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CompletedNCT07840586Updated Sep 25, 2026

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 in Autism Spectrum Disorder, sponsored by National University Hospital, Singapore. Completed at 1 site in Singapore. Open to participants aged 12 Months to 36 Months. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by National University Hospital, Singapore · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
58
Ages
12 Months to 36 Months
Sex
All
01

Study 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. 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

1) 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

02

Conditions studied

  • Autism Spectrum Disorder
03

Who can participate

Ages eligible
12 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children referred to the National University Hospital Child Development Unit

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
58 participants (actual)
Patient registry
No

Groups and cohorts

  • ESDM Intervention

    Behavioral: Early Start Denver Model

  • Control

Interventions

  • BehavioralEarly Start Denver Model

    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.

05

What researchers measure

Primary outcomes

  1. Early Start Denver Model (ESDM) Curriculum Checklist

    Time frame: 7 months

Secondary outcomes

  1. Vineland-3

    Time frame: 7 months

  2. Parent Skill Acquisition Checklist

    Time frame: 7 months

  3. Joint Engagement Rating Inventory

    Time frame: 7 months

06

Study locations

1 site
  • National University Hospital Child Development Unit
    Singapore, Singapore
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07840586
Lead sponsor
National University Hospital, Singapore
Responsible party
Sponsor
First posted
Sep 25, 2026
Start date
Dec 9, 2021
Primary completion
Sep 15, 2023
Completion
Sep 15, 2023
Last update
Sep 25, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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