Clinical trial NCT04113161: Navigating Resource-Constrained Systems and Communities to Promote the Behavioral Health of Black Youth
Official title: Navigating Resource-Constrained Systems and Communities to Promote the Behavioral Health of Black Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disruptive Behavior Disorder
Keywords: Peer Navigators
Disruptive Behavior Disorder
Access Inequalities
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 405
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Youth and their families will receive 1) standard care or 2) the cbhN intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to reduce racial disparities in child mental health care by examining the impact of a child behavioral health navigator (cbhNs) intervention in which cbhNs (n=15) will be trained to deliver an evidence-based family engagement, psychoeducation and support intervention to 390 early adolescent youth (10 to 14 years) and their families of African descent living in geographically defined St. Louis north city and county neighborhoods.

Detailed description: Black youth living in poverty-impacted communities are disproportionately burdened by behavioral health challenges, notably serious disruptive behavioral difficulties (DBDs). In some urban communities, prevalence rates of conduct related difficulties among young people of color exceed 40%. Simultaneously, serious care disparities are widespread and persistent. Without access to care, children with DBDs frequently suffer impairment in school functioning, strained relationships with teachers, peers and family members, and coercive interactions with school discipline or juvenile justice authorities. The seemingly intractable challenges of identifying, engaging and retaining low-income children of color and their families in needed mental health care has persisted despite significant scientific advances, including: a) decades of research identifying the multi-level barriers to care experienced by families of color; b) multiple investigations supporting a range of provider training approaches capable of enhancing family engagement; and c) empirical support for integrating outreach specialists, case managers and parent peer support staff across health, mental health, school and community-based settings to address behavioral health care gaps.

This study is based on the premise that if care navigation models are going to succeed where previous efforts have failed in eliminating racial disparities in child mental health care, then the preparation and support for child behavioral health navigators (cbhNs) needs to include: 1) training to deliver evidence-based family engagement, psychoeducation and support interventions; 2) ongoing coaching and supervision focused on building collaborative relationships between families and providers and; 3) skills to enhance community/system buy-in, as well as to analyze and interrupt multi-level structural influences on disparities and system gaps (including training to assess and intervene in the complex relationships between youth, adult caregivers, providers, system leaders, and community-based networks) within low-income communities.

The proposed study will be conducted in 2 phases. Phase 1 involves the recruitment and training of a new cohort of cbhNs (n=15), intentionally involving committed individuals of color from an existing community-based network of youth service system partners, HomeGrown STL. CbhNs (n=15) will be hired based on experience serving youth and families in target communities, St. Louis north city and county neighborhoods, but do not necessarily have extensive mental health training. CbhNs will be prepared to collaborate with youth/families via an interactive training protocol which integrates existing evidence-based cbhN approaches, including engagement interventions, family support and education, adapted care navigation models and empirically supported implementation strategies to address barriers.

Phase 2 is a mixed methods, hybrid effectiveness implementation experimental study, enrolling 390 early adolescent youth (10 to 14 years) of African descent and their families living in geographically defined St. Louis north city and county neighborhoods (racially segregated areas with high poverty concentration), aimed at simultaneously examining multi-level factors that enhance or impede cbhN interaction and youth/family outcomes. This study exclusively focuses on youth and families frequently missed or not retained in services.

The following specific aims guide the proposed study:

Primary Aim #1: To examine youth/family level outcomes associated with cbhNs (e.g. rates of identification of DBDs, youth/family engagement and motivation, access to assessment/care, alliance with and response to cbhNs, youth behavioral functioning over time); Primary Aim #2: To identify multi-level factors that impede/facilitate navigation (e.g. stigma, gaps in collaboration across youth, families, providers, system level limitations, relationship with cbhN); Exploratory Aim #1: To explore the response to cbhNs by key network and system stakeholders (e.g. perceptions of cbhN helpfulness, understanding and support for cbhN relationships with families, attributions of reductions in system barriers), as well as of the cbhNs, specifically their response to evidence-informed interactive training (e.g. child behavioral health and care knowledge and navigation skill, efficacy regarding collaboration with families, providers and systems).

This study is being conducted by a transdisciplinary network of scientists at Washington University in St. Louis (STL) and New York University in collaboration with service organizations, child behavioral health policy officials and the HomeGrown St. Louis (STL) network, including an existing Advisory Board. The proposed study is set within high poverty communities and focused on youth/families of color who rely on resource-constrained clinics to address serious youth mental health needs. The study capitalizes on significant preliminary work, including the mapping of all early adolescent youth of African descent in the target communities and the collaborative refinement of an evidence-informed cbhN training protocol. This application aligns with NIH's priorities to address underlying health disparities, as well as to enhance public health impact of mental health focused research studies.

Eligibility criteria: There are two samples in this study: 1) child/caregiver dyads (n=390) and 2) child behavioral health navigators (n=15). Inclusion and exclusion criteria are as follows:

1. Youth Caregiver Dyads: Inclusion Criteria: Youth of African descent, between 10 and 14 years, evidencing elevated behaviors associated with DBDs, and willing to provide assent and who has an adult caregiver capable of providing informed consent. Caregiver will have physical custody of the youth.

   Exclusion Criteria: Youth or adult caregivers not capable of providing informed consent, or evidencing an emergency psychiatric or safety issue that requires immediate attention to prevent harm to self or others.
2. CbhN: Inclusion Criteria: Adults \> 21 years, primarily of African descent who have experience working or volunteering in the target communities; willing to participate in the study and provide informed consent.

Exclusion Criteria: Adults not capable of providing informed consent, or evidencing an emergency psychiatric or safety issue that requires immediate attention to prevent harm to self or others.

Primary outcomes:
measure: Disruptive Behavior Disorder Rating Scale (DBDRS)
timeFrame: Baseline
measure: Disruptive Behavior Disorder Rating Scale (DBDRS)
timeFrame: Change in Disruptive Behavior Disorders symptoms from three months to 12 months followup
measure: IOWA Connors Rating Scale
timeFrame: Change in conduct symptoms from three months to 12 months followup
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Change in behavior symptoms from three months to 12 months followup
measure: Impairment Rating Scale (IRS)
timeFrame: Change in functional impairment from three months to 12 months followup
measure: Project Reach Care and System Tracking Tools
timeFrame: Through study completion, an average of one year
measure: Electronic Medical Record Abstractions
timeFrame: Through study completion, an average of one year
measure: Service Implementation Checklist
timeFrame: Through study completion, an average of one year
measure: Working Alliance Inventory-Short Form (WAI)
timeFrame: Change in working alliance with child mental health providers from three months to 12 months followup
measure: Metropolitan Area Child Study (MACS) Process Records
timeFrame: Change in factors that facilitate or impede child mental health service delivery three months to 12 months followup
measure: Beliefs about Mental Illness (BMI) Scale
timeFrame: Changes in perceptual obstacles from three to 12 months followup
measure: Semi-structured interview
timeFrame: Changes from baseline to three to 12 months followup
Secondary outcomes:
measure: Implementation and Feasibility Checklists
timeFrame: Changes in implementation and perceived feasibility of delivery from baseline to three to 12 months followup
measure: Texas Christian University (TCU) Survey of Organizational Functioning
timeFrame: Changes from three to 12 months followup
measure: Program Sustainability Assessment Tool (PSAT)
timeFrame: Changes from three to 12 month followup
measure: Project Reach Care and System Tracking Tools
timeFrame: Changes from three to 12 months followup
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Brown School at Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mary M McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References: