Addressing Disparities: Evaluating an Executive Functioning Intervention With Spanish-speaking Neurodivergent Children and Their Families in Mexico and Colorado
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Executive Function Challenge Task
研究概览
简要总结
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
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
- Single (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
- 否
入选标准
- •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.
排除标准
- •Individuals will be excluded only if they do not meet one or more of the inclusion criteria listed above.
研究组 & 干预措施
Spanish Langauge Unstuck and On Target (SL-Unstuck)
Participants in this arm will receive SL-Unstuck immediately. The intervention includes 8 weekly 90-minute clinic-based group sessions with parallel groups for children and caregivers.
干预措施: Unstuck and On Target (Behavioral)
Waitlist control
结局指标
主要结局
Executive Function Challenge Task
时间窗: At baseline and 1 month post-implementation.
The Executive Functioning Challenge Task deliberately tests a child's ability to utilize key executive functions like planning and flexibility by presenting scenarios that reveal potential areas of difficulty in their EF skills. The test yields Flexibility and Planning raw scores with a minimum of 0 and maximum of 8. Higher scores indicate greater impairment in executive functioning. A total executive functioning raw score is also calculated as the sum of planning and flexibility scores. Values below represent the change in average raw scores from baseline to post-intervention for participating children. Negative scores represent an overall decrease in executive functioning impairment (better outcome) while positive scores representing an increase in executive functioning impairment (worse outcome) from baseline to post when looking at the condition groups as a whole.
次要结局
- Behavior Rating Inventory of Executive Function Second Edition(At baseline, 1 month and 3 months post-implementation.)
- Flexibility Interference Questionnaire(At baseline and 1 month post-implementation.)
- Caregiver Strain Questionnaire- Short Form 7(At baseline and 1 month post-implementation.)
- Executive Functions Knowledge Questionnaire(At baseline and 1 month post-implementation.)