Assisted Identification and Navigation of Early Mental Health Symptoms in Children
NCT05064293 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358
Last updated 2026-03-27
Summary
The randomized, two-arm pragmatic trial will test the effectiveness of offering 6-months of telephonic support from a mental health (MH) navigator to promote early access, engagement, coordination, and personalization of mental health treatment and services for children naïve to such treatments and services, and who are identified as being at risk for behavioral health concerns.
The model includes: (a) automated identification of early symptoms for children meeting criteria for behavioral health problems using a previously developed Natural Language Processing (NLP) program and predictive algorithm; (b) standardized instruments for assessment and diagnosis of mental health disorders (c) 30 minute assessment appointments with a study psychologist (d) creation of an Epic "reporting workbench" and Epic "smart form" to facilitate the outreach, monitoring and follow-up of families/children by the MH navigator; (e) use of MH Navigators (e.g., clinical social workers) to conduct family outreach, and coordination with and between clinicians; and (f) the offer of one to four clinic-to-home videoconferencing brief therapy sessions to bridge families/children unwilling or unable to access in-person MH services.
Conditions
- Adolescent Behavior
- Mental Health Issue
Interventions
- BEHAVIORAL
-
Navigation Arm
Families will be offered a formal assessment to ascertain the primary mental health diagnosis and any co-occurring mental health disorders. After completing the online parent/guardian self-assessment, parents/guardians will meet with a mental health clinician to review their answers, discuss diagnoses, and refer the family back to the navigator for connection to care or study-provided tele-video visits. Navigators will outreach families monthly during the 6-month study period. The navigator will inquire about the child's status and re-evaluate barriers to access. When barriers exist, the navigator will help in facilitating specialty treatment initiation and assess appropriateness of tele-video therapy sessions until ongoing MH services can be arranged. Families/patients reporting that index symptoms have resolved will be offered a 'watchful waiting' approach. Subjects accepting 'watchful waiting' will be outreached quarterly, but not beyond the end of the 6-month follow-up period.
- BEHAVIORAL
-
Control Arm
Families who agree to participate will first be offered a formal assessment in order to ascertain the primary mental health diagnosis and any co-occurring mental health disorders (e.g., substance use). After completing the online parent/guardian self-assessment, parents/guardians will meet for 30 minutes with a mental health clinician to review their answers, discuss diagnoses, and refer the family back to their primary care provider. Control arm participants do not receive navigation.
Sponsors & Collaborators
-
Kaiser Permanente
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-07
- Primary Completion
- 2025-08-01
- Completion
- 2025-11-30
Countries
- United States
Study Locations
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