Navigating Resource-Constrained Systems and Communities to Promote the Behavioral Health of Black Youth

Disruptive Behavior Disorder Clinical Trial

Official title:

Navigating Resource-Constrained Systems and Communities to Promote the Behavioral Health of Black Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113161
• Other study ID #: MH116895
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2023
• Source: Washington University School of Medicine
• Contact: Mary M McKay, PhD
• Phone: 314-935-6693
• Email: mary.mckay[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Disruptive Behavior Disorder
• Mental Disorders
• Problem Behavior

Intervention

Other:
• Standard Care
Standard care will consist of 1) community-based screening and referral conducted by HomeGrown St. Louis (HomeGrown StL) network members and supported by HomeGrown StL coordinator; and 2) monthly contacts by a case manager, who will track attendance in mental health services and provide referrals upon request.
• Child Behavioral Health Navigator (cbhN)
CbhNs will engage in a series of contacts in person and by phone/text to coordinate needed appointments at mental health care sites, as well as a range of human service support organizations (e.g. housing, food, financial, legal assistance). Over time, contact may decrease as the youth/family make ongoing connection with mental health care and other resources. However, over the course of the study (twelve months), twice per month check-ins will be routine between cbhNs and families. In addition, the cbhN will be expected to actively engage with the range of service providers and mental health resources as needed and preferred by the family. These contacts include telephone linkage calls, in-person advocacy meetings and at time, accompanying the youth and families to meetings at each organization.

Locations

Country	Name	City	State
United States	Brown School at Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disruptive Behavior Disorder Rating Scale (DBDRS)	Screening for DBDs. The DBDRS consists of 45 items that are ranked using a four-point Likert scale ranging from "not at all" (0) to "very much" (3). There are three subscales: conduct disorder (CD), oppositional defiant disorder (ODD), and attention deficit hyperactivity disorder (ADHD; inattention type, impulsive type, or combined). The CD subscale consists of 15 items (range 0-45), and 3 or more items must be endorsed as "pretty much" or "very much" to meet criteria. The ODD subscale consists of 6 items (range 0-24), and 4 or more items must be endorsed as "pretty much" or "very much" to meet criteria. Both the ADHD, inattention type and hyperactive impulsive type subscales consist of 9 items (range 0-27), and 6 or more items must be endorsed as "pretty much" or "very much" to meet criteria. If 6 or more items are endorsed across both subscales, than criteria is met for ADHD, combined type.	Baseline
Primary	Disruptive Behavior Disorder Rating Scale (DBDRS)	Symptoms of DBDs. The DBDRS consists of 45 items that are ranked using a four-point Likert scale ranging from "not at all" (0) to "very much" (3). There are three subscales: conduct disorder (CD), oppositional defiant disorder (ODD), and attention deficit hyperactivity disorder (ADHD; inattention type, impulsive type, or combined). The CD subscale consists of 15 items (range 0-45), and 3 or more items must be endorsed as "pretty much" or "very much" to meet criteria. The OD subscale consists of 6 items (range 0-24), and 4 or more items must be endorsed as "pretty much" or "very much" to meet criteria. Both the ADHD, inattention type and hyperactive impulsive type subscales consist of 9 items (range 0-27), and 6 or more items must be endorsed as "pretty much" or "very much" to meet criteria. If 6 or more items are endorsed across both subscales, than criteria is met for ADHD, combined type.	Change in Disruptive Behavior Disorders symptoms from three months to 12 months followup
Primary	IOWA Connors Rating Scale	Symptoms of oppositional defiant behavior. the IOWA (IOWA) Connors Rating Scale is a brief measure of inattention-overactive and oppositional-defiant behavior in children. It consists of 10 items, and responses range from "not at all" (0) to "very much" (3). There are two subscales: inattention-overactive (IO) and oppositional-defiant (OD). Five items constitute each subscale, and a score of 10 or higher is considered the clinical cutoff for meeting criteria for the IO subscale, and 9 or higher is the clinical cutoff for the OD subscale (as rated by caregivers).	Change in conduct symptoms from three months to 12 months followup
Primary	Strengths and Difficulties Questionnaire (SDQ)	The SDQ is a brief behavioral screening questionnaire consisting of 25 attributes divided across five subscales: 1) emotional symptoms, 2) conduct problems, 3) hyperactivity/inattention, 4) peer relationship problems, and 5) prosocial behaviors. Each item is ranked along a three-point Likert scale ranging from "not true" (0) to "certainly true" (2), and each subscale ranges from 0-10, with higher scores are indicating greater difficulties in each subscale, with the exception of the subscale prosocial behaviors. The total score ranges from 0-40 and is generated from the four subscales (excluding the prosocial behaviors subscale).	Change in behavior symptoms from three months to 12 months followup
Primary	Impairment Rating Scale (IRS)	The IRS consists of six items that asks caregivers to rate the severity of their child's impairment across functional domains including their relationship with peers, parents, and siblings; academic progress; and family functioning. Respondents place an X on a 7-point scale to signify their child's functioning along a continuum of impairment that ranges from 0 (no need for treatment) to 6 (extreme need for treatment). Scores of three or greater per item indicate clinical impairment.	Change in functional impairment from three months to 12 months followup
Primary	Project Reach Care and System Tracking Tools	The Project Reach Care and System Tracking Tools assess child mental health service use by type and attendance. Number of appointments attended can be computed via the sum of all appointments kept versus scheduled.	Through study completion, an average of one year
Primary	Electronic Medical Record Abstractions	Electronic medical record abstractions will measure child mental health service use by attendance. Number of appointments attended can be computed via the sum of all appointments kept versus scheduled.	Through study completion, an average of one year
Primary	Service Implementation Checklist	The Service Implementation Checklist will track child mental health service use by type and attendance. Number of appointments attended can be computed via the sum of all appointments kept versus scheduled.	Through study completion, an average of one year
Primary	Working Alliance Inventory-Short Form (WAI)	The WAI-Short Form consists of 12 items that measures a client's alliance with their treatment provider, including agreement on goals and tasks, and the bond between client and provider. Each item is ranked using a 7-point Likert scale ranging from "never" (1) to "always" (7). Items are summed for a total score of between 12 and 84, and higher scores indicate a stronger working alliance.	Change in working alliance with child mental health providers from three months to 12 months followup
Primary	Metropolitan Area Child Study (MACS) Process Records	Facilitators and barriers to services is measured by the MACS, which consists of 76 items ranked along a 4-point Likert scale ranging from "strongly disagree" (1) to "strongly agree" (4). There are 8 subscales: 1) treatment satisfaction (14 items, range from 14-56, higher scores indicate greater satisfaction); 2) relationship with their therapist (13 items, range from 13-52, higher scores indicate a more positive relationship; 3) positive change (5 items, range from 5-20, higher scores indicate greater change; 4) treatment dynamics (11 items, range 11-44, higher scores mean higher positive dynamics; 5) cooperation (6 items, range 6-24, higher scores indicate greater cooperation); 6) prosocial behavior (3 items, range 3-12, higher scores indicate greater prosocial behavior, 7) aggression (8 items, range 8-32, higher scores indicate greater aggression); 8) parenting practices (6 items, range 6-24, higher scores indicate greater effort and ability related to parenting).	Change in factors that facilitate or impede child mental health service delivery three months to 12 months followup
Primary	Beliefs about Mental Illness (BMI) Scale	The BMI is a measure of negative stereotypical views of mental illness, including that it is incurable and shameful, and that people with mental health difficulties are dangerous and untrustworthy. Composed of 24 items, respondents rate their level of agreement with each item. Items are ranked on a six-point Likert scale ranging from completely disagree (0) to completely agree (5). Total scores range from 0-120, with higher scores indicating more negative beliefs about mental illness.	Changes in perceptual obstacles from three to 12 months followup
Primary	Semi-structured interview	Perceived barriers and facilitators to screening, assessment, and care	Changes from baseline to three to 12 months followup
Secondary	Implementation and Feasibility Checklists	Implementation of the intervention	Changes in implementation and perceived feasibility of delivery from baseline to three to 12 months followup
Secondary	Texas Christian University (TCU) Survey of Organizational Functioning	The TCU measures organizational functioning and barriers to implementation in areas such as program and training needs, pressures for change, program resources and organizational dynamics. The TCU consists of 129 items and 18 scales. For this study, 11 subscales will be used: 1) program needs, 2) training needs, 3) pressures for change, 4) training, 5) growth, 6) efficacy, 7) adaptability, 8) cohesion, 9) communication, 10) stress, and 11) change. All items are ranked on a five-point Likert scale representing the extent to which a provider agrees with each statement, with a range from "strongly disagree" (1) to "strongly agree" (5). Subscale scores range from 10 to 50, with higher scores indicating greater organizational readiness for change in that specific subscale.	Changes from three to 12 months followup
Secondary	Program Sustainability Assessment Tool (PSAT)	Sustainability of the cbhN intervention will be assessed via the PSAT, which consists of 40 items ranked along a seven-point Likert scale ranging from "too littler or to no extent" (1) to "to a very great extent" (7). There are eight subscales: 1) political support, 2) funding stability, 3) partnerships, 4) organizational capacity, 5) program evaluation, 6) program adaptation, 7) communications, 8) strategic planning. All subscales consist of five items, and the range of scores is from 5-35, with greater scores indicating greater likelihood of sustainability.	Changes from three to 12 month followup
Secondary	Project Reach Care and System Tracking Tools	System collaboration	Changes from three to 12 months followup