Problem;Behaviour;ChildSIMSRCTNCT05752942
Precision-Based Approach to Matching Evidence-Based Interventions to Students With Externalizing Behaviors
A study testing Student Intervention Matching System (SIMS) and group-based social skills training in people with Problem;Behaviour;Child, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Problem;Behaviour;Child
- What is being tested?
- Student Intervention Matching System (SIMS) and group-based social skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota-Twin Cities
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
- Conditions
- Problem;Behaviour;Child
- Being tested
- Student Intervention Matching System (SIMS), group-based social skills training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Student Intervention Matching System (SIMS)Behavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: group-based social skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: Start of the study (baseline), and End of the study (10-week posttest)
Secondary outcomes (2)
Feasibility and Acceptability
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".
Measured: End of the study (10-week posttest)
Intervention Fidelity
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.
Measured: End of the study (10-week posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start25 Aug 2018
- Primary completion10 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Problem;Behaviour;ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-level two-arm randomized waitlist-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Yanchen Zhang, University of Iowa
- Investigators
- Clayton Cook, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752942
- Sponsor's protocol ID
- SIMS001
- Acronym
- SIMSRCT
- Status last verified
- Mar 2023
- First submitted
- 21 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified datasets generated and analyzed during the current study are available upon request to the principle investigator.
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 at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision-Based Approach to Matching Evidence-Based Interventions to Individual Needs of Students With Externalizing Behaviors: A Double-Masked Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05752942
- Acronym / sponsor ID
- SIMSRCT / SIMS001
- Conditions
- Problem;Behaviour;Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 25 Aug 2018 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- single-level two-arm randomized waitlist-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment: Student Intervention Matching System | Experimental | Behavioral: Student Intervention Matching System (SIMS)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). |
| Active control: group-based social skills training | Active comparator | Behavioral: group-based social skills trainingIn the control condition, students received an unconditionally mismatched acquisition-based EBI (group-based social skills training). |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Treatment: Student Intervention Matching System |
| group-based social skills trainingIn 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. | Behavioural | Active control: group-based social skills training |
Primary outcome
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".
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.
2 secondary outcomes
Feasibility and Acceptability
Time frame: End of the study (10-week posttest)
Intervention Fidelity
Time frame: End of the study (10-week posttest)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- BackgroundChafouleas SM. Direct Behavior Rating: A review of the issues and research in its development. Education and Treatment of Children. 2011;34(4):575-91.
- BackgroundElliott 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.
- BackgroundChrist 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.
- Individual participant dataSharing planned: Yes. The de-identified datasets generated and analyzed during the current study are available upon request to the principle investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clayton Cook, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Student Intervention Matching System (SIMS) and group-based social skills training in people with Problem;Behaviour;Child, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752942, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.