NCT05970991

Brief Summary

Healthcare providers' implicit bias has been identified as a contributor to longstanding health inequities via negative impacts on the patient-clinician relationship and biased delivery of high-quality evidence-based practices (EBP). The implementation of any EBP runs the risk of worsening existing health disparities due to inequitable access, delivery, or benefit of the intervention. Clinician bias can be a critical and unaddressed determinant of implementation for any EBP. Although some implicit bias interventions for healthcare providers are emerging, studies have rarely included mental health professionals. In a previously NIMH funded project, our research team iteratively developed a brief (\~45 minutes), interactive online Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT) for school mental health clinicians with promising preliminary findings. The current study will test the effectiveness of VIBRANT-an implementation strategy for promoting equitable adoption, penetration, fidelity, and sustainment of EBPs. One highly learnable, efficient, and scalable EBP that is particularly well-suited for the education sector is Measurement-Base Care (MBC)-the systematic collection of patient-reported progress data to inform clinical decision-making. The proposed study aims to (1) evaluate VIBRANT's feasibility to promote equitable adoption, penetration, fidelity, and sustainment of MBC, with a validated, brief, interactive online training for MBC; (2) examine VIBRANT's impact on proximal mechanisms of change including clinicians' implicit bias as well as distal youth mental health outcomes (i.e., symptoms and functioning) with Black and Latinx youth, and (3) assess feasibility of research procedures for a future large-scale efficacy trial.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

January 3, 2023

Last Update Submit

March 9, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • Adoption of Measurement-Based Care (MBC) strategies

    Clinicians will complete weekly caseload service logs, that document whether each of the 3 core MBC practices (i.e., measure administration, clinician reviewing results, discussing results with patient to support collaborative treatment planning) were used with each identified patient in their caseload. MBC adoption (client level) will be a binary measure for each youth on the clinicians' caseload-evidence of any MBC practice will be considered adoption. This is a longitudinal outcome that will be collected on a weekly basis to allow for the observation of growth over time.

    4-month (follow-up 2)

  • Penetration or saturation of Measurement-Based Care (MBC) strategies use

    Clinicians will complete weekly caseload service logs, that document whether each of the 3 core MBC practices (i.e., measure administration, clinician reviewing results, discussing results with patient to support collaborative treatment planning) were used with each identified patient on their caseload. MBC penetration will be derived from dividing the number of youths on the clinician's caseload who is receiving any MBC practices by the total number of youths on the caseload, which should yield a percentage score.

    4-month (follow-up 2)

  • Sustainment of Measurement-Based Care (MBC) strategies use

    Clinicians will complete weekly caseload service logs, that document whether each of the 3 core MBC practices (i.e., measure administration, clinician reviewing results, discussing results with patient to support collaborative treatment planning) were use with each identified patient on their caseload. MBC sustainment will be indicated by the change in MBC penetration at 1 months post-training (Follow-Up 1) and 3 months post-training (Follow-Up 2).

    4-month (follow-up 2)

  • Fidelity of Measurement-Based Care (MBC) Strategies use

    Clinicians will complete weekly caseload service logs, that document whether each of the 3 core MBC practices (i.e., measure administration, clinician reviewing results, discussing results with patient to support collaborative treatment planning) were used with each identified patient on their caseload. Fidelity will be measured by percentage of a clinician's caseload with whom all 3 MBC core components were reported on their caseload service logs.

    4-month (follow-up 2)

  • Change in Clinician's Implicit Association Test (IAT) Scores

    The Implicit Association Test (IAT), the most well-established measure of implicit racial attitudes with over 20 years of empirical support, is a computer-based reaction time task that measures the relative strength of association between pairings of two groups with two evaluative attributes (e.g., White-good and Black-bad vs White-bad and Black-good). The difference in reaction time between the two pairings would reveal the respondent's relative bias. Clinicians will complete 4 distinct IATs (via the online surveys) at each data collection timepoint. The IATs will measure (1) implicit prejudice toward Black (2) and Latinx youth (both in comparison to White youth), (3) implicit stereotyping of Black youth as aggressive compared to White youth (peaceful), and (4) implicit stereotyping of Latinx youth associated with academic failure and White youth with academic success.

    0-months (Pre-training), 1-month (post-training), 2-month follow-up 1, and 4-month (follow-up 2)

  • Change in Clinician and Youth Working Alliance Inventory--Short Form scores

    Working Alliance Inventory--Short Form is a 12-item clinician- and patient-report rating scale of the therapeutic relationship with items that capture agreement on the goals and tasks of therapy as well as the therapeutic bond. It has been validated for use with youth 11-18 years old, demonstrating excellent internal consistency (α = 0.93 to 0.96) for both youth and clinician rating forms, and evidencing a single factor structure.

    1-month (post-training), 4-month (follow-up 2)

  • Change in Strengths and Difficulties Questionnaire (SDQ) youth and caregiver report scores

    The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self- and informant-reported symptom questionnaire that has been validated for use with youths ages 4-18 (self-report for 11-18+) with 5 subscales (emotional distress, conduct problems, attention, peer relationships, prosocial behaviors). Internal consistency for these subscales is adequate, ranging from α = .78 to .82. An additional 5 items comprise an "impact scale" that assesses the degree to which youth's symptoms interfere with different domains of functioning. The impact and prosocial subscale scores will serve as our measures of functional impairment. The SDQ has demonstrated strong psychometrics in large-scale studies with US and international samples and has been shown to be sensitive to treatment change. Spanish versions have been validated with evidence of similar factor structure, measurement invariance, and adequate internal consistency for both youth and parent report, α = .71 to .75.

    1-month (post-training), 4-month (follow-up 2)

Study Arms (2)

MBC Controls

ACTIVE COMPARATOR

Control group clinicians will complete the Brief Online Training (BOLT) for Measurement-Based Care (MBC) and consultation packages (4 online training modules supported by two 1-hour long, live post-training consultation sessions and expert-facilitated asynchronous online discussion board).

Behavioral: Brief Online Training (BOLT) for measurement-based care (MBC)Behavioral: Live Post-Training ConsultationBehavioral: Asynchronous Discussion Board

MBC + VIBRANT

EXPERIMENTAL

Experimental condition clinicians will complete the same online training modules for MBC (BOLT) as the control group, but also complete the Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT) module (45 minutes). They will also receive two 1-hour long, live post-training consultation sessions and expert-facilitated asynchronous online discussion board.

Behavioral: Brief Online Training (BOLT) for measurement-based care (MBC)Behavioral: Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT)Behavioral: Live Post-Training ConsultationBehavioral: Asynchronous Discussion Board

Interventions

Brief Online Training (BOLT) for measurement-based care (MBC) is a series of 4 interactive, self-paced, online training modules that takes approximately 75 - 120 minutes to complete. Clinicians are trained on the core functions, procedures, and best practice approaches for delivering MBC in the school mental health setting. MBC is the systematic collection of patient-reported data to support collaborative clinical decision-making from intake to termination.

MBC + VIBRANTMBC Controls

The Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT) is a brief (45-minute), self-paced, interactive online training module designed to help school-based mental health clinicians understand and manage their implicit bias in clinical interactions.

MBC + VIBRANT

Two 1-hour long small group consultation sessions with an expert consultant designed as additional opportunities to support knowledge elaboration and skills generalization.

MBC + VIBRANTMBC Controls

An expert facilitated online Discussion Board for additional opportunities of knowledge clarification, practice reinforcement, and community building to support implementation sustainment.

MBC + VIBRANTMBC Controls

Eligibility Criteria

Age11 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participating clinicians must…
  • Provide school-based mental health services in middle and high school settings for at least 50% of their clinical deployment.
  • Provide on-going 1:1 mental health services to students (e.g., not assessment only).
  • Have a caseload (who is receiving on-going care) that consists of at least 20% of Black or Latinx students.
  • Participating youths must…
  • Identify as Black/African American or/and Hispanic/Latina/Latino/Latinx
  • be entering into ongoing treatment with a participating clinician in the school mental health setting
  • Participating caregivers must… a. be a primary caregiver to the youth who can answer questions about the youth's daily behaviors and emotional well-being

You may not qualify if:

  • School-based mental health clinicians
  • Clinician who previously participated in a measurement-based care (MBC) related study with our team and have already been exposed to our online MBC training.
  • Clinicians who have participated in a previous study related to VIBRANT.
  • Black \& Latinx youth
  • Youths with a developmental or learning disability that would interfere with their ability to accurately give informed consent or assent and reliable completion of study assessments.
  • Youths who do not speak English or Spanish
  • Caregivers
  • Caregivers who do not reside with the youth or would otherwise have adequate daily contact to report on the youth's typical behaviors and/or emotional well-being.
  • Caregiver who do not speak English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98115, United States

RECRUITING

Related Publications (3)

  • Bhatty GB. Subdural haematoma: an evaluation of treatment methods. J Indian Med Assoc. 1996 Jan;94(1):7-10.

    PMID: 8776032BACKGROUND
  • Sampson BK, Doran KA. Health needs of coronary artery bypass graft surgery patients at discharge. Dimens Crit Care Nurs. 1998 May-Jun;17(3):158-64; quiz 165-8. doi: 10.1097/00003465-199805000-00009.

    PMID: 9633346BACKGROUND
  • Garcia-Segura LM, Rodriguez JR, Torres-Aleman I. Localization of the insulin-like growth factor I receptor in the cerebellum and hypothalamus of adult rats: an electron microscopic study. J Neurocytol. 1997 Jul;26(7):479-90. doi: 10.1023/a:1018581407804.

    PMID: 9306246BACKGROUND

MeSH Terms

Conditions

Bias, Implicit

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehavior

Study Officials

  • Freda Liu, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Freda Liu, PhD

CONTACT

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
Assistant Professor: Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

January 3, 2023

First Posted

August 2, 2023

Study Start

September 1, 2022

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations