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Mental Health Navigation Support for Early Childhood Mental Health Concerns (MH Nav Trial)

N/A

Recruiting

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients 4 to 11 years, 150 days of age paneled to PC providers at KPNC clinics in the East Bay sub-region.

Patients 4 to 12 years, 150 days of age paneled to PC providers at KPWA clinics in the Seattle area;

Must not have

Past ICD-10 diagnosis for a mental health condition associated with any encounter type or prescription order, internal or external to the system);

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months from randomization date

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the effectiveness of offering 6-months of telephonic support from a mental health (MH) navigator to help early access, engagement, coordination, and personalization of mental health treatment and services for children who are at risk for behavioral health concerns.

Who is the study for?

This trial is for children aged 4 to just under the mental health emancipation age (12-13 depending on state), who show early signs of behavioral health concerns but have not yet been diagnosed or treated for any mental health conditions. They must be insured by Kaiser Permanente and have had no prior specialized mental health visits.

What is being tested?

The study tests a support system where at-risk children receive telephonic help from a mental health navigator over six months, aiming to improve access and coordination of care. It involves automated symptom identification, assessments by psychologists, and possible videoconferencing therapy sessions.

What are the potential side effects?

Since this trial focuses on navigation and support rather than medication or invasive procedures, traditional side effects are not expected. However, there may be emotional or psychological impacts from discussing mental health which will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 4 to 11 years old and see a doctor in the KPNC East Bay area.

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I am between 4 to 12 years old and see a primary care doctor at a KPWA clinic in Seattle.

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I have a mental health condition diagnosis but haven't started any treatment.

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I have never been prescribed mental health medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a mental health condition in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months from randomization date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months from randomization date

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months from randomization date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of youth initiating psychotherapy

Secondary study objectives

Percentage of youth attending at least 4 psychotherapy sessions

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Navigation ArmExperimental Treatment1 Intervention

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.

Group II: Control ArmExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control Arm

2020

Completed Phase 2

~3300

0 / 5Eligibility criteria met