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

NCT04113161 | Unknown DMC

• 1 other identifier: MH116895
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Disruptive Behavior Disorder

Keywords

Peer Navigators; Disruptive Behavior Disorder; Access Inequalities

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Semi-structured interview

  Perceived barriers and facilitators to screening, assessment, and care

  Changes from baseline to three to 12 months followup

Secondary Outcomes (4)

• Implementation and Feasibility Checklists

  Changes in implementation and perceived feasibility of delivery from baseline to three to 12 months followup

• Texas Christian University (TCU) Survey of Organizational Functioning

  Changes from three to 12 months followup

• Program Sustainability Assessment Tool (PSAT)

  Changes from three to 12 month followup

• Project Reach Care and System Tracking Tools

  Changes from three to 12 months followup

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

Standard care will consist of 1) community-based screening and referral and 2) monthly contacts by a case manager, who will track attendance in mental health services and provide referrals upon request.

Other: Standard Care

Child Behavioral Health Navigators (cbhN)

EXPERIMENTAL

CbhNs will engage in a series of face to face and phone contacts with families 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.

Other: Child Behavioral Health Navigator (cbhN)

Interventions

Standard Care OTHER

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.

Standard Care

Child Behavioral Health Navigator (cbhN) OTHER

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.

Child Behavioral Health Navigators (cbhN)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Brown School at Washington University in St. Louis

St Louis, Missouri, 63130, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mary M McKay, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary M McKay, PhD

CONTACT

314-935-6693; mary.mckay@wustl.edu

Mary C Acri, PhD

CONTACT

203-675-4691; mary.acri@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neidorff Family and Centene Corportation Dean of the Brown School

Model Details: Youth and their families will receive 1) standard care or 2) the cbhN intervention.

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 2, 2019
• Study Start: January 1, 2020
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available within six months of study completion.
• Access Criteria: Data access requests will be reviewed by the Principal Investigator and investigative team. Requestors will be required to sign a Data Access Agreement.

Locations

US (1)