NCT03791281

Brief Summary

The goal of this study is to adapt and test the feasibility and potential efficacy of a theory-driven pre-implementation intervention to address individual-level barriers to EBP implementation - Beliefs and Attitudes for Successful Implementation in Schools (BASIS) - designed to improve school mental health providers' implementation of EBPs. BASIS is intended to be a feasible and scalable first-line or adjunctive implementation enhancement intervention that is facilitative of other efforts (e.g., organizational interventions) that target high quality EBP implementation. Aims of this study are to: (1) Adapt an existing, theory-driven implementation intervention (BASIS), previously used with educators, to improve the EBP implementation behaviors of school mental health providers; and (2) Assess the viability of a later clinical trial by: (a) establishing the feasibility, acceptability, and appropriateness of the BASIS intervention among school mental health providers, and (b) Pilot testing BASIS, as compared to an Attention Control, delivered as pre-implementation intervention prior to training in a specific, existing EBP. Key organizational factors (e.g., implementation climate) will also be evaluated and included as covariates and we will explore trends in the data to inform the design of a larger trial. Ultimately, BASIS offers an innovative and scalable approach to improving school mental health providers' uptake and use of EBPs in order to increase the number of youth with mental health problems who receive high quality services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

August 15, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

December 21, 2018

Last Update Submit

December 29, 2018

Conditions

Keywords

pre-implementation interventionimplementation strategyindividual-level barriers

Outcome Measures

Primary Outcomes (3)

  • Change in Attitudes toward Evidence-Based Practices

    Evidence-Based Practice Attitudes Scale (EBPAS) is a widely used 26-item tool designed to assess evidence-based practice (EBP) attitudes with items measured on a 0-4 scale and 6 subscales: (1) likelihood of adopting if the EBP were a requirement; (2) likelihood of adopting if the EBP were appealing to you; (3) openness to new practices; (4) perceived divergence between current practices and EBPs; (5) fit of EBPs with current practices; and (6) burden of EBPs. Subscale and total scores are mean scores of items with a range of 0-4. Higher scores reflect more favorable attitudes (perceived divergence is reverse-coded).

    Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up

  • Change in Subjective Norms

    Subjective Norms Scale is based on Theory of Planned Behavior (TPB) constructs. Two subscales measure two types implementation-related subjective norms: injunctive norms and descriptive norms. Four items load on each subscale and mean score range from -3 to +3, with positive scores reflecting more positive subjective injunctive and descriptive norms.

    Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up

  • Change in Perceived Behavioral Control

    Perceived Behavioral Control Scale is a modified version of the Teacher's Self-Efficacy Scale, which has 10 items assessing perceived behavioral control in implementing evidence-based practices. Items are scored on a 1-4 scale with a total mean score ranging from 1-4. Higher scores reflect greater (i.e., more favorable) perceived behavioral control.

    Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up

Secondary Outcomes (2)

  • Change in School Implementation Citizenship Behaviors

    Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up

  • Change in Intentions to Implement

    Pre-intervention/baseline, post-intervention (1-2 weeks), 4-month follow-up

Study Arms (2)

BASIS

EXPERIMENTAL

Received a 3-hour BASIS implementation strategy.

Behavioral: BASIS

Attention Control

ACTIVE COMPARATOR

Received a 3-hour session designed to control for dose, information provided, and presenter effects.

Behavioral: Attention Control

Interventions

BASISBEHAVIORAL
BASIS
Attention Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • School mental health providers (school psychologists, school social workers, etc.) recruited from middle and high schools in two economically and ethnically diverse districts in the Seattle area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington School Mental Health Assessment, Research, and Training (SMART) Center

Seattle, Washington, 98115-8160, United States

Location

Related Publications (1)

  • Lyon AR, Cook CR, Duong MT, Nicodimos S, Pullmann MD, Brewer SK, Gaias LM, Cox S. The influence of a blended, theoretically-informed pre-implementation strategy on school-based clinician implementation of an evidence-based trauma intervention. Implement Sci. 2019 May 30;14(1):54. doi: 10.1186/s13012-019-0905-3.

Study Officials

  • Aaron R Lyon, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, School of Medicine: Psychiatry: Childrens Division

Study Record Dates

First Submitted

December 21, 2018

First Posted

January 2, 2019

Study Start

August 15, 2016

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

January 2, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations