- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05752942
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota-Twin Cities
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-
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)
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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.
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Start of the study (baseline), and End of the study (10-week posttest)
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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".
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End of the study (10-week posttest)
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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.
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End of the study (10-week posttest)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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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