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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;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months from randomization date

Awards & highlights

MH Nav Trial 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.Check my eligibility

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.See study design

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.

MH Nav Trial 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.

MH Nav Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of youth initiating psychotherapy

Secondary outcome measures

Percentage of youth attending at least 4 psychotherapy sessions

MH Nav 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,112,693 Total Patients Enrolled

1 Trials studying Mental Health Issue

36 Patients Enrolled for Mental Health Issue

Media Library

Control Arm Clinical Trial Eligibility Overview. Trial Name: NCT05064293 — N/A

Mental Health Issue Research Study Groups: Control Arm, Navigation Arm

Mental Health Issue Clinical Trial 2023: Control Arm Highlights & Side Effects. Trial Name: NCT05064293 — N/A

Control Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05064293 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any specific qualifications for participation in this trial?

"In order to be accepted into this clinical trial, potential participants must exhibit adolescent behaviors and fall within the age range of 4-12. A total of 400 individuals are being admitted for evaluation."

Answered by AI

Are participants of any age being accepted for this research?

"This clinical trial can only accept patients aged 4 to 12. In total, 71 trials are suitable for minors and 39 studies cater to elderly individuals over 65."

Answered by AI

How many people are participating in this research endeavor?

"Affirmative. Information from clinicaltrials.gov shows that recruitment for this trial is currently underway, with the initial posting on March 10th 2022 and a recent update of March 15th 2022. Altogether, 400 participants are required between two medical centres."

Answered by AI

Are any new participants being admitted to this clinical trial at present?

"This trial is still actively searching for participants. It was first announced on March 10th 2022 and has gone through an update in the past week, as of the 15th of March."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assisted Identification and Navigation of Early Mental Health Symptoms in Children

2021. "Assisted Identification and Navigation of Early Mental Health Symptoms in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05064293.