Spanish-language Executive Function Intervention for Children With Autism and/or ADHD

Официальное название

Evaluating a Spanish-language Executive Functioning Intervention for Children With Autism and/or ADHD and Their Families

Обзор

The goal of this clinical trial is to learn whether the Spanish-language version of Unstuck and On Target (SL-Unstuck), an executive functioning (EF) intervention, is feasible, acceptable, and effective for Spanish-speaking caregivers and their neurodivergent children (ages 8-11) in the U.S.. The main questions it aims to answer are: * Is SL-Unstuck acceptable to Spanish-speaking caregivers and children? * Does SL-Unstuck improve child EF, caregiver EF knowledge, and caregiver strain? Researchers will compare families randomly assigned to immediate SL-Unstuck versus waitlist control to see if participating in the intervention improves EF and family outcomes. Participants will: * Attend 8 weekly SL-Unstuck sessions at a clinic (parallel child and caregiver groups) * Complete pre- and post-intervention assessments on child EF, caregiver strain, and satisfaction * Participate in a focus group to share feedback on the intervention

Вмешательства

• Поведенческое Unstuck and On Target
  Children will receive the Unstuck and On Target (Unstuck) curriculum, a manualized cognitive-behavioral intervention that teaches executive functioning (EF) skills such as flexibility, emotional regulation, and goal-setting. Caregivers will attend concurrent Spanish-language sessions focused on understanding EF challenges and learning strategies to support their child's skills at home. Weekly home practice sheets in Spanish summarize each session and provide practical tips and activities. The pr

Первичные конечные точки

• Executive Function Challenge Task [Срок оценки: At baseline and 1 month post-implementation.]

Вторичные конечные точки (4)

• Behavior Rating Inventory of Executive Function Second Edition [Срок оценки: At baseline, 1 month and 3 months post-implementation.]
• Caregiver Strain Questionnaire- Short Form 7 [Срок оценки: At baseline and 1 month post-implementation.]
• Flexibility Interference Questionnaire [Срок оценки: At baseline and 1 month post-implementation.]
• Executive Functions Knowledge Questionnaire [Срок оценки: At baseline and 1 month post-implementation.]

Критерии участия

Критерии включения

• Child is 8-11 years old.
• Child meets DSM-5 criteria for Autism Spectrum Disorder and/or ADHD
• Child has verbal skills at a 7-year-old level or greater (as measured by WASI Vocabulary and Similarities subtests)
• Caregiver endorses at least one of the following executive functioning problems:
• Difficulty accepting feedback or criticism.
• Difficulty handling frustration.
• Difficulty starting non-preferred activities.
• Frequent meltdowns.
• Not stopping a behavior after being told to stop.
• Shutting down in the face of a challenge.
• Caregiver is at least 18 years old.
• Caregiver identifies Spanish as their preferred or primary language.

Критерии исключения

\- Individuals will be excluded only if they do not meet one or more of the inclusion criteria listed above.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Colorado Anschutz School of Medicine — Aurora

Идентификаторы

NCT: NCT07084324 · 24-1821 · 1K23MH136346-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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