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Executive Function Play Opportunities for Children With Down Syndrome (EXPO)

2026年8月25日 更新者：Colorado State University

Executive Function Intervention for Young Children With Down Syndrome

The Executive Function Play Opportunities (EXPO) study is a sequential, multiple assignment, randomized trial (SMART) evaluating adaptive caregiver-mediated intervention pathways for improving executive function (EF) in children with Down syndrome (DS). At baseline, participants will be randomized in a 1:4 ratio to receive either a delayed-treatment control condition or the EXPO intervention. After 4 weeks of standard EXPO intervention in stage 1, participants in the EXPO condition will be assessed for response to the intervention based on prespecified criteria for improvement in laboratory-based EF performance. Early responders will continue with the standard EXPO intervention in stage 2. Slower responders will be randomized to either the EXPO Extended or EXPO Foundations pathway. All participants will complete laboratory and parent-report measures of EF immediately post-intervention and 3 months later. Participants in the delayed-treatment control condition will complete the same assessments as the EXPO groups and will be offered the EXPO intervention after completion of the 3-month follow-up.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The Executive Function Play Opportunities (EXPO) study is a sequential, multiple assignment, randomized trial (SMART) evaluating adaptive caregiver-mediated intervention pathways for improving executive function (EF) in children with Down syndrome (DS). At baseline, all participants will complete an assessment including laboratory-based measures of EF, parent-report measures of EF, and intensive ecological measurement of EF using the iBehavior app. Participants will then be randomized in a 1:4 ratio to receive either a delayed-treatment control condition or the EXPO intervention, with a target total sample size of 150.

During stage 1, participants in the EXPO condition will complete 4 weeks of standard EXPO intervention. The initial weeks of EXPO consist of 2 weeks of EXPO Ready activities followed by 2 weeks of Working Memory activities, and all participants in the EXPO intervention receive ongoing support from an EXPO coach.

At the stage 1 evaluation, conducted 4 weeks after starting EXPO, all participants will complete the laboratory-based EF assessment battery. EXPO participants will be assessed for response to the intervention and classified as early or slower responders based on prespecified criteria for improvement in laboratory-based EF performance.

Early responders will be assigned to the standard EXPO intervention in stage 2 and continue with activities targeting inhibition, cognitive flexibility, planning, and consolidation of skills for a total of 12 weeks. Slower responders will be randomly assigned in a 1:1 ratio to either the EXPO Extended or EXPO Foundations pathway. The EXPO Extended pathway will include the same core activities as the EXPO standard pathway but will provide additional intervention time, for a total of 18 weeks. The EXPO Foundations pathway will begin with a block of activities targeting early social communication and regulation to provide a foundation for activity engagement, followed by more foundational versions of activities targeting inhibition and cognitive flexibility. The EXPO Foundations pathway will continue for a total of 12 weeks.

All participants will complete laboratory and parent-report measures of EF immediately post-intervention and 3 months later. Participants in the delayed-treatment control condition will not receive EXPO during the initial study period but will complete the same assessments as participants in the EXPO intervention. Following completion of the 3-month follow-up, participants in the delayed-treatment control condition will be offered the EXPO intervention.

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 意大利
    • CO
      • Padova、CO、意大利、80526
  • 美国
    • Colorado
      • Fort Collins、Colorado、美国、80523
        • Colorado State University
        • 首席研究员：
          • Deborah Fidler, PhD
        • 接触：
        • 接触：
        • 副研究员：
          • Nathaniel Riggs, Phd
        • 副研究员：
          • Susan Hepburn, PhD
        • 副研究员：
          • Lisa Daunhauer, ScD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • confirmed medical diagnosis of Down syndrome

Exclusion Criteria:

  • no complete hearing or vision loss
  • primary exposure to English or Italian

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
无干预：Delayed-Treatment Control
Participants do not receive EXPO during the initial study period and complete the same EF assessments as participants in the EXPO intervention pathways. Participants are offered the EXPO intervention following completion of the 3-month follow-up.
实验性的：EXPO Standard Pathway
Early responders to EXPO at the stage 1 evaluation are assigned to the standard, 12 -week intervention with activities refined from EXPO 2.0.
行为的：EXPO
EXPO is a novel intervention that targets the development of EF through play-based opportunities for children with DS and their primary caregivers. EXPO is a 'syndrome-informed' intervention in that all activities are tailored to phenotypic strengths and challenges associated with DS, accounting for cognitive, language, and motor presentations frequently observed in this population. EXPO is also designed to elicit maximal engagement and enjoyment for children and their caregivers by embedding opportunities to strengthen EF component processes in the context of play and games.
其他名称：
  • Executive Function Play Opportunities
有源比较器：Adaptive Pathway 1/EXPO Extended
Half of participants classified as slower responders to EXPO at the stage 1 evaluation are randomly assigned to EXPO Extended. EXPO Extended provides the standard pathway activities with an extended 18-week schedule.
行为的：EXPO Extended
Alternative EXPO pathway that extends the length of the EXPO intervention from 12 to 18 weeks to provide more time and opportunity for skill acquisition.
有源比较器：Adaptive Pathway 2/EXPO Foundations
Half of participants classified as slower responders to EXPO at the stage 1 evaluation are randomly assigned to EXPO Foundations. EXPO Foundations provides a more foundational pathway with simplified activities, and additional activities that emphasize early communication and regulatory processes.
行为的：EXPO Foundations
An augmented version of EXPO that places a greater emphasis on precursors to EXPO activity engagement, including an increased number of social routine activities, enhanced presses for social communication behaviors like joint attention, enhanced focus on early self-regulation skills, and adaptations of all EXPO activities in each block that emphasize more foundational aspects of play.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Adapted Reverse Categorization
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
Rule switch task that involves sorting by color, and then reversing the sort rule
From enrollment to the end of treatment, with a 3-month follow-up
Zoo Animal Switch
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
Rule switch task that involves sorting large and small animal pairs by size into large and small buckets, then reversing the rule to put large animals into the small bucket, and small animals into the large bucket
From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Cognitive domain
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
Growth Scale Values in the Developmental Profiles-4 Cognitive domain
From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Social-emotional domain
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
Growth Scale Values in the Developemental Profiles-4 Social-Emotional domain
From enrollment to the end of treatment, with a 3-month follow-up

次要结果测量

结果测量
措施说明
大体时间
iBehavior Ecological Momentary Assessment
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
From enrollment to the end of treatment, with a 3-month follow-up
Self ordered pointing: Garage Game
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
Self-ordered pointing task that requires working memory/updating
From enrollment to the end of treatment, with a 3-month follow-up
BRIEF-Preschool Inhibition Domain
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
Standardized Caregiver Report of Executive Functioning for Preschool aged children
From enrollment to the end of treatment, with a 3-month follow-up
Hearts and Flowers
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
Opposites task that involves matching cards to the opposite type of card
From enrollment to the end of treatment, with a 3-month follow-up
Developmental Profiles-4 Adaptive Behavior domain
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
Growth Scale Values in the Developmental Profiles-4 Adaptive Behavior domain
From enrollment to the end of treatment, with a 3-month follow-up
Building Task
大体时间：From enrollment to the end of treatment, with a 3-month follow-up
Shape design task that involves reproducing a pattern of blocks according to a design produced by the examiner
From enrollment to the end of treatment, with a 3-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Colorado State University

合作者

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Los Angeles
University of Southern California
University of Padova

调查人员

  • 首席研究员：Deborah Fidler、Colorado State University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2029年8月31日

研究完成 (估计的)

2029年11月30日

研究注册日期

首次提交

2026年6月17日

首先提交符合 QC 标准的

2026年8月25日

首次发布 (实际的)

2026年8月28日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 7190 (CTEP)
  • R61HD115161 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Upon completion of this study, and annually throughout the thre-year project period, our team will share all developmental and behavioral with the NIH INCLUDE Data Coordinating Center.

Data will also be collected from a parent or guardian via questionnaire and the iBehavior smartphone application. Data that will be preserved and shared include demographic information, developmental assessments composite scores, caregiver rating composite scores for behavioral dimensions, and caregiver-reported iBehavior composite data. The data transformation approach for all aggregate-level data will be specified in detail in a protocol manual for reproducibility. Information regarding data content, format, and organization will be available to any research colleagues accessing the DCC database. All shared data will be formatted in accordance with current standards and norms in the field of

IPD 共享时间框架

Nov 30, 2029

IPD 共享访问标准

Data will be made available within the NIH INCLUDE DCC system, allowing researchers to access it in accordance with their approved access level. All data and secondary analyses will be included in the DCC. The DCC will use its current policies and procedures for access by interested research teams.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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