NCT05752942

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2018

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

February 21, 2023

Last Update Submit

March 1, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

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

    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

    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 Outcomes (2)

  • Feasibility and Acceptability

    End of the study (10-week posttest)

  • Intervention Fidelity

    End of the study (10-week posttest)

Study Arms (2)

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).

Behavioral: Student Intervention Matching System (SIMS)

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).

Behavioral: group-based social skills training

Interventions

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.

Treatment: Student Intervention Matching System

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.

Active control: group-based social skills training

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota-Twin Cities

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (3)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

Study Officials

  • Clayton Cook, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: single-level two-arm randomized waitlist-controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 3, 2023

Study Start

August 25, 2018

Primary Completion

November 10, 2018

Study Completion

December 1, 2018

Last Updated

March 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
From February 1st, 2023 with no ending date.
Access Criteria
Public upon request to the principle investigator

Locations