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临床试验/NCT03362840
NCT03362840Unknown不适用

Integrating the Early Started Denver Model in Israeli Autism Spectrum Disorder Preschools: A Controlled Trial

Bar-Ilan University, Israel1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
59
试验地点
1
主要终点
Change from baseline Mullen Scales of Early Learning (MSEL)

研究概览

简要总结

The current study evaluates the effectiveness of the Early Start Denver Model (ESDM) when integrated in existing community preschools for children with ASD. The study compares developmental gains made a group of children receiving preschool-based ESDM compared to a group of children receiving eclectic interventions in their preschools (treatment as usual).

详细描述

The Early Start Denver Model is a comprehensive treatment model for young children with Autism Spectrum Disorders (ASD), which builds upon behavioral, relationship, play-based and developmental theories and practices. Utilizing the plasticity of the young brain, while managing social attention, employing multi-modal teaching, and tapping into the child's motivation, the ESDM aims to alter the child's developmental trajectories by creating rich and meaningful learning experiences in daily and naturalistic routines. This model focuses on all areas of development, with significant stress on communication, language, social skills, play and imitation. In the ESDM, parents are seen as a main motivational factor for the child, and a focal part in planning and implementing key components of the intervention.

Currently, community preschool settings are the main providers of intervention programs for children with ASD in Israel. The prevalent mode of intervention in these settings is a multi-disciplinary eclectic model, in which professionals from various disciplines deliver intervention comprising several theories and practices. While quite ubiquitous, this type of intervention was shown in previous research as less effective than specialized, comprehensive treatment models.

The ESDM was previously shown efficacious in intensive home-based delivery, and effective as a center-based group model. However, there are currently no studies that assess the effectiveness of the ESDM when integrated in existing community preschool settings. Additionally, previous research in center-based group delivery of the ESDM did not focus on the effects of routine parental involvement in child treatment (when delivered in a preschool setting) on child and parental outcomes. The current study aims to explore the effects of ESDM implementation in community preschool settings, together with incorporation of parents in the treatment process.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children learning in ASD schools with a diagnosis of ASD validated by the Autism Diagnostic Observation Schedule - 2nd edition.
  • •ESDM group: parents who have agreed to participate in weekly joint sessions at the preschool.

排除标准

  • 未提供

研究组 & 干预措施

Early Start Denver Model (ESDM) group

Experimental

The ESDM is a manualized comprehensive treatment model for young children (12-48 months). In the preschool based ESDM, learning objectives are guided by the ESDM curriculum checklist, which includes developmental skills in language, play, motor skills, personal independence, imitation and cognition.

干预措施: Early Start Denver Model (Behavioral)

Eclectic preschool intervention group

Active Comparator

The eclectic approach consists of a combination of methods from several treatment-models. Individualized educational plans are based on multi-disciplinary assessment, and include objectives in several domains - communication, social-skills, play, emotional adjustment, adaptive daily skills, motor skills and cognition. They are presented to parents at the beginning of the year and are reviewed by the staff three times a year.

干预措施: Eclectic preschool intervention (Behavioral)

结局指标

主要结局

Change from baseline Mullen Scales of Early Learning (MSEL)

时间窗: Pre-intervention, 8 months, 20 months

A standardized measure of early development which is administered to children from birth to 68 months of age. The MSEL includes five subscales: receptive language, expressive language, visual reception, fine motor, and gross motor skills, for which a standard T score and age equivalents (AE) are computed, together with a total composite of intellectual ability. Administration time - 30-60 minutes (Mullen, 1995).

Change from baseline Vineland Adaptive Behavior Scales, Second Edition (VABS-II)

时间窗: Pre-intervention, 8 months, 20 months

A structured interview measuring adaptive behavior from birth to adulthood. This measure is divided into 11 sub-scales, clustered into four domains: communication, daily living skills, socialization and motors skills. Standard scores and age equivalents can be obtained from this measure, together with an adaptive behavior composite (ABC). The VABS-II may be administered via a structured interview with the caregiver or teacher, or using a self-report questionnaire filled out by the responder. In the current study, both forms of administration will be used, so that parents will be interviewed by a trained practitioner, and teachers will be given the self-report version of the test. Administration time - 45-60 minutes (Sparrow, Cicchetti \& Balla, 2005).

次要结局

  • Change from baseline Parent Sense of Competence Scale (PSOC)(Pre-intervention, 8 months, 20 months)
  • Change from baseline Parenting Stress Index - Short Form (PSI\SF)(Pre-intervention, 8 months, 20 months)
  • Change from baseline parent-child interaction paradigm(Pre-intervention, 8 months, 20 months)
  • Change from baseline child-staff member interaction paradigm(Pre-intervention, 8 months, 20 months)

研究者

发起方
Bar-Ilan University, Israel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ofer Golan

Prof., PhD

Bar-Ilan University, Israel

研究点 (1)

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