Autism Spectrum DisorderNCT07840586
Acceptability and Efficacy of a Culturally Adapted, Low-Frequency Parent-Mediated Early Start Denver Model (ESDM) Versus Standard Care in Young Children With Autism
An observational study of Autism Spectrum Disorder, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Early intervention is effective in improving developmental outcomes of children on the autism spectrum. However, cultural and contextual factors may influence parental acceptability of treatment models, highlighting a need for culturally adapted models. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Early Start Denver Model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Dec 2021to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Children referred to the National University Hospital Child Development Unit
Who may be able to join
- Children between 12 to 36 months old
- met cut off for the 'moderate-risk' for autism on the M-CHAT-R/F (i.e. post-interview score of 2 - 7, Robins et al., 2014) and had a clinical diagnosis of autism based on DSM-5 criteria following clinical eva and had a luation
- were not receiving any concurrent autism-targeted intervention
Who cannot join
- children with known genetic disorders, very marked delays in gross motor skills, hearing or vision impairments, uncontrolled seizure disorders, as well as significant anxiety or behaviour problems that prevented rapport-building or entry into therapy spaces.
- parents unable to commit to session frequency or their caregivers could not speak or understand the languages spoken by the therapists (i.e., English or Mandarin Chinese)
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University Hospital Child Development Unit
Singapore
About this study
Official title: The Effects and Feasibility of a Parent-implemented Naturalistic, Relational, and Developmental Intervention on Preschoolers at Risk of Autism Spectrum Disorders (ASD)- a Pilot Study
Early intervention is effective in improving developmental outcomes of children on the autism spectrum. However, cultural and contextual factors may influence parental acceptability of treatment models, highlighting a need for culturally adapted models. This study aims to compare the acceptability and effectiveness of a culturally adapted parent-implemented ESDM against a routine-based, eclectic autism intervention.
Read the detailed description
- Compare the changes in scores on the Early Start Denver Model (ESDM) curriculum checklist from the baseline to the final review (Week 26) between the children receive the ESDM therapy and children who attend in-house routine-based therapy program to determine the effectiveness of the ESDM program. 2) For ESDM group, compare the change in the number of therapeutic strategies demonstrated by the parent in the parent-child play interactions as measured by the parent skill acquisition checklist at the baseline, mid-point through the intervention, and end of the intervention. 3) Compare changes in the adaptive scores measured with the Vineland Adaptive Behavior Scales- Third Edition (VABS-III) from baseline to assessment at the end of the intervention between these two groups. 4) Survey parent satisfaction of both treatments and perceptions on the feasibility of the parent-implemented interventions at the end of the intervention for both groups. 5) For both groups, compare changes in the quality of parent-child engagement as measured with the Joint Engagement Rating Inventory (JERI) from the baseline to progress review at the end of the intervention. 6) For both groups, determine the feasibility of the parent implemented intervention framework by assessing parent satisfaction data, clinic attendance rate throughout the intervention, and therapy take-up rate
- Conditions
- Autism Spectrum Disorder
- Being tested
- Early Start Denver Model
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Start Denver ModelBehavioural
The effectiveness of ESDM and parent-mediated ESDM (P-ESDM) has been demonstrated with multiple randomised controlled trials, and meta-analyses indicated moderate positive effects on communication, cognition, and autism symptoms.
| Study group | Role | What they receive |
|---|---|---|
| ESDM Intervention | Not described Receives: Behavioral: Early Start Denver Model | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Start Denver Model (ESDM) Curriculum Checklist
Measured: 7 months
Secondary outcomes (3)
Vineland-3
Measured: 7 months
Parent Skill Acquisition Checklist
Measured: 7 months
Joint Engagement Rating Inventory
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start9 Dec 2021
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
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 National University Hospital, SingaporeThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840586
- Sponsor's protocol ID
- 2021/00407
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Feasibility of a Parent-implemented Naturalistic, Relational, and Developmental Intervention on Preschoolers at Risk of Autism Spectrum Disorders (ASD)- a Pilot Study
- ClinicalTrials.gov ID
- NCT07840586
- Acronym / sponsor ID
- 2021/00407
- Conditions
- Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 25 Sep 2026 (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.
Early intervention is effective in improving developmental outcomes of children on the autism spectrum. However, cultural and contextual factors may influence parental acceptability of treatment models, highlighting a need for culturally adapted models. This study aims to compare the acceptability and effectiveness of a culturally adapted parent-implemented ESDM against a routine-based, eclectic autism intervention.
Detailed description
- Compare the changes in scores on the Early Start Denver Model (ESDM) curriculum checklist from the baseline to the final review (Week 26) between the children receive the ESDM therapy and children who attend in-house routine-based therapy program to determine the effectiveness of the ESDM program. 2) For ESDM group, compare the change in the number of therapeutic strategies demonstrated by the parent in the parent-child play interactions as measured by the parent skill acquisition checklist at the baseline, mid-point through the intervention, and end of the intervention. 3) Compare changes in the adaptive scores measured with the Vineland Adaptive Behavior Scales- Third Edition (VABS-III) from baseline to assessment at the end of the intervention between these two groups. 4) Survey parent satisfaction of both treatments and perceptions on the feasibility of the parent-implemented interventions at the end of the intervention for both groups. 5) For both groups, compare changes in the quality of parent-child engagement as measured with the Joint Engagement Rating Inventory (JERI) from the baseline to progress review at the end of the intervention. 6) For both groups, determine the feasibility of the parent implemented intervention framework by assessing parent satisfaction data, clinic attendance rate throughout the intervention, and therapy take-up rate
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESDM Intervention | – | Behavioral: Early Start Denver Model |
| Control | – | – |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children referred to the National University Hospital Child Development Unit
Key inclusion criteria (3 listed)
- Children between 12 to 36 months old
- met cut off for the 'moderate-risk' for autism on the M-CHAT-R/F (i.e. post-interview score of 2 - 7, Robins et al., 2014) and had a clinical diagnosis of autism based on DSM-5 criteria following clinical eva and had a luation
- were not receiving any concurrent autism-targeted intervention
Key exclusion criteria (2 listed)
- children with known genetic disorders, very marked delays in gross motor skills, hearing or vision impairments, uncontrolled seizure disorders, as well as significant anxiety or behaviour problems that prevented rapport-building or entry into therapy spaces.
- parents unable to commit to session frequency or their caregivers could not speak or understand the languages spoken by the therapists (i.e., English or Mandarin Chinese)
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 |
|---|---|---|
| Early Start Denver ModelThe effectiveness of ESDM and parent-mediated ESDM (P-ESDM) has been demonstrated with multiple randomised controlled trials, and meta-analyses indicated moderate positive effects on communication, cognition, and autism symptoms. | Behavioural | ESDM Intervention |
Primary outcome
Early Start Denver Model (ESDM) Curriculum Checklist
Time frame: 7 months
3 secondary outcomes
Vineland-3
Time frame: 7 months
Parent Skill Acquisition Checklist
Time frame: 7 months
Joint Engagement Rating Inventory
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by National University Hospital, Singapore at 1 site in Singapore.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 25 Sep 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Start Denver Model (ESDM) Curriculum Checklist (time frame: 7 months). 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 25 Sep 2026.