跳至主要内容
临床试验/NCT05277194
NCT05277194已完成不适用

Investigating the Impact of an Emotional Stress Alarm App (KeepCalm) on Managing Stress and Preventing Challenging Behaviors in Children With Autism

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2023年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
2
主要终点
Acceptability of Intervention Measure (AIM)

研究概览

简要总结

School-based behavioral approaches to managing challenging behaviors in children with ASD are limited by three key factors: 1) children with ASD often have difficulties communicating their emotions; 2) it is challenging to implement evidence-based, personalized strategies for individual children, and; 3) it is difficult for teachers to track which strategies are successful for individual children. The investigators' personalized mobile-health emotion regulation application (m-health app) will pair heart rate tracking with digital tools to help reduce challenging behavior by supporting stress detection, reminding teachers of specific behavioral strategies and helping teachers to track progress.

详细描述

The project will develop and pilot test a personalized medicine mobile health emotion regulation application (the m-health KeepCalm app) that incorporates physiological stress measurement to support evidence-based practices for reducing challenging behavior in children with autism spectrum disorder (ASD). As much as 80% of children with ASD exhibit challenging behaviors that can have a devastating impact on personal and family well-being, contribute to teacher burnout and require frequent hospitalization. Evidence-based practices for reducing these behaviors emphasize uncovering triggers, yet parents and teachers often report that challenging behaviors surface without warning. Challenging behaviors caused by emotion dysregulation can be the most difficult to predict, as children with ASD often have difficulty communicating their distress before it results in challenging behavior. Exciting recent advances in digital technology now allow measurement of momentary emotion dysregulation, using physiological indices. The investigators' pilot data from four separate samples demonstrate that increased heart rate predicts onset of challenging behavior in children with ASD. In order to tailor the m-health KeepCalm app to end users and avoid potential barriers to its adoption, in Aim 1, the investigators will evaluate the acceptability, feasibility, and appropriateness of app, and the needs of educational teams in managing stress in children with ASD and challenging behaviors, by conducting interviews with teachers of children with ASD, parents of children with ASD and school administrators, and conducting structured in-class observations with teachers. Through the activities of Aim 2, the researchers will improve the m-health KeepCalm app, building on their initial app prototype, in collaboration with their established research partner, the Translational Informatics Unit, Children's Hospital of Philadelphia, and their established community partner, the School District of Philadelphia. The investigators will do this through 1) exploratory work on the specificity of heart rate increase to challenging behavior, on app clinical decision support timing, and on the association of app false positives and negatives to movement or child factors; 2) monthly advisory board meetings with expert stakeholders for app development guidance, and; 3) rapid-cycle prototyping of the app with 10 educational teams (i.e. 1-2 children with ASD, and their teacher and classroom aide, if they have one). This will allow for iterative improvement based on each user's experience. Through Aim 3, the researchers will test the app for usability, acceptability, feasibility and appropriateness, as well as preliminary effectiveness with 30 educational teams in a randomized waitlist field trial over a 3-month period. Successful completion of these aims will result in a novel m-health app designed to help teachers support emotion regulation, and reduce or prevent challenging behavior in children with ASD, using evidence-based strategies. These activities will lay the foundation for an R01 to evaluate the effectiveness of the m-health KeepCalm app in a full- scale randomized field trial. This proposal aligns with the strategic plan of the Interagency Autism Coordinating Committee, to maximize the potential for technology-based interventions to improve the lives of people with ASD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Preschool or elementary school child with autism along with a parent and teacher and/or classroom aide
  • Child must have challenging behaviors including but not limited to aggression, escape behavior, loud noises, non-compliance, property destruction, rigid/inflexible behavior, self-injury, and transition difficulties
  • Adult participants must have access to an iPhone in order to test the app or be willing to use a provided study iPhone

排除标准

  • Child does not exhibit challenging behaviors

结局指标

主要结局

Acceptability of Intervention Measure (AIM)

时间窗: 3 months post-baseline

The Acceptability of Intervention Measure (AIM) is used to measure the acceptability of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the sum of the items, ranging from 5 to 20, with higher scores indicating greater acceptability of the intervention.

System Usability Scale (SUS)

时间窗: 3 months post-baseline

The System Usability Scale (SUS) measures perceptions of usability of a given system, in this case, the KeepCalm app. The scale consists of 10 items, each rated on a 5-point Likert Scale from 1 ("Strongly disagree") to 5 ("Strongly agree"). Responses are transformed to get a total range of possible values from 0-100, with higher scores indicating higher perceptions of usability. Typically, a score above 68 is regarded as a good score.

Intervention Appropriateness Measure (IAM)

时间窗: 3 months post-baseline

The Intervention Appropriateness Measure (IAM) is used to measure the appropriateness of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the sum of the items, ranging from 5 to 20, with higher scores indicating greater appropriateness of the intervention.

Feasibility of Intervention Measure (FIM)

时间窗: 3 months post-baseline

The Feasibility of Intervention Measure (FIM) is used to measure the feasibility of an intervention. The scale consists of 4 items rated on a 5-point Likert Scale from 1 ("Completely disagree") to 5 ("Completely agree"). The score consists of the sum of the items, ranging from 5 to 20, with higher scores indicating greater feasibility of the intervention.

Qualitative interview

时间窗: 3 months post-baseline

This interview will assess the intervention's usability, appropriateness, feasibility, and acceptability in a qualitative interview format.

次要结局

  • Institute for Basic Research Modified Overt Aggression Scale (IBR-MOAS)(baseline and 3 months post-baseline)
  • Emotion Dysregulation Inventory (EDI)(baseline and 3 months post-baseline)
  • School Situations Questionnaire (SSQ)(baseline and 3 months post-baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验