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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113161
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Mary McKay, Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Disruptive Behavior Disorder Other: Standard Care Other: Child Behavioral Health Navigator (cbhN) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Youth and their families will receive 1) standard care or 2) the cbhN intervention.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Navigating Resource-Constrained Systems and Communities to Promote the Behavioral Health of Black Youth
Actual Study Start Date : November 25, 2019
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Arm Intervention/treatment
Active Comparator: Standard Care
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
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.

Experimental: Child Behavioral Health Navigators (cbhN)
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)
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 Measures :
  1. Disruptive Behavior Disorder Rating Scale (DBDRS) [ Time Frame: Baseline ]
    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 (OD), 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.

  2. Disruptive Behavior Disorder Rating Scale (DBDRS) [ Time Frame: Change in Disruptive Behavior Disorders symptoms from three months to 12 months followup ]
    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 (OD), 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.

  3. IOWA Connors Rating Scale [ Time Frame: Change in conduct symptoms from three months to 12 months followup ]
    Symptoms of oppositional defiant behavior. the 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).

  4. Strengths and Difficulties Questionnaire (SDQ) [ Time Frame: Change in behavior symptoms from three months to 12 months followup ]
    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).

  5. Impairment Rating Scale (IRS) [ Time Frame: Change in functional impairment from three months to 12 months followup ]
    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.

  6. Project Reach Care and System Tracking Tools [ Time Frame: Through study completion, an average of one year ]
    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.

  7. Electronic Medical Record Abstractions [ Time Frame: Through study completion, an average of one year ]
    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.

  8. Service Implementation Checklist [ Time Frame: Through study completion, an average of one year ]
    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.

  9. Working Alliance Inventory-Short Form (WAI) [ Time Frame: Change in working alliance with child mental health providers from three months to 12 months followup ]
    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.

  10. Metropolitan Area Child Study (MACS) Process Records [ Time Frame: Change in factors that facilitate or impede child mental health service delivery three months to 12 months followup ]
    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).

  11. Beliefs about Mental Illness (BMI) Scale [ Time Frame: Changes in perceptual obstacles from three to 12 months followup ]
    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.

  12. Semi-structured interview [ Time Frame: Changes from baseline to three to 12 months followup ]
    Perceived barriers and facilitators to screening, assessment, and care


Secondary Outcome Measures :
  1. Implementation and Feasibility Checklists [ Time Frame: Changes in implementation and perceived feasibility of delivery from baseline to three to 12 months followup ]
    Implementation of the intervention

  2. Texas Christian University (TCU) Survey of Organizational Functioning [ Time Frame: Changes from three to 12 months followup ]
    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.

  3. Program Sustainability Assessment Tool (PSAT) [ Time Frame: Changes from three to 12 month followup ]
    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.

  4. Project Reach Care and System Tracking Tools [ Time Frame: Changes from three to 12 months followup ]
    System collaboration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113161


Contacts
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Contact: Mary M McKay, PhD 314-935-6693 mary.mckay@wustl.edu
Contact: Mary C Acri, PhD 203-675-4691 mary.acri@wustl.edu

Locations
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United States, Missouri
Brown School at Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Mary M McKay, PhD    314-935-6693    mary.mckay@wustl.edu   
Contact: Sean Joe, PhD    314-935-6145    sjoe@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Mary M McKay, PhD Washington University School of Medicine

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Responsible Party: Mary McKay, Neidorff Family and Centene Corportation Dean of the Brown School, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04113161    
Other Study ID Numbers: MH116895
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary McKay, Washington University School of Medicine:
Peer Navigators
Disruptive Behavior Disorder
Access Inequalities
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Behavioral Symptoms
Neurodevelopmental Disorders