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临床试验/NCT05752942
NCT05752942已完成不适用

Precision-Based Approach to Matching Evidence-Based Interventions to Individual Needs of Students With Externalizing Behaviors: A Double-Masked Randomized Controlled Trial

University of Iowa1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年8月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Change in the frequency of students' externalizing behaviors from baseline to 10-week follow-up

研究概览

简要总结

Although prevalent across schools in the US, the "One-Size-Fits-All" (OSFA) approach to selecting evidence-based interventions (EBIs) for student externalizing behaviors often yields lackluster outcomes, due to the mismatch between the EBI and students' heterogeneous needs. Emerging literature highlighted the promise of the precision approach to intervention (e.g., Student Intervention Matching System; SIMS), whereas EBIs were selected based on the match between a student's individual needs and the active components of EBIs. This pilot study tested the efficacy, feasibility, and acceptability of SIMS to match EBIs to students with externalizing behaviors. The investigators ran a double-masked randomized waitlist-controlled trial in a diverse urban district. Students at risk for externalizing behaviors were recruited and randomly assigned to the treatment (EBIs matched via SIMS) or control condition (mismatched social-skill training). Students received EBIs based on assigned condition for 10 weeks. Students' externalizing behaviors were assessed via a multi-method approach at baseline and 10-week posttest. Teachers rated the feasibility and acceptability of SIMS at 10-week posttest. The investigators used cluster-adjusted ANCOVAs to compare efficacy of matched EBIs via SIMS against that of the mismatched social skill training in reducing student externalizing behaviors.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •with a moderate risk for externalizing behavioral problems, which was indicated by a score between 4 and 8 on the Student Risk Screening Scale-Externalizing.
  • •receiving the majority of services in general education settings
  • •in 3rd, 4th, or 5th grade level.

排除标准

  • •severe risk for externalizing problems, which was indicated by a score exceeding 8 on the Student Risk Screening Scale-Externalizing. The students at severe risk will be referred to the school counselor for appropriate service.

研究组 & 干预措施

Treatment: Student Intervention Matching System

Experimental

In the treatment condition, the students received a performance-based interventions matched to their individual needs and characteristics based on Student Intervention Matching System (SIMS).

干预措施: Student Intervention Matching System (SIMS) (Behavioral)

Active control: group-based social skills training

Active Comparator

In the control condition, students received an unconditionally mismatched acquisition-based EBI (group-based social skills training).

干预措施: group-based social skills training (Behavioral)

结局指标

主要结局

Change in the frequency of students' externalizing behaviors from baseline to 10-week follow-up

时间窗: Start of the study (baseline) and End of the study (10-week posttest)

The Direct Behavior Rating- Multi-Item Scale (DBR-MIS) is a pragmatic and low-inference assessment of an operationally defined problem behavior on a specific dimension (frequency, intensity, or duration of externalizing behaviors; Christ et al., 2009). The educators complete the DBR-MIS based on their observations of the target student in the setting where the problem behavior usually occurs for a pre-specified period. The DBR-MIS contains three items corresponding to disruptive behaviors, aggressive behavior, and noncompliance, which were summed into a total score of externalizing behaviors. Each item was rated on a 10-point Likert scale ranging from "0%; Never" to "50%; Sometimes" to "100%; Always".

Change in the severity of students' externalizing behaviors from baseline to 10-week follow-up

时间窗: Start of the study (baseline), and End of the study (10-week posttest)

The Social Skills Improvement System-Rating Scale (SSIS-RS; Elliott et al., 2008) is a brief and intervention-oriented assessment of students' needs in social skills and problem behaviors. Given the scope of this study, only the "externalizing behavior subscale" were used. Each item was rated on a 3-point Likert scale (0= Never, 1= Seldom, 2 = Often, and 3= Almost Always) based on the frequency of a student's externalizing behavior. High scores indicate more frequent externalizing behaviors.

次要结局

  • Feasibility and Acceptability(End of the study (10-week posttest))
  • Intervention Fidelity(End of the study (10-week posttest))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanchen Zhang

Assistant Professor

University of Iowa

研究点 (1)

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