NCT05240222

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

January 10, 2022

Last Update Submit

February 3, 2022

Conditions

Keywords

Implementation ScienceSchool Mental Health ServicesHealthcare ProvidersSchool Teachers

Outcome Measures

Primary Outcomes (2)

  • 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.

    Three days following the baseline test of teachers' intentions to implement

  • 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.

    Six weeks following the baseline test of teachers' intervention fidelity

Secondary Outcomes (1)

  • Change from Baseline Students' Academic Engaged Time (AET) at 6 weeks

    Six weeks following the baseline test of students' AET

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Pre-implementation enhancement strategies (SC-PIES)

Active control

SHAM COMPARATOR

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.

Other: Sham comparator

Interventions

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.

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

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.

Active control

Eligibility Criteria

Age22 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 10163601BACKGROUND
  • 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.

    BACKGROUND
  • 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.

MeSH Terms

Conditions

Child Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Yanchen Zhang, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 15, 2022

Study Start

July 22, 2016

Primary Completion

May 20, 2017

Study Completion

July 1, 2017

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

The de-identified datasets generated and analyzed during the current study are available in the Open Science Framework repository, \[osf.io/d5t4m/\].

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
From December 1st, 2021 with no ending date
Access Criteria
Public upon request to the principle investigator
More information

Available IPD Datasets

Individual Participant Data Set (DOI 10.17605/OSF.IO/D5T4M)Access