Clinical trial NCT05970991: Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT)
Official title: Addressing Clinician Bias to Improve Equitable Implementation of Evidence-Based Practice-Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implicit Bias
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-02
Enrollment: 400
Sex: ALL
Minimum age (years): 11
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Clinician bias constitutes a critical and unaddressed determinant of implementation for any Evidence-Based Practice (EBP). Implicit bias interferes with clinical decision-making and negatively impacts the clinician-patient relationship, leading ethnic/racial minoritized youth to receive suboptimal care resulting in disparate (worse) outcomes compared to their NHW peers. This is a preventable implementation gap (e.g., inequitable adoption, penetration, fidelity, sustainment) that substantially and unjustly limits the reach and public health impact of many of our most well-established EBPs in mental healthcare. This gap is particularly problematic in schools, where access to mental health services is significantly improved for ethnic minority youth, leading to more opportunities for disparate care quality. Despite the established knowledge base on implicit bias and bias reduction strategies, very little research has been done with mental health professionals; our team's previous work constitutes the first studies with mental health providers in the school setting. To address this gap in implicit bias intervention research and the lack of equity-focused implementation strategies, the investigators are conducting a pilot Hybrid Type 3 Effectiveness-Implementation Trial of a Virtual Implicit Bias Reduction and Neutralization Training (VIBRANT)-a highly efficient (\~45 minutes), usable, and scalable intervention (interactive online training module) to address implicit bias among school mental health clinicians and support the equitable implementation of EBPs.

With previous NIMH funding, VIBRANT was iteratively developed for school mental health clinicians employing user-centered design principles. In a small proof-of-concept study (N = 12), school mental health clinicians found VIBRANT to be highly usable, appropriate, acceptable, and feasible to implement in their clinical practice. After completing the VIBRANT training, clinicians demonstrated notable improvements in implicit bias knowledge, and a downward trend in implicit bias (as measured by the Implicit Association Test) over 14 weeks. Moreover, clinicians with the greatest reductions in implicit bias also reported the strongest alliance with their youth patients. These results from our preliminary studies suggest that VIBRANT is an efficient and highly usable implementation strategy that holds promise for addressing clinician implicit bias to promote equitable implementation of other highly scalable evidence-based interventions.

Although VIBRANT is EBP-agnostic, it will be tested in the context of measurement-based care (MBC) implementation given (1) the high potential for MBC to optimize school mental health services, but currently inconsistent use in school mental health, and (2) MBC's vulnerability to inequitable delivery. Specifically, this study will evaluate the preliminary effectiveness of VIBRANT as an equity-focused implementation strategy for MBC. In addition to assessing VIBRANT's impact on equitable MBC adoption, penetration, fidelity, and sustainment within and between clinician caseloads, the investigators will also examine impact on proximal mechanisms of change (clinician implicit bias, therapeutic alliance) and distal youth clinical and functional outcomes.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for each of the subjects participating in the study as follows:

1. Participating clinicians must...

   1. Provide school-based mental health services in middle and high school settings for at least 50% of their clinical deployment.
   2. Provide on-going 1:1 mental health services to students (e.g., not assessment only).
   3. Have a caseload (who is receiving on-going care) that consists of at least 20% of Black or Latinx students.
2. Participating youths must...

   1. Identify as Black/African American or/and Hispanic/Latina/Latino/Latinx
   2. be entering into ongoing treatment with a participating clinician in the school mental health setting
3. 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

Exclusion Criteria:

Exclusion criteria for each of the subjects participating:

1. School-based mental health clinicians

   1. 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.
   2. Clinicians who have participated in a previous study related to VIBRANT.
2. Black \& Latinx youth

   1. 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.
   2. Youths who do not speak English or Spanish
3. Caregivers

   1. 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.
   2. Caregiver who do not speak English or Spanish

Primary outcomes:
measure: Adoption of Measurement-Based Care (MBC) strategies
timeFrame: 4-month (follow-up 2)
measure: Penetration or saturation of Measurement-Based Care (MBC) strategies use
timeFrame: 4-month (follow-up 2)
measure: Sustainment of Measurement-Based Care (MBC) strategies use
timeFrame: 4-month (follow-up 2)
measure: Fidelity of Measurement-Based Care (MBC) Strategies use
timeFrame: 4-month (follow-up 2)
measure: Change in Clinician's Implicit Association Test (IAT) Scores
timeFrame: 0-months (Pre-training), 1-month (post-training), 2-month follow-up 1, and 4-month (follow-up 2)
measure: Change in Clinician and Youth Working Alliance Inventory--Short Form scores
timeFrame: 1-month (post-training), 4-month (follow-up 2)
measure: Change in Strengths and Difficulties Questionnaire (SDQ) youth and caregiver report scores
timeFrame: 1-month (post-training), 4-month (follow-up 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Freda Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhatty GB. Subdural haematoma: an evaluation of treatment methods. J Indian Med Assoc. 1996 Jan;94(1):7-10.
citation: 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.
citation: 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.