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临床试验/NCT07276750
NCT07276750招募中不适用

Coaching and Leadership in Autism Support Settings

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 373 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
373
试验地点
1
主要终点
Reported Externalizing Behavior - SESBI-R

研究概览

简要总结

Schools serve a large number of autistic children, yet face two critical gaps that stifle the delivery of evidence-based practices: 1) an intervention gap characterized by limited availability of evidence-based practices educators can use to address externalizing behaviors when they occur in the classroom; and 2) an implementation gap consisting of insufficient evidence-based practice fidelity and sustainment over time. To address these gaps, this project proposes a hybrid type 2 effectiveness-implementation trial that simultaneously tests: 1) the clinical effectiveness of an efficient, educator-delivered clinical intervention to reduce autistic children's externalizing behaviors (Research Units in Behavioral Interventions in Educational Settings; RUBIES), and 2) the implementation effectiveness of an organizational implementation strategy designed specifically to enhance sustainment of evidence-based practices in public schools (Helping Educational Leaders Mobilize evidence; HELM). Consistent with the National Institute of Mental Health (NIMH)'s experimental therapeutics approach, the project also examines the mechanisms through which RUBIES impacts clinical outcomes and through which HELM influences implementation outcomes. The proposed study directly responds to high priority research areas of the US Department of Health and Human Services Interagency Autism Coordinating Committee's Strategic Plan for Autism Research, which calls for expanded research on the translation of proven-efficacious interventions into the community, NIMH Strategic Priority 3.3 to test interventions for effectiveness in community practice settings, and NIMH Strategic Priority 4.2 to expedite adoption, sustained implementation, and continuous improvement of evidence-based mental health services. If successful, this study will have substantial public health impact because it will produce an effective intervention for a prevalent problem among a high impact population in schools across the United States of America and will determine how to sustain this (and other) intervention(s) with high fidelity, to the betterment of health.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Special or general education teachers, paraeducators, and other staff who provide direct instruction and/or behavioral support to autistic children during the school day (e.g., speech therapist, school psychologist).
  • Autistic children with:
  • a documented autism spectrum disorder diagnosis via school records (i.e., Individualized Education Program; IEP)
  • are enrolled with a participating educator
  • are in grades K-5
  • ages 5-12
  • Sutter Eyberg Student Behavior Inventory-Revised (SESBI-R) total score >=101
  • EDI sum score of >=8 at baseline

排除标准

  • SESBI-R total score <101 (i.e. T score 51+)
  • EDI sum score <8

研究组 & 干预措施

RUBIES + HELM

Experimental

干预措施: RUBIES (Other)

RUBIES + HELM

Experimental

干预措施: HELM (Other)

RUBIES

Experimental

干预措施: RUBIES (Other)

Psychoeducation

Active Comparator

干预措施: Educator Psychoeducation (Other)

结局指标

主要结局

Reported Externalizing Behavior - SESBI-R

时间窗: Baseline to 24 weeks after baseline

The Sutter Eyberg Student Behavior Inventory-Revised (SESBI-R) is a teacher-report measure used to assess conduct problems in youth ages 2-16. It contains 38 items where teachers are able to indicate the current frequency of behavior problems (Never to Always) and determine whether or not they find the behaviors to be problematic.

Reported Externalizing Behavior- EDI

时间窗: Baseline to 24 weeks after baseline

The Emotion Dysregulation Inventory (EDI) is a questionnaire that assesses emotion regulation and is validated for youth with autism spectrum disorder (ASD). Response options are on a 5-point Likert scale from "not at all" to "very severe" for observed functioning over the past 7 days.

RUBIES Fidelity

时间窗: Baseline to 16 weeks after baseline

Educator Homework Completion is rated by the coach after the completion of each module, with evaluation focused on three domains, each evaluated on a 4-point scale: 1) homework data collection , 2) correct implementation, and 3) frequency. Homework Completion is then calculated as the sum of coach ratings across the 3 domains/12 (total possible score). Educator Behavior Support Plan (BSP) Implementation is rated by the Coach after the completion of each module on a scale of 1-8 (1=none of the components of the BSP are implemented; 4=BSP is partially implemented and with some implementation errors; 8=The BSP is implemented consistently and effectively in its entirety). BSP Implementation is calculated as a proportion: sum of coach ratings/12 (total possible score). These measures allow for a calculation of educator weekly as well as total average Homework Completion and BSP implementation across the course of RUBIES

次要结局

  • Sustainment(52 and 76 weeks after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jill Locke, PhD

Associate Professor in Residence

University of California, Los Angeles

研究点 (1)

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