Clinical trial NCT05240222: Pre-Implementation Enhancement Strategy To Improve Teachers' Intention to Implement Evidence-Based Practices
Official title: A Theory-Informed Pre-Implementation Enhancement Strategy Targeting Mechanisms and Outcomes of Implementation: A Triple-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Disorders
Implementation Science
Adolescent Problem Behavior at School
Healthcare Providers
Keywords: Implementation Science
School Mental Health Services
Healthcare Providers
School Teachers
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Minnesota
First posted: 2022-02-15
Enrollment: 43
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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: 1. 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:
   1. 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?
   2. 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?
   3. Does teachers' intention to implement mediate the association between study condition and intervention fidelity?
   4. Does teachers' intervention fidelity mediate the association between their intentions to implement and class-wide youth behavioral health outcomes?
2. 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.
3. 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.
4. 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.

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.

Primary outcomes:
measure: Change from Baseline Teachers' Intentions to Implement (ITI) at 3 Days
timeFrame: Three days following the baseline test of teachers' intentions to implement
measure: Change from Baseline Teachers' Intervention Fidelity at 6 weeks.
timeFrame: Six weeks following the baseline test of teachers' intervention fidelity
Secondary outcomes:
measure: Change from Baseline Students' Academic Engaged Time (AET) at 6 weeks
timeFrame: Six weeks following the baseline test of students' AET
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Yanchen Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.