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Completed

NCT Number: NCT07840586

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

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.

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Key information

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital Child Development Unit

Singapore

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

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.

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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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