Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05240222 |
Other study ID # |
PIES001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 22, 2016 |
Est. completion date |
July 1, 2017 |
Study information
Verified date |
February 2022 |
Source |
University of Iowa |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.