Acceptability and Efficacy of a Culturally Adapted, Low-Frequency Parent-Mediated Early Start Denver Model (ESDM) Versus Standard Care in Young Children With Autism

NCT07840586 | Completed

• 1 other identifier: 2021/00407
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Early Start Denver Model (ESDM) Curriculum Checklist

  7 months

Secondary Outcomes (3)

• Vineland-3

  7 months

• Parent Skill Acquisition Checklist

  7 months

• Joint Engagement Rating Inventory

  7 months

Study Arms (2)

ESDM Intervention

Behavioral: Early Start Denver Model

Control

Interventions

Early Start Denver Model BEHAVIORAL

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.

ESDM Intervention

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children referred to the National University Hospital Child Development Unit

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital Child Development Unit

Singapore, Singapore

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 25, 2026
• Study Start: December 9, 2021
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

SG (1)