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临床试验/NCT07571434
NCT07571434已完成不适用

Piloting Clinic-based Unstuck and On Target in Ecuador

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月8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
20
试验地点
1
主要终点
Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

研究概览

简要总结

The goal of this clinical trial is to learn about the effects of the Spanish-language intervention, Unstuck and On Target (SL-Unstuck), in Spanish-speaking families in Ecuador of children 8-11 years old with attention deficit hyperactivity disorder (ADHD) or autism. The main objectives of this study are:

  • To assess the feasibility and acceptability of SL-Unstuck in Ecuador.
  • Compare SL-Unstuck child and caregiver outcomes to waitlist controls in Ecuador.

Researchers will compare families who are randomized to receive the intervention for 8 weeks to a waitlist control for 8 weeks prior to receiving the intervention.

Participants will:

  • Complete pre- and post- intervention measures
  • Receive the Spanish-language Unstuck and On Target intervention for 8 weeks
  • Participate in focus group to gather qualitative feedback

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 8-11-years old
  • Meet DSM-5 criteria for Autism Spectrum Disorder and/or Attention deficit hyperactivity disorder (ADHD)
  • Verbal skills of 7-years-old or greater as measured on the WISC-V Vocabulary subtest
  • Caregiver endorsement of at least one specified executive functioning problem
  • Caregiver must be at least 18 years old
  • Caregiver must identify their preferred/primary language as Spanish

排除标准

  • Child does not meet criteria for age, diagnosis, verbal language skills, or parent endorsement of EF difficulties
  • Caregiver does not meet criteria or age or preferred language

研究组 & 干预措施

Unstuck

Experimental

干预措施: Spanish-Language Unstuck and On Target (SL-Unstuck) (Behavioral)

Waitlist

No Intervention

结局指标

主要结局

Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)

时间窗: At baseline and again at post-intervention appointment about 10 weeks later

Executive Function Challenge Task (EFCT)

时间窗: At baseline and again at post-intervention appointment about 10 weeks later

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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