Autism Spectrum DisorderNCT05901558
Strategies for Toddler ASD With Remote-therapy (STAR) Model for ASD
A study testing Strategies for Toddler ASD with Remote-therapy (STAR) and Community intervention in people with Autism Spectrum Disorder and Therapy, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 months
- Conditions the study is for
- Autism Spectrum Disorder, Therapy
- What is being tested?
- Strategies for Toddler ASD with Remote-therapy (STAR) and Community intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Qiong Xu, PhD, stellaxuqiong@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Therapy
- Being tested
- Strategies for Toddler ASD with Remote-therapy (STAR), Community intervention
- Keywords
- Autism, Naturalistic developmental behavioral intervetion, Intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategies for Toddler ASD with Remote-therapy (STAR)Behavioural
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
Community interventionBehavioural
Regular community intervention
| Study group | Role | What they receive |
|---|---|---|
| STAR intervention group | Experimental | 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. Receives: Behavioral: Strategies for Toddler ASD with Remote-therapy (STAR) |
| community intervention group | Other | This group will have community interventions parents can choose. Receives: Behavioral: Community intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment (T0) to 1 year(T2)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: from enrollment (T0) 1 year(T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start15 Jun 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901558
- Sponsor's protocol ID
- STAR-ASD 1.0
- Status last verified
- Oct 2026
- First submitted
- 11 May 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for Toddler ASD With Remote-therapy (STAR) Model for Early ASD Toddlers: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05901558
- Acronym / sponsor ID
- STAR-ASD 1.0
- Conditions
- Autism Spectrum Disorder, Therapy
- Keywords
- Autism, Naturalistic developmental behavioral intervetion, Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAR intervention group | Experimental | 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. 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. |
| community intervention group | Other | Behavioral: Community interventionThis group will have community interventions parents can choose. |
Who may qualify
- Ages
- 16 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | STAR intervention group |
| Community interventionRegular community intervention | Behavioural | community intervention group |
Primary outcome
Change of Communication and Symbolic Behavior Scales Developmental Profile（CSBS）
Time frame: from enrollment (T0) to 1 year(T2)
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategies for Toddler ASD with Remote-therapy (STAR) and Community intervention in people with Autism Spectrum Disorder and Therapy, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiong Xu, PhD (02164931275, xuqiong@fuda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Communication and Symbolic Behavior Scales Developmental Profile（CSBS） (time frame: from enrollment (T0) to 1 year(T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.