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Completed

NCT Number: NCT05752942

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

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.

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Key information

Conditions

Problem;Behaviour;Child

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota-Twin Cities

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Student Intervention Matching System (SIMS)

Behavioral

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.

group-based social skills training

Behavioral

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.

Primary outcomes

  1. 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".

  2. 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.

Secondary outcomes

  1. 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".

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • University of Minnesota

Registry information

Official study title

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

Acronym: SIMSRCT

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2023
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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