Precision-Based Approach to Matching Evidence-Based Interventions to Students With Externalizing Behaviors (SIMSRCT)

March 1, 2023 updated by: Yanchen Zhang, University of Iowa

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota-Twin Cities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment: Student Intervention Matching System
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).
The Student Intervention Matching System (SIMS) is a pre-intervention matching assessment following the behavioral consultation model. The SIMS entails three steps to sequentially assess and then match students' individual characteristics to precise acquisition- or performance-based interventions. The 1st step corresponds to the "problem identification" stage in behavioral consultation. The 2nd step corresponds to the "problem analysis" stage of behavioral consultation.The 3rd step of SIMS corresponds to the "implementation planning" and "evaluation" stages of behavioral consultation.
Active Comparator: Active control: group-based social skills training
In the control condition, students received an unconditionally mismatched acquisition-based EBI (group-based social skills training).
In the control condition, students received an unconditionally mismatched acquisition-based intervention (group-based social skills training). We selected group-based social skills training for four reasons: (a) participating schools had already been delivering it as their treatment-as-usual, (b) it is a common intervention in US schools, (c) it is only effective for students with acquisition needs, and (d) it represents a counterfactual contrast to the treatment condition because externalizing behaviors driven by performance needs will be reduced more by performance-based interventions than acquisition-based ones.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the frequency of students' externalizing behaviors from baseline to 10-week follow-up
Time Frame: 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".
Start of the study (baseline) and End of the study (10-week posttest)
Change in the severity of students' externalizing behaviors from baseline to 10-week follow-up
Time Frame: 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.
Start of the study (baseline), and End of the study (10-week posttest)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and Acceptability
Time Frame: End of the study (10-week posttest)
The school teams and designated implementers of matched EBIs rated the feasibility and acceptability of the EBIs matched via SIMS. Given the scope of this study, we used two subscales, Feasibility (7-item) and Acceptability (9-item), from the Usage Rating Profile-Intervention Revised (URP-IR; Chafouleas et al., 2011). All items were rated on a 6-point Likert scale ranging from 1 "strongly disagree" to 6 "strongly agree".
End of the study (10-week posttest)
Intervention Fidelity
Time Frame: End of the study (10-week posttest)
The designated implementers of matched EBIs (e.g., teachers, paraprofessionals, or behavioral specialists) used EBI-specific checklists to assess their intervention fidelity. Given the scope of this study and the common practice in school-based intervention research, we used implementers' adherence to the EBI protocols as the primary indicator of intervention fidelity. Fidelity checklists were developed by (a) operationalizing the core components of an EBI, and (b) having implementers to self-report how many core components they delivered as intended for the target student during a specific period.
End of the study (10-week posttest)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Chafouleas SM. Direct Behavior Rating: A review of the issues and research in its development. Education and Treatment of Children. 2011;34(4):575-91.
  • Elliott SN, Gresham FM, Frank JL, Beddow III PA. Intervention validity of social behavior rating scales: Features of assessments that link results to treatment plans. Assessment for effective intervention. 2008 Dec;34(1):15-24.
  • Christ TJ, Riley-Tillman TC, Chafouleas SM. Foundation for the development and use of Direct Behavior Rating (DBR) to assess and evaluate student behavior. Assessment for Effective Intervention. 2009 Sep;34(4):201-13.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2018

Primary Completion (Actual)

November 10, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Estimate)

March 3, 2023

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SIMS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified datasets generated and analyzed during the current study are available upon request to the principle investigator.

IPD Sharing Time Frame

From February 1st, 2023 with no ending date.

IPD Sharing Access Criteria

Public upon request to the principle investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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