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Pre-Implementation Enhancement Strategy To Improve Teachers' Intention to Implement Evidence-Based Practices (SC-PIES)

Primary Purpose

Child Behavior Disorders, Implementation Science, Adolescent Problem Behavior at School

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pre-implementation enhancement strategies (SC-PIES)
Sham comparator
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Child Behavior Disorders focused on measuring Implementation Science, School Mental Health Services, Healthcare Providers, School Teachers

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Teachers who have no prior training about Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
  • Teachers who have no prior experience in implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.

Exclusion Criteria:

  • Teachers who have attended more than three training sessions about Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
  • Teachers who have more than one month of experience in implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Theory-informed pre-implementation enhancement strategies (SC-PIES)

    Active control

    Arm Description

    The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based student behavioral management practices and subsequent follow-up consultation. The content of SC-PIES was grounded in three social-cognitive principles: (a) growth mindset, (b) saying-is-believing, and (c) commitment and consistency.

    Participants in the active control condition will meet with school administrators to talk about their work irrelevant to SC-PIES or student behaviors. The meeting lasted for the same duration as the SC-PIES at the same time as those in the treatment condition.

    Outcomes

    Primary Outcome Measures

    Change from Baseline Teachers' Intentions to Implement (ITI) at 3 Days
    The Modified Intentions to Use Scale was adopted to assess the change in teachers' intentions to implement from baseline to immediate post-test. The scale is originally developed from research on practitioners' intention to adhere to measurement-based care and is consistent with the recommendations for assessing behavioral intentions based on the theory of planned behavior (Godin & Kok, 1996). The scale consists of five items on a 7-point Likert scale ranging from "greatly disagree" to "greatly agree". The items were modified to specifically assess teachers' intentions to implement EBPs. The scale showed acceptable reliability and validity in prior research.
    Change from Baseline Teachers' Intervention Fidelity at 6 weeks.
    A team of trained professionals, who were blinded to the random assignment results, conducted structured observations to assess the intervention fidelity, which is operationalized in this study as "adherence to core components of the classroom management practices". The data collection took place at pre-test and 6-week follow-up to allow enough time to detect and compare changes in intervention fidelity. First, during core instructional times, trained observers observed two occasions at pre-test and 6-week follow-up to code the presence or absence of the core components of the evidence-based practices. Immediately following the observations, these observers completed a fidelity rating rubric, which was created by operationalizing three core components of each PCBMs such that observers could reliably observe and rate them. The average of the observation coding and the rubric scores represents each teacher's fidelity.

    Secondary Outcome Measures

    Change from Baseline Students' Academic Engaged Time (AET) at 6 weeks
    AET is defined as "any instance where youths are attending to instruction, watching the teacher or speaker, or concentrating on their classwork". This study will use Direct Behavior Ratings (DBRs) for academic engaged time (AET) with which a teacher observes a youth's AET throughout a predetermined interval. Based on the literature of DBRs, teacher-completed DBRs have strong correlations to Structured Direct Observation in assessing AET (Sanetti, 2009). The DBRs will be completed at pre-test and 6-week follow-up. For comparability across classrooms, each teacher completes DBRs during the reading/language arts block at the same time each day of the week for five randomly selected youths, whose results will be then averaged for that class. This approach has demonstrated adequate reliability and validity to capture class-wide AET in education literature (Sanetti, 2009).

    Full Information

    First Posted
    January 10, 2022
    Last Updated
    February 3, 2022
    Sponsor
    University of Iowa
    Collaborators
    University of Washington, University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05240222
    Brief Title
    Pre-Implementation Enhancement Strategy To Improve Teachers' Intention to Implement Evidence-Based Practices
    Acronym
    SC-PIES
    Official Title
    A Theory-Informed Pre-Implementation Enhancement Strategy Targeting Mechanisms and Outcomes of Implementation: A Triple-Blind Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 22, 2016 (Actual)
    Primary Completion Date
    May 20, 2017 (Actual)
    Study Completion Date
    July 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Iowa
    Collaborators
    University of Washington, University of Minnesota

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: As the most common setting where youth access behavioral health services, the education sector frequently employs training and follow-up consultation as cornerstone implementation strategies to promote the uptake and use of evidence-based practices (EBPs), which are often insufficient to produce desired implementation outcomes (e.g., intervention fidelity) and changes in youth behavioral health outcomes (e.g., reduced externalizing behaviors). There is a need for theoretically-informed pre-implementation enhancement strategies (PIES) that increase the yield of training and follow-up consultation. Specifically, social-cognitive theory explicates principles to inform the design of strategy content and specific mechanisms of behavior change, such as intentions to implement (ITI), to target via a PIES that increase provider to more active implementation strategies. Methods: This triple-blind randomized controlled trial preliminarily examined the efficacy of a pragmatic PIES (SC-PIES) to improve the implementation of universal EBPs in the education sector. Participants were randomly assigned to the treatment (PIES) or active control condition (meeting with administrators). The investigators assessed participants' ITI, intervention fidelity, and youth behavioral health outcome before, immediately after, and six-week following treatment.
    Detailed Description
    Background and study aims: As the most common setting where youth access behavioral health services, the education sector frequently employs training and follow-up consultation as cornerstone implementation strategies to promote the uptake and use of evidence-based practices (EBPs). However, these strategies alone are not sufficient to promote the desired implementation (e.g., intervention fidelity) and youth behavioral health outcomes (e.g., externalizing behaviors). Theory-informed pragmatic pre-implementation enhancement strategies (PIES) are needed to increase the yield of training and consultation. Specifically, social-cognitive theory explicates principles to inform the design of strategy content and specific mechanisms of behavior change (e.g., "intentions to implement"; ITI) to target to increase providers' responsiveness to training and consultation. This triple-blind parallel randomized controlled trial preliminarily examined the efficacy of a pragmatic PIES based on social-cognitive theories (SC-PIES) to improve the implementation and youth outcomes of universal EBPs in schools. Four aims will be examined: As compared to control, does the pre-implementation enhancement strategy based on social-cognitive theories (SC-PIES) significantly improve teachers' implementation intentions to implement PCBM practices at posttest after adjusting baseline and covariates? As compared to control, is receiving SC-PIES associated with significantly improved teachers' intervention fidelity and class-wide youth behavioral health outcome at the 6-week follow-up after adjusting for baseline and covariates? Does teachers' intention to implement mediate the association between study condition and intervention fidelity? Does teachers' intervention fidelity mediate the association between their intentions to implement and class-wide youth behavioral health outcomes? Who can participate? Any teacher who has no prior training about or experience of implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in a school district. No restriction on age, gender, experience, or other demographic variables. What does the study involve? The participating teachers will be randomly assigned to either the treatment (SC-PIES) or active control condition (administrative meeting). The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based PCBM practices and subsequent follow-up consultation. Teachers in the active control condition will meet with their administrators to talk about their work irrelevant to SC-PIES or student behaviors. The investigators assessed teachers' ITI, intervention fidelity, and youth behavioral outcome (academic engagement as an incompatible behavior to externalizing disorders) before treatment, immediately after training, and six weeks afterward. What are the possible benefits and risks of participating? Teachers participating in this study will benefit from expert training and consultation to improve their intentions and skills to implement a set of EBPs to help their students' behavioral problems. No risks to participants were expected based on relevant literature in education and implementation science.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Child Behavior Disorders, Implementation Science, Adolescent Problem Behavior at School, Healthcare Providers
    Keywords
    Implementation Science, School Mental Health Services, Healthcare Providers, School Teachers

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a triple-blind parallel randomized controlled trial. Specifically, teachers from a diverse urban district were recruited and randomly assigned to either the treatment (SC-PIES) or active control condition (administrative meeting). Based on the condition assigned, teachers received the SC-PIES (or met with administrators) before EBP training. The investigators assessed teachers' ITI, intervention fidelity, and youth behavioral outcome (academic engagement as an incompatible behavior to externalizing disorders) before treatment, immediately after training, and six weeks afterward.
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    All personnel involved in this study were masked, including the participating teachers, investigators, trainers who deliver the SC-PIES or meeting, and staff who collected the outcome data.
    Allocation
    Randomized
    Enrollment
    43 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Theory-informed pre-implementation enhancement strategies (SC-PIES)
    Arm Type
    Experimental
    Arm Description
    The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based student behavioral management practices and subsequent follow-up consultation. The content of SC-PIES was grounded in three social-cognitive principles: (a) growth mindset, (b) saying-is-believing, and (c) commitment and consistency.
    Arm Title
    Active control
    Arm Type
    Sham Comparator
    Arm Description
    Participants in the active control condition will meet with school administrators to talk about their work irrelevant to SC-PIES or student behaviors. The meeting lasted for the same duration as the SC-PIES at the same time as those in the treatment condition.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pre-implementation enhancement strategies (SC-PIES)
    Intervention Description
    The SC-PIES was delivered to teachers as a one-hour professional development session immediately before receiving specific training about evidence-based student behavioral management practices and follow-up consultation. SC-PIES content was grounded in three social-cognitive principles: (a) growth mindset, (b) saying-is-believing, and (c) commitment and consistency.
    Intervention Type
    Other
    Intervention Name(s)
    Sham comparator
    Intervention Description
    Participants in the active control condition will meet with school administrators to talk about their work irrelevant to SC-PIES or student behaviors. The meeting lasted for the same duration as the SC-PIES at the same time as those in the treatment condition.
    Primary Outcome Measure Information:
    Title
    Change from Baseline Teachers' Intentions to Implement (ITI) at 3 Days
    Description
    The Modified Intentions to Use Scale was adopted to assess the change in teachers' intentions to implement from baseline to immediate post-test. The scale is originally developed from research on practitioners' intention to adhere to measurement-based care and is consistent with the recommendations for assessing behavioral intentions based on the theory of planned behavior (Godin & Kok, 1996). The scale consists of five items on a 7-point Likert scale ranging from "greatly disagree" to "greatly agree". The items were modified to specifically assess teachers' intentions to implement EBPs. The scale showed acceptable reliability and validity in prior research.
    Time Frame
    Three days following the baseline test of teachers' intentions to implement
    Title
    Change from Baseline Teachers' Intervention Fidelity at 6 weeks.
    Description
    A team of trained professionals, who were blinded to the random assignment results, conducted structured observations to assess the intervention fidelity, which is operationalized in this study as "adherence to core components of the classroom management practices". The data collection took place at pre-test and 6-week follow-up to allow enough time to detect and compare changes in intervention fidelity. First, during core instructional times, trained observers observed two occasions at pre-test and 6-week follow-up to code the presence or absence of the core components of the evidence-based practices. Immediately following the observations, these observers completed a fidelity rating rubric, which was created by operationalizing three core components of each PCBMs such that observers could reliably observe and rate them. The average of the observation coding and the rubric scores represents each teacher's fidelity.
    Time Frame
    Six weeks following the baseline test of teachers' intervention fidelity
    Secondary Outcome Measure Information:
    Title
    Change from Baseline Students' Academic Engaged Time (AET) at 6 weeks
    Description
    AET is defined as "any instance where youths are attending to instruction, watching the teacher or speaker, or concentrating on their classwork". This study will use Direct Behavior Ratings (DBRs) for academic engaged time (AET) with which a teacher observes a youth's AET throughout a predetermined interval. Based on the literature of DBRs, teacher-completed DBRs have strong correlations to Structured Direct Observation in assessing AET (Sanetti, 2009). The DBRs will be completed at pre-test and 6-week follow-up. For comparability across classrooms, each teacher completes DBRs during the reading/language arts block at the same time each day of the week for five randomly selected youths, whose results will be then averaged for that class. This approach has demonstrated adequate reliability and validity to capture class-wide AET in education literature (Sanetti, 2009).
    Time Frame
    Six weeks following the baseline test of students' AET

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Teachers who have no prior training about Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district. Teachers who have no prior experience in implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district. Exclusion Criteria: Teachers who have attended more than three training sessions about Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district. Teachers who have more than one month of experience in implementing Proactive Classroom Behavioral Management Strategies (PCBM) targeting youth behaviors in an urban school district.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yanchen Zhang, PhD
    Organizational Affiliation
    University of Iowa
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The de-identified datasets generated and analyzed during the current study are available in the Open Science Framework repository, [osf.io/d5t4m/].
    IPD Sharing Time Frame
    From December 1st, 2021 with no ending date
    IPD Sharing Access Criteria
    Public upon request to the principle investigator
    IPD Sharing URL
    http://osf.io/d5t4m/
    Citations:
    PubMed Identifier
    10163601
    Citation
    Godin G, Kok G. The theory of planned behavior: a review of its applications to health-related behaviors. Am J Health Promot. 1996 Nov-Dec;11(2):87-98. doi: 10.4278/0890-1171-11.2.87.
    Results Reference
    background
    Citation
    Sanetti LM, Kratochwill TR. Toward developing a science of treatment integrity: Introduction to the special series. School Psychology Review. 2009 Dec 1;38(4):445.
    Results Reference
    background
    PubMed Identifier
    36367633
    Citation
    Zhang Y, Cook CR, Azad GF, Larson M, Merle JL, Thayer J, Pauls A, Lyon AR. A Pre-Implementation Enhancement Strategy to Increase the Yield of Training and Consultation for School-Based Behavioral Preventive Practices: a Triple-Blind Randomized Controlled Trial. Prev Sci. 2023 Apr;24(3):552-566. doi: 10.1007/s11121-022-01464-3. Epub 2022 Nov 11.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    http://osf.io/d5t4m/
    Available IPD/Information Identifier
    DOI 10.17605/OSF.IO/D5T4M
    Available IPD/Information Comments
    The de-identified datasets generated and analyzed during the current study are made available in the Open Science Framework repository, [osf.io/d5t4m/].

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