Clinical trial NCT05294042: Patient Navigators for Children's Community Mental Health Services in High Poverty Urban Communities
Official title: Patient Navigators for Children's Community Mental Health Services in High Poverty Urban Communities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Community Mental Health Services
Keywords: Child Mental Health Services
Racial and Ethnic Disparities
Urban Poverty
Navigation
Paraprofessional
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 154
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose is to study a model of mental health navigation for African American and Latinx children (0-14 years) in high poverty urban communities focused on reducing key parental attitudinal barriers to care. Reducing persistent racial and ethnic disparities in children's mental health is a national priority and patient navigation is a highly promising approach that is rarely used in children's mental health services. The study will examine the effectiveness of paraprofessional (PP) navigators who have strong community knowledge and waitlist as usual condition (active wailt list \[AWL\]. The study will examine specific mechanisms of navigator effectiveness in children's mental health and compare an AWL to provide a rigorous test of the proposed mechanisms. The knowledge gained from this application may be important to reducing disparities and employing the workforce best suited to navigation in the community mental health system. Two community boards, one focused on identifying factors important to supporting navigators at the agencies (Implementation and Sustainability Community Board) will meet quarterly, and the other focused on implications for state and federal policy (Public Policy Board), will meet annually.

Detailed description: Navigation to promote entry into health services, originally developed to address racia disparities in cancer screening and treatment, is only recently gaining prominence in mental health. Recent reviews recommend navigation for many health-related services including mental health services for transition-age youth and for children with medical complexity and comorbid mental health disorders. Logistical barriers are common across the health care system. However, for mental health services, stigma is also a prominent barrier. Paraprofessionals (PPs) have been key in efforts to reduce disparities in access to social services both nationally and internationally, presumably because their similarities to families can facilitate families' access to and retention in mental health services given their ability to relate to families' struggles. In this study, the investigators will examine paraprofessionals' (PP's) effectiveness as navigators for children's behavioral health services as compared to an active waitlist (AWL). For this study, AWL involves periodic check-ins by community agency intake staff with waitlist families to inquire about continued interest in services and provide resources as needed. For navigation, key elements of engagement and family support will be provided through in-person and virtual trainings including role play and feedback.

Specific aims are to examine:

1. Initial entry into appropriate behavioral health services. Hypothesis: Caregivers assigned to a PP navigator will be more likely to initiate services for their child as compared to families on AWL, as mediated by reduced stigma and more positive attitudes towards behavioral health services.
2. Ongoing engagement in services Hypothesis: Caregivers assigned a PP navigator will be more likely to retain their child in more sessions of ongoing care as compared to families on the AWL, as mediated by PP's ability to act as a boundary spanner.
3. Child and caregiver outcomes at baseline, 6, 12, and 18 months post intake. Hypothesis: Children and caregivers in the PP navigator condition will evidence stronger outcomes as compared to families in AWL, as mediated by PP's integration into caregiver's social support network.
4. Key stakeholder perspectives. Navigator and caregiver experiences with navigation, and caregiver experiences with AWL, will be examined through semi-structured qualitative interviews to identify perceived barriers and facilitators to service engagement.

The investigators will examine these hypotheses using an explanatory sequential mixed method design. Multi-level and longitudinal quantitative data will include information on (1) initial and ongoing use of services assessed via agency electronic medical record (EMR) data; (2) the type and rate of navigator services to families as assessed via EMR data and parent report of navigator endorsement of recommended services; (3) caregiver attitudes and services received, assessed through caregiver report; (4) integration of navigator into caregiver social support network assessed via caregiver report of a social support network; and (5) child and caregiver outcomes as assessed by the caregiver and therapist report collected during 6-month intervals up to 18 months post intake (baseline).

Quantitative data will be analyzed by generalized estimating equations models (GEE) accounting for the clustering effect of agencies and navigators and adjusted for covariates.

Qualitative analysis of independent interviews with PPs and caregivers will be conducted to contextualize and clarify the quantitative findings.

Two community boards will provide an opportunity for inter-agency communication and support by sharing challenges and successes and providing insights into local and national policy. An Implementation and Sustainability Community Board will meet quarterly to address issues of fit within each organization and consistency with local system procedures, and a Public Policy Board will meet annually to consider how the research can inform local and national mental health policy

Eligibility criteria: Inclusion Criteria:

* African American and Latinx Children between 0 and 14 years of age and their caregiver
* New referrals on the waitlist for outpatient mental health services; families interested and engaged in social services from two state supported projects.
* Have been screened and deemed appropriate for services at one of two social service participating community mental health agencies; or engaged in services via navigation projects

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Initiation of services by caregiver
timeFrame: Up to 18 months
measure: Attendance in services; navigator and caregiver report
timeFrame: 18 months
measure: Change from Baseline Measure of Perceived Homophily at 6, 12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change from Baseline Social Network Assessment of Boundary Spanning at 6, 12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change from Baseline Norbeck Social Support at 6, 12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change from Baseline Parental Attitudes Toward Psychological Services at 6, 12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change from Baseline Family Empowerment at 6, 12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change from Baseline Vanderbilt Mental Health Self Efficacy at 6, 12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change from Baseline Barriers to Treatment Participation at 6,12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change from Baseline PROMIS Global Health Scale at 6, 12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change from Baseline OHIO Scales at 6, 12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change from Baseline Strength and Difficulties at 6, 12, and 18 months
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Demographics
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Tara Mehta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bieling PJ, Madsen V, Zipursky RB. A 'navigator' model in emerging mental illness? Early Interv Psychiatry. 2013 Nov;7(4):451-7. doi: 10.1111/eip.12078. Epub 2013 Jul 24.
citation: Glassgow AE, Martin MA, Caskey R, Bansa M, Gerges M, Johnson M, Marko M, Perry-Bell K, Risser HJ, Smith PJ, Van Voorhees B. An innovative health-care delivery model for children with medical complexity. J Child Health Care. 2017 Sep;21(3):263-272. doi: 10.1177/1367493517712063. Epub 2017 Jun 5.
citation: Mehta TG, Lakind D, Rusch D, Walden AL, Cua G, Atkins MS. Collaboration with Urban Community Stakeholders: Refining Paraprofessional-led Services to Promote Positive Parenting. Am J Community Psychol. 2019 Jun;63(3-4):444-458. doi: 10.1002/ajcp.12316. Epub 2019 Mar 1.
citation: Barnett ML, Gonzalez A, Miranda J, Chavira DA, Lau AS. Mobilizing Community Health Workers to Address Mental Health Disparities for Underserved Populations: A Systematic Review. Adm Policy Ment Health. 2018 Mar;45(2):195-211. doi: 10.1007/s10488-017-0815-0.
citation: Ahmed SM, Lemkau JP, Nealeigh N, Mann B. Barriers to healthcare access in a non-elderly urban poor American population. Health Soc Care Community. 2001 Nov;9(6):445-53. doi: 10.1046/j.1365-2524.2001.00318.x.