NCT05268796招募中2 期
Randomized Controlled Trial of Telehealth-Enabled Versus In-Person Parent-Mediated Behavioral Treatment for Challenging Behaviors in Children With Autism Spectrum Disorder
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Frequency of challenging behavior
研究概览
简要总结
The purpose of the research is to determine whether parent-mediated behavior therapy for challenging behavior commonly displayed by children with autism spectrum disorder (ASD) can be as effective when delivered via telehealth as when delivered in-person.
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
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is aged 2 years 0 months to 7 years 11 months inclusive
- •Child has a documented diagnosis of ASD
- •Child exhibits at least one form of daily or hourly self-injurious behavior and/or aggressive behavior on the Behavior Problems Inventory - Short Form (BPI-S)71,72
- •Family lives in one of the following counties in New Mexico and Texas: Bernalillo, Santa Fe, Valencia, Sandoval, Torrance, Socorro, Cibola, Los Alamos, El Paso, Hudspeth, Otero, McKinley, San Miguel, Eddy, Chaves, or Dona Ana.
- •Caregiver is comfortable speaking and reading in English
- •The child's caregiver is at least 21 years old
- •The same caregiver is consistently available for one hour per week for a 12-week period in their home with their child between 9am and 7pm Monday through Friday to take part in the research
- •Caregiver is willing to adhere to the study intervention regimen and be willing to have a clinician come into their home for 1 hour per week for 12 weeks
- •Family lives in an area with consistent cell phone coverage
排除标准
- •Caregiver is currently receiving ABA services or direct parent coaching to manage their child's challenging behaviors
- •Child engages in behavior that may inflict moderate to severe damage on the individual or on other people (e.g. biting through the skin, eye gouging, fracturing bones, significant damage to property) with minor or major medical intervention required.
- •Child has a sensory or physical impairment that precludes participation (e.g., epilepsy, vision or hearing impairment) or has a diagnosis of another genetic condition (e.g., fragile X syndrome)
- •Activity restrictions that limit caregiver's ability to respond to their child's challenging behaviors
- •Child has an underlying medical condition that is better treated with medical intervention
- •Child only exhibits pica at a daily or hourly frequency on the BPI-S
- •The caregiver has another child already participating in the study
研究组 & 干预措施
In-person treatment
Active Comparator
干预措施: Behavior therapy (Behavioral)
Telehealth-enabled treatment
Active Comparator
干预措施: Behavior therapy (Behavioral)
Psychoeducation
Placebo Comparator
干预措施: Psychoeducation (Other)
结局指标
主要结局
Frequency of challenging behavior
时间窗: 4 week intervals
In-session observations of challenging behavior
Parenting Stress Index
时间窗: Previous 4 weeks
Severity of parent stress
次要结局
未报告次要终点
研究者
Scott Hall
Professor
Stanford University
研究点 (2)
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