Profile(CSBS)
Description
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 Outcome Measure Information:
Title
Autism Diagnostic Observation Schedule-Second edition(ADOS-2)
Description
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)
Title
Parenting Stress Index/Short Form (PSI/SF)
Description
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)
Title
The Griffiths Mental Development Scales (GMDS)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Months
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiong Xu, PhD
Phone
02164931275
Email
xuqiong@fuda.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chunchun Hu, MD
Phone
15721445658
Email
14211240007@fudan.edu.cn
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiong Xu, PhD
Email
stellaxuqiong@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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