Iterative Redesign of a Multifaceted Implementation Strategy for a School-based Behavioral Skills Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Top Problems Assessment (TPA)
研究概览
简要总结
The increased prevalence of autism spectrum disorder (1 in 36 youth) in the United States along with the exorbitant cost of care of supporting one autistic individual with and without intellectual disability across their lifespan ($2.4 and $1.4 million, respectively) creates a sense of urgency to improve outcomes for autistic youth. Schools are the primary setting in which autistic children receive intervention. Despite a growing array of evidence-based interventions (EBI) such as behavioral management, EBIs often are unavailable in schools due to misalignment of existing implementation strategies (IS) with that setting. Large numbers of IS have been described for the education sector, but there is a dire need to identify the most efficient IS to support use of EBI in resource-strapped public schools. This project will apply the local Discover, Design/Build and Test (DDBT) framework to redesign and pilot a multifaceted IS to support educator use of a behavioral skills EBI for autistic children in public schools.
详细描述
Specifically, this study will test the effects of the newly redesigned Research Units in Behavioral Intervention in Educational Settings (RUBIES) Implementation Strategy in comparison with the unadapted Research Units in Behavioral Intervention (RUBI) Implementation Strategy on DDBT mechanisms (engagement, usability, appropriateness), proximal implementation outcomes (adoption, fidelity, adaptation, reach) and child outcomes (disruptive behavior, functioning, top problems). Compared with the un-adapted RUBI IS, the newly designed implementation strategy RUBIES-Team will lead to:
H3-1: greater RUBIES usability, engagement, and appropriateness; H3-2: greater RUBIES adoption, fidelity, and reach, with fewer reactive adaptations to the RUBIES IS; H3-3: noninferiority on student disruptive behavior in autistic children; and H3-4: more students with improved behavioral outcomes than deterioration or unchanged outcomes across conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elementary School Personnel. Elementary school personnel must be 18+ and employed by the school district and work directly with autistic students at their school. Elementary school personnel with varying levels of experience and training backgrounds will be included. Participants will not be excluded given their gender identity, age, demographics, racial/ethnic background, or past experience.
- •Autistic Children who work with a Elementary School Personnel. To participate, autistic students must be between the ages of 5-12 from a participating public elementary school who: (1) have school documentation of an autism classification which will be confirmed through caregiver provision of documentation of a confirmed ASD diagnosis and a score that is above the mean on either the Emotion Dysregulation Inventory or the Sutter Eyberg Student Behavior Inventory; (2) be enrolled in a Kindergarten-5th grade general or special education classroom and participate in an inclusive classroom setting for a minimum of 10% of their weekly hours (4 hours/week); (3) have a participating educator enrolled that meets the inclusion criteria for Elementary School Personnel
排除标准
- •Students will be excluded from this study if they are not planning to stay in the school or the classroom for the duration of the study. Participants will not be excluded given their gender identity, demographics, racial/ethnic background, or ASD symptomology or behavior.
- •Elementary School Personnel will be excluded if they are not working with an autistic student who meets the inclusion criteria.
研究组 & 干预措施
Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy
Participants in this arm will receive the un-adapted RUBI implementation strategy (i.e., RUBI as usual).
干预措施: Unadapted Research Units in Behavioral Intervention (RUBI) implementation strategy (Behavioral)
RUBI in Educational Settings (RUBIES) implementation strategy
Participants in this arm will receive an adapted version of the RUBI intervention manual that was iteratively redesigned for use in educational settings (i.e., RUBI for Educational Settings; RUBIES)
干预措施: RUBI in Educational Settings (RUBIES)-Team (Behavioral)
结局指标
主要结局
Top Problems Assessment (TPA)
时间窗: Baseline, Week 12, and Week 24
The Youth Top Problems (YTP) assessment is an assessment in which youth and caregivers are asked to list the problems they were most concerned about. Upon completion of the list, respondents are asked to assign a severity rating for each problem by answering the questions: how big of a problem is this for you? (0 = not at all to 10 = very, very much). Respondents are then asked to identify which of the problems listed is the biggest problem right now? Which one is the most important to work on? Then the second and third most important until 3 top problems are identified. The YTP shows excellent concurrence with standardized assessments (Kappa ranging from .78 to .91), while also adding specificity for treatment targets (41% of caregivers-, and 79% of youth-identified top problems were not identified by an item amongst elevated standardized assessment subscales).
Aberrant Behavior Checklist-Irritability Scale (ABC-I)
时间窗: Baseline, Week 12, Week 24
The Aberrant Behavior Checklist-Irritability Scale (ABC-I) is a 15-item, teacher-rated subtest on the ABC. Each item is rated 0-3 with higher scores indicating greater severity.
Implementation Strategy Usability Scale (ISUS)
时间窗: Week 12
Usability will be evaluated with educator report on the 10-item Implementation Strategy Usability Scale (ISUS), which is based closely on the well-validated System Usability Scale. Ratings are on a 1 to 5 scale and yield a total score from 0 to 100. Half the items are reverse scored; higher total scores reflect greater usability. The ISUS has good inter-item consistency (a = .83) and sensitivity. Research has also demonstrated that the original version of the ISUS (the SUS) functions similarly-and yields similar scores-for adults and youth as young as 11 years.
Adoption
时间窗: Baseline, Week 12, and Week 24
Adoption is operationalized as the initiation of a educator first use of RUBIES or RUBI at any point during study participation. These data will be collected from educators.
Reach
时间窗: Baseline, Week 12, and Week 24
Reach will be calculated using adoption data as the number of students with whom educators use RUBIES.
Sutter Eyberg Student Behavior Inventory
时间窗: Baseline, Week 12, and Week 24
The Sutter Eyberg Student Behavior Inventory is a teacher-report measure used to assess conduct problems in youth ages 2-16. It contains 36 items where teachers are able to indicate the current frequency of behavior problems (Never to Always) and determine whether or not they find the behaviors to be problematic.
24-item Emotion Dysregulation Inventory
时间窗: Baseline, Week 12, and Week 24
The Emotion Dysregulation Inventory (EDI) is a questionnaire that assesses emotion regulation and is validated for youth with autism spectrum disorder (ASD). Response options are on a 5-point Likert scale from "not at all" to "very severe" for observed functioning over the past 7 days.
Intervention Appropriateness Measure (IAM)
时间窗: Week 12
Educators will complete the Intervention Appropriateness Measure (IAM), a rigorously developed, pragmatic 4-item instrument with strong good internal consistency (a = .87) and test-retest reliability (a = .87).
Fidelity
时间窗: Week 12
An independent evaluator will rate educators' use of RUBIES for participating autistic children.
次要结局
- Social Responsiveness Scale-2 (SRS-2)(Baseline)
- Clinical Global Impressions (CGI)(Baseline, Week 12, and Week 24)
- Fidelity(Weekly from Week 1 - Week 12)
- Number of participants who complete the Framework for Modifications and Adaptations of Evidence Based Interventions(Baseline, Week 12, and Week 24)
- Reach(Week 12)
- Intervention Appropriateness Measure (IAM)(Week 12)
- Implementation Strategy Usability Scale (ISUS)(Week 12)
- 24-item Emotion Dysregulation Inventory(Baseline, Week 12, and Week 24)
- Adoption(Week 12)
- Aberrant Behavior Checklist-Irritability Scale (ABC-I)(Baseline, Week 12, Week 24)
- Clinical Global Impressions (CGI)(Week 12)
研究者
Jill Locke
Associate Professor, Department of Psychiatry and Behavioral Sciences
University of Washington