Disruptive Behavior DisorderNCT04113161
Navigating Resource-Constrained Systems and Communities to Promote the Behavioral Health of Black Youth
A study testing Child Behavioral Health Navigator (cbhN) in people with Disruptive Behavior Disorder, run by Washington University School of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disruptive Behavior Disorder
- What is being tested?
- Child Behavioral Health Navigator (cbhN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brown School at Washington University in St. Louis
St Louis, Missouri, 63130
Mary M McKay, PhD, 314-935-6693, mary.mckay@wustl.edu
Sean Joe, PhD, 314-935-6145, sjoe@wustl.edu
About this study
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.
Read the 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.
- Conditions
- Disruptive Behavior Disorder
- Being tested
- Standard Care, Child Behavioral Health Navigator (cbhN)
- Keywords
- Peer Navigators, Disruptive Behavior Disorder, Access Inequalities
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Child Behavioral Health Navigator (cbhN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Changes in perceptual obstacles from three to 12 months followup
Semi-structured interview
Perceived barriers and facilitators to screening, assessment, and care
Measured: Changes from baseline to three to 12 months followup
Secondary outcomes (4)
Implementation and Feasibility Checklists
Implementation of the intervention
Measured: Changes in implementation and perceived feasibility of delivery from baseline to three to 12 months followup
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.
Measured: Changes from three to 12 months followup
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.
Measured: Changes from three to 12 month followup
Project Reach Care and System Tracking Tools
System collaboration
Measured: Changes from three to 12 months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Jan 2020
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Youth and their families will receive 1) standard care or 2) the cbhN intervention.
- Masking
- None (open label)
- Enrolment
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary McKay, Washington University School of Medicine
- Investigators
- Mary M McKay, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113161
- Sponsor's protocol ID
- MH116895
- Status last verified
- Apr 2023
- First submitted
- 26 Sep 2019
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigating Resource-Constrained Systems and Communities to Promote the Behavioral Health of Black Youth
- ClinicalTrials.gov ID
- NCT04113161
- Acronym / sponsor ID
- MH116895
- Conditions
- Disruptive Behavior Disorder
- Keywords
- Peer Navigators, Disruptive Behavior Disorder, Access Inequalities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Youth and their families will receive 1) standard care or 2) the cbhN intervention.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard CareStandard 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. |
| Child Behavioral Health Navigators (cbhN) | Experimental | Other: Child Behavioral Health Navigator (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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CareStandard 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. | Other | Standard Care |
| 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. | Other | Child Behavioral Health Navigators (cbhN) |
Primary outcome
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 (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)
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 (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
Time frame: Change in conduct symptoms from three months to 12 months followup
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)
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).
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.
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.
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.
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.
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.
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).
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.
Semi-structured interview
Time frame: Changes from baseline to three to 12 months followup
Perceived barriers and facilitators to screening, assessment, and care
4 secondary outcomes
Implementation and Feasibility Checklists
Time frame: Changes in implementation and perceived feasibility of delivery from baseline to three to 12 months followup
Texas Christian University (TCU) Survey of Organizational Functioning
Time frame: Changes from three to 12 months followup
Program Sustainability Assessment Tool (PSAT)
Time frame: Changes from three to 12 month followup
Project Reach Care and System Tracking Tools
Time frame: Changes from three to 12 months followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary M McKay, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child Behavioral Health Navigator (cbhN) in people with Disruptive Behavior Disorder, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mary M McKay, PhD (314-935-6693, mary.mckay@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disruptive Behavior Disorder Rating Scale (DBDRS) (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.