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

Primary Purpose

Disruptive Behavior Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Care
Child Behavioral Health Navigator (cbhN)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Disruptive Behavior Disorder focused on measuring Peer Navigators, Disruptive Behavior Disorder, Access Inequalities

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Brown School at Washington University in St. LouisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

Child Behavioral Health Navigators (cbhN)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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).
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).
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.
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.
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.
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.
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.
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).
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.
Semi-structured interview
Perceived barriers and facilitators to screening, assessment, and care

Secondary Outcome Measures

Implementation and Feasibility Checklists
Implementation of the intervention
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.
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.
Project Reach Care and System Tracking Tools
System collaboration

Full Information

First Posted
September 26, 2019
Last Updated
April 25, 2023
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04113161
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior Disorder
Keywords
Peer Navigators, Disruptive Behavior Disorder, Access Inequalities

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Youth and their families will receive 1) standard care or 2) the cbhN intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Child Behavioral Health Navigators (cbhN)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Child Behavioral Health Navigator (cbhN)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disruptive Behavior Disorder Rating Scale (DBDRS)
Description
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.
Time Frame
Baseline
Title
Disruptive Behavior Disorder Rating Scale (DBDRS)
Description
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.
Time Frame
Change in Disruptive Behavior Disorders symptoms from three months to 12 months followup
Title
IOWA Connors Rating Scale
Description
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).
Time Frame
Change in conduct symptoms from three months to 12 months followup
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
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).
Time Frame
Change in behavior symptoms from three months to 12 months followup
Title
Impairment Rating Scale (IRS)
Description
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.
Time Frame
Change in functional impairment from three months to 12 months followup
Title
Project Reach Care and System Tracking Tools
Description
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.
Time Frame
Through study completion, an average of one year
Title
Electronic Medical Record Abstractions
Description
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.
Time Frame
Through study completion, an average of one year
Title
Service Implementation Checklist
Description
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.
Time Frame
Through study completion, an average of one year
Title
Working Alliance Inventory-Short Form (WAI)
Description
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.
Time Frame
Change in working alliance with child mental health providers from three months to 12 months followup
Title
Metropolitan Area Child Study (MACS) Process Records
Description
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).
Time Frame
Change in factors that facilitate or impede child mental health service delivery three months to 12 months followup
Title
Beliefs about Mental Illness (BMI) Scale
Description
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.
Time Frame
Changes in perceptual obstacles from three to 12 months followup
Title
Semi-structured interview
Description
Perceived barriers and facilitators to screening, assessment, and care
Time Frame
Changes from baseline to three to 12 months followup
Secondary Outcome Measure Information:
Title
Implementation and Feasibility Checklists
Description
Implementation of the intervention
Time Frame
Changes in implementation and perceived feasibility of delivery from baseline to three to 12 months followup
Title
Texas Christian University (TCU) Survey of Organizational Functioning
Description
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.
Time Frame
Changes from three to 12 months followup
Title
Program Sustainability Assessment Tool (PSAT)
Description
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.
Time Frame
Changes from three to 12 month followup
Title
Project Reach Care and System Tracking Tools
Description
System collaboration
Time Frame
Changes from three to 12 months followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary M McKay, PhD
Phone
314-935-6693
Email
mary.mckay@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary C Acri, PhD
Phone
203-675-4691
Email
mary.acri@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary M McKay, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown School at Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary M McKay, PhD
Phone
314-935-6693
Email
mary.mckay@wustl.edu
First Name & Middle Initial & Last Name & Degree
Sean Joe, PhD
Phone
314-935-6145
Email
sjoe@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all outcome measures will be made available.
IPD Sharing Time Frame
Data will be made available within six months of study completion.
IPD Sharing 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.

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

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