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临床试验/NCT05135728
NCT05135728已完成不适用

Development and Pilot Testing of a Novel Preschool Executive Function Curriculum Development of an Executive Function Intervention for Adolescents With Autism Spectrum Disorders

Children's National Research Institute2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
2
主要终点
Acceptability of Intervention

研究概览

简要总结

Executive function (EF) skills are a set of essential cognitive abilities that enable individuals to demonstrate their knowledge and talents, effectively complete tasks and navigate social interactions through flexible regulation of their thinking, behavior and emotions. EF is strongly linked to academic readiness and long-term educational outcomes. Children's EF is impacted by poverty-related experiences and is also impaired in the increasing number of children with developmental and emotional disabilities. Interventions targeting EF skills hold particular promise for improving children's educational trajectories by leveraging brain plasticity in the preschool period. We will directly target EF skills in preschoolers with poor EF. This project will address a key source of the achievement gap by meeting the needs of children at the highest risk, those who: 1) show early signs of EF impairment; 2) live in low-income communities and 3) are at risk for developmental and emotional disabilities (DD/ED). The intervention is a downward extension of Unstuck and On Target for elementary school (UOT; Cannon, Kenworthy, Alexander, Werner, & Anthony, 2018), an EF intervention shown to be effective at increasing children's learning behaviors, as delivered by school staff. The research team will partner with key stakeholders to revise and iteratively refine UOT-P through a development trial, utilizing participant, teacher and parent feedback. The results of this trial will be leveraged to enable the team to apply for future federal funding for a randomized comparative effectiveness trial (NIH, Institute of Educational Sciences, Patient-Centered Outcomes Research Institute).

研究设计

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

入排标准

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

入选标准

  • Enrolled as a student at a participating school site OR as a patient at a participating clinic site
  • Chronological age between 3-6 years at enrollment
  • English as a primary language
  • Roughly age-appropriate core language skills as determined by referring school staff or provider
  • Identified by school staff or provider as having problems with flexibility

排除标准

  • No longer enrolled at participating school or clinic site
  • Insufficient English fluency or language skills to complete intervention

结局指标

主要结局

Acceptability of Intervention

时间窗: Through study completion, average of 20 weeks

Acceptability will be measured via interventionist ratings on the Acceptability of Intervention Measure (AIM). Scores range from 4-20, where higher scores indicate higher acceptability.

Intervention Appropriateness

时间窗: Through study completion, average of 20 weeks

Acceptability will be measured via interventionist ratings on the the Intervention Appropriateness Measure (IAM) at outcome.

Feasibility of Intervention

时间窗: Through study completion, average of 20 weeks

Interventionist ratings of feasibility will serve as the primary outcome measure. Interventionists will rate overall intervention feasibility using the Feasibility of Intervention Measure (FIM) at outcome. Scores range 4-20, where higher scores indicate higher feasibility.

Feasibility - Child Attendance

时间窗: Through study completion, average of 20 weeks

Child attendance at groups will also be tracked.

次要结局

  • Interventionist Knowledge(baseline, end of intervention - an average of 20 weeks between baseline and end of intervention)
  • Fidelity Observations(twice throughout intervention period, average of 6 weeks between observations)

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Allison Ratto

Psychologist, Center for Autism Spectrum Disorders

Children's National Research Institute

研究点 (2)

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