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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05064293 on ClinicalTrials.gov