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临床试验/NCT07840586
NCT07840586已完成不适用

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

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2021年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
试验地点
1
主要终点
Early Start Denver Model (ESDM) Curriculum Checklist

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Months 至 36 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

ESDM Intervention

干预措施: Early Start Denver Model (Behavioral)

Control

结局指标

主要结局

Early Start Denver Model (ESDM) Curriculum Checklist

时间窗: 7 months

次要结局

  • Vineland-3(7 months)
  • Parent Skill Acquisition Checklist(7 months)
  • Joint Engagement Rating Inventory(7 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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