Assisted Identification and Navigation of Early Mental Health Symptoms in Children

NCT05064293 | Completed DMC

• 1 other identifier: 1726723
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

mental health navigation; adolescent mental health

Outcome Measures

Primary Outcomes (1)

• Percentage of youth initiating psychotherapy

  Youth initiating psychotherapy divided by all youth enrolled in the study arm

  6 months from randomization date

Secondary Outcomes (1)

• Percentage of youth attending at least 4 psychotherapy sessions

  6 months from randomization date

Study Arms (2)

Control Arm

OTHER

Data will be collected at baseline and 6-month follow-up from the standardized instruments and automated sources for all eligible subjects randomized to the 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. 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. Study clinicians will document clinically relevant information from their assessment in a telephone encounter and route these to the child's KP primary care provider in Epic as well as the site navigator. Control arm participants do not receive navigation.

Behavioral: Control Arm

Navigation Arm

EXPERIMENTAL

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 as soon as early symptoms of mental health problems are detected in children. The navigator model and implementation to be tested include: * Automated identification of early symptoms for children * Virtual collection of self-reported, standardized assessment scores * Psychologists interpreting assessment scores and providing feedback to families and PCPs * Trained clinicians serving as MH "navigators" to conduct family outreach, engage them in MH care, and coordinate with and between clinicians for up to 6-months * Up to 4 video-based behavioral health sessions with the MH navigator, as needed, while barriers to initiation of ongoing mental health services can be explored and addressed over the 6-month period.

Behavioral: Navigation Arm

Interventions

Navigation Arm BEHAVIORAL

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.

Navigation Arm

Control Arm BEHAVIORAL

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.

Control Arm

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Inclusions * Patient is ≥ 4 and less than 7 months from the mental health emancipation age in the respective State on the date of randomization. That age is 13 years of age in WA and 12 years of age in CA. Therefore, we will include these subjects: 1. Participants 4 to 12 years, 150 days of age paneled to PC providers at KPWA clinics in the Seattle area; 2. Participants 4 to 11 years, 150 days of age paneled to PC providers at KPNC clinics in the East Bay sub-region. * Treated in the internal delivery system and enrolled in a Kaiser Permanente insurance plan for at least 3 months prior to the PC note or MH diagnosis (index event); * "Mental Health treatment naïve" per KP electronic records, defined as: 1. No previous ICD-9 or ICD-10 diagnosis for any MH condition; 2. No previous orders for MH prescription medication(s) 3. \>1 prior MH specialty visits.. * AND at least one of the following at the index encounter per KP records: 1. ICD-10 diagnosis code for a mental health condition (and no psychotherapy or pharmacotherapy ordered or initiated to treat the diagnosed condition as of the randomization date); 2. Documentation of mental health symptoms or complaints in the free text of a progress note or secure message in primary care or pediatrics (with no diagnosis made, and with no pharmacotherapy). Exclusions * Past ICD-10 diagnosis for a mental health condition associated with any encounter type or prescription order, internal or external to the system); * Past mental health prescription medication ordered (including patient reported medication use, inpatient administration, past order for proposed off-label purpose, etc.); * Documentation of mental health issues in the encounter note describes someone other than the child (e.g., a sibling or parent's issue) * Note is from specialty, emergency or urgent care (i.e., not primary care or pediatrics). * Subject is flagged as "interpreter needed" in Epic. o Subject having a sibling from the same index encounter for mental health complaint * Describe how individuals will be screened for eligibility. We will identify potential participants automatically using diagnostic information and Natural Language Processing (NLP) of signed clinical notes from electronic health records (EHRs). All potentially eligible subjects will be automatically added to an Epic reporting workbench (patient list) once per week. Study staff will confirm the eligibility of each listed patient via chart review. All participants confirmed eligible will be randomly assigned to a study arm (intervention, usual care control). Outcomes data will be collected using the standardized instruments and from the electronic records of all randomized participants for study analysis. The MH navigator will review the medical record for each patient automatically identified for the study. This review will occur prior to any arm assignment. Those found to have exclusions will be marked ineligible. Participants deemed eligible will then be randomly assigned to one of two study arms. Eligibility review will occur no later than 10 days following the index event.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (2)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Kaiser Permanente Washington

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-group, randomized and pragmatic trial

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: September 7, 2021
• Primary Completion: August 1, 2025
• Study Completion: November 30, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (2)