Clinical trial NCT05752942: Precision-Based Approach to Matching Evidence-Based Interventions to Students With Externalizing Behaviors
Official title: Precision-Based Approach to Matching Evidence-Based Interventions to Individual Needs of Students With Externalizing Behaviors: A Double-Masked Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem;Behaviour;Child
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2023-03-03
Enrollment: 51
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-level two-arm randomized waitlist-controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the frequency of students' externalizing behaviors from baseline to 10-week follow-up
timeFrame: Start of the study (baseline) and End of the study (10-week posttest)
measure: Change in the severity of students' externalizing behaviors from baseline to 10-week follow-up
timeFrame: Start of the study (baseline), and End of the study (10-week posttest)
Secondary outcomes:
measure: Feasibility and Acceptability
timeFrame: End of the study (10-week posttest)
measure: Intervention Fidelity
timeFrame: End of the study (10-week posttest)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota-Twin Cities
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Clayton Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.