Mental Health Navigation Support for Early Childhood Mental Health Concerns

(MH Nav Trial)

Not currently recruiting at 1 trial location

Overseen By Robert Penfold, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Must not be taking: Mental health medications

Disqualifiers: Past mental health diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mental health navigator can help families obtain quicker and more personalized support for children showing early signs of mental health issues. Children who have not yet received mental health treatment and exhibit symptoms like mood changes or behavioral issues might be suitable candidates. Researchers will randomly assign participants to one of two groups: one will receive regular care (Control Arm), while the other will have a navigator providing phone support and up to four video therapy sessions over six months (Navigation Arm). As an unphased trial, this study offers families the chance to access innovative support strategies that could significantly enhance their child's mental health care experience.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking current medications. However, participants must be 'mental health treatment naïve,' meaning they should not have any previous mental health diagnoses or prescriptions. If you are currently on mental health medications, you may not be eligible for this trial.

Will I have to stop taking my current medications?

The trial is for children who have not previously been diagnosed with a mental health condition or taken mental health medications, so participants should not be on any current mental health medications. The protocol does not specify about other types of medications.

What prior data suggests that this mental health navigation support is safe for children?

Research shows that mental health navigator models are generally safe and well-received. These models employ mental health navigators to assist families in finding and using mental health care services. Studies have found that navigators can help families begin using these services early, which is crucial for managing symptoms effectively.

Studies have not reported major negative events related to mental health navigation. These programs aim to improve how families access mental health care without requiring intense medical treatments, which usually means fewer safety concerns. In general, phone and video support in mental health has been safely implemented in many situations, with participants reporting positive experiences and results.

The focus here is on providing guidance and support, not direct medical treatment. This approach reduces the risk of negative effects, making it a safe choice for families seeking help with early childhood mental health issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mental Health Navigation Support trial because it introduces a proactive, coordinated approach to early childhood mental health care. Unlike standard treatments, which typically rely on families and providers recognizing symptoms and seeking help independently, this trial uses a mental health navigator to actively monitor and engage families right from the onset of symptoms. This includes automated symptom detection, virtual assessments, and direct coordination with healthcare providers. The result is a more personalized and timely intervention that could bridge gaps in existing mental health care for young children, potentially improving access to and engagement with mental health services.

What evidence suggests that this trial's treatments could be effective for early childhood mental health concerns?

This trial compares two approaches for addressing early childhood mental health concerns. Studies have shown that helping families navigate mental health care enables children to receive support sooner. In the Navigation Arm of this trial, participants receive six months of telephonic support from a mental health navigator. This method uses technology to identify early signs of issues and connects families with mental health guides. These guides help organize care and work with families to ensure children receive tailored treatment. Research indicates that early assistance through these guides can lead to better involvement and outcomes in mental health services. Initial findings suggest that video sessions with guides benefit families who struggle to access traditional in-person services. This approach aims to make care more efficient and ensure children receive necessary support. Meanwhile, participants in the Control Arm undergo assessments and receive feedback but do not receive navigation support. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

"Mental Health treatment naïve" per KP electronic records, defined as:

No prior MH specialty visits.

No previous ICD-9 or ICD-10 diagnosis for any MH condition;

Exclusion Criteria

Documentation of mental health issues in the encounter note describes someone other than the child (e.g., a sibling or parent's issue)

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

Subject is flagged as "interpreter needed" in Epic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Assessment

Formal assessment to ascertain primary mental health diagnosis and any co-occurring disorders

1 week

1 visit (virtual)

Intervention

6-months of telephonic support from a mental health navigator to promote early access, engagement, coordination, and personalization of mental health treatment and services

6 months

Monthly follow-up calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Control Arm
• Navigation Arm

Trial Overview 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.

How Is the Trial Designed?

Group I: Navigation Arm Experimental Treatment 1 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 Arm Experimental Treatment 1 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.

Control Arm is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as TICE BCG for:

• Bladder cancer

Approved in United States as TheraCys BCG for:

• Bladder cancer

Approved in European Union as OncoTICE for:

• Bladder cancer

Approved in Canada as ImmuCyst for:

• Bladder cancer

Approved in Japan as BCG Vaccine for:

• Bladder cancer
• Tuberculosis

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Published Research Related to This Trial

Lamotrigine is an effective and well-tolerated treatment for various childhood epilepsies, with approval for pediatric use in over 70 countries based on robust clinical trial data.

The efficacy of lamotrigine has been supported not only by controlled clinical trials but also by additional clinical practice data, reinforcing its safety and effectiveness in managing different seizure types in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of lamotrigine in pediatric patients. Messenheimer, J.[2018]

Lamotrigine works by stabilizing neuronal membranes through voltage-sensitive sodium channels, which helps inhibit the release of excitatory neurotransmitters, making it effective for maintaining treatment in bipolar I disorder.

In a review of 12 placebo-controlled trials, lamotrigine showed a low incidence of serious rashes, such as Stevens-Johnson syndrome, with rates of 0.08% in adults using it as monotherapy for bipolar disorder, indicating it is generally safe and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of lamotrigine: results from 12 placebo-controlled clinical trials and clinical implications. Seo, HJ., Chiesa, A., Lee, SJ., et al.[2022]

Approximately 1.2 million children and youth in Canada face mental health and addiction issues, yet less than 20% receive appropriate treatment, highlighting a significant gap in care that navigation services aim to address.

The proposed research will synthesize evidence on youth mental health navigation to establish comprehensive standards for care, involving a collaborative team that includes researchers and individuals with lived experience, which may enhance the integration and continuity of care for affected youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigation for youth mental health and addictions: protocol for a realist review and synthesis of approaches and practices (The NavMAP standards project). Markoulakis, R., Arora, SRA., Kodeeswaran, S., et al.[2022]

Women are at a higher risk for perinatal mood and anxiety disorders (PMADs) during the perinatal period, and many do not receive the necessary mental health care despite the availability of effective treatments.

The development of a patient navigation (PN) service in an intensive outpatient program has shown promise in improving treatment attendance and engagement for women with PMADs, suggesting that this model could be beneficial for other care facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Stepped Care Model of Patient Navigation to Enhance Engagement with Perinatal Mental Health Care. DiSanza, CB., Geller, PA., Bonacquisti, A., et al.[2020]

Many children with mental health issues are not receiving the help they need, and pediatric primary care clinics could be key places to identify and address these problems early.

Family navigators, who help families navigate the mental health system, show promise in improving engagement in mental health services for children, although more research is needed to fully understand their effectiveness in pediatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Mental Health Engagement From Primary Care: The Potential Role of Family Navigation. Godoy, L., Hodgkinson, S., Robertson, HA., et al.[2020]

Nearly 50% of adolescents experience mental health disorders, but only about half seek treatment, highlighting the need for effective referral systems like the behavioral health (BH) navigation program implemented in a large health system.

Over a 4-year period, the BH navigation program facilitated 4,555 referrals from 290 primary care physicians, with 91% of physicians reporting that the navigation services improved their clinical care, although satisfaction ratings declined over time, indicating ongoing challenges in maintaining positive assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care provider utilization and satisfaction with a health system navigation program for adolescents with behavioral health needs. Yang, Y., Dillon, EC., Li, M., et al.[2020]

In a long-term study involving 267 patients with Lennox-Gastaut syndrome, adjunctive clobazam demonstrated sustained efficacy, with a median 85% decrease in drop seizures after one year and maintaining significant reductions over five years.

The safety profile of clobazam remained consistent over the five-year period, with no new safety concerns arising, indicating that it is a safe long-term treatment option for patients with this challenging form of epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stable dosages of clobazam for Lennox-Gastaut syndrome are associated with sustained drop-seizure and total-seizure improvements over 3 years. Conry, JA., Ng, YT., Kernitsky, L., et al.[2022]

Patient navigator programs can significantly improve access to clinical and social services for children and youth with developmental and mental health conditions, especially for those from disadvantaged backgrounds.

Implementing these programs with a strong evaluation framework is crucial for enhancing health outcomes and ensuring equitable resource distribution in healthcare, particularly as services become more complex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigators: Mapping the route toward accessibility in health care. Rollins, M., Milone, F., Suleman, S., et al.[2020]

Major depressive disorder and other mood disorders are significantly more prevalent in emergency and inpatient settings, accounting for nearly 50% of diagnoses, indicating a potential gap in effective outpatient care for these conditions.

Only 1% of ambulatory care encounters included care navigation, despite 86% of care navigation encounters being related to mental health, suggesting a need for improved care coordination and resources in outpatient settings to better manage pediatric mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the pediatric mental health care continuum at an American health system. Thariath, J., Salhi, RA., Kamdar, N., et al.[2023]

This study is testing a new foster care family navigator (FCFN) model aimed at improving mental health service access and engagement for youth in the child welfare system, with 80 caregiver-youth dyads participating in a randomized controlled trial.

The FCFN model combines in-person navigation with digital health technology to enhance care coordination, and it is hypothesized that this approach will lead to higher rates of mental health treatment initiation and engagement compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial. Tolou-Shams, M., Ramaiya, M., Lara Salas, J., et al.[2023]

In a study of 16 patients with Lennox-Gastaut syndrome, 53% experienced more than a 50% reduction in seizure frequency when treated with adjunctive lamotrigine therapy, indicating its efficacy in managing various seizure types.

The treatment was generally well tolerated, with the most common side effects being infections and sleep disturbances, and no significant adverse effects on neurological function or lab tests were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lamotrigine adjunctive therapy in childhood epileptic encephalopathy (the Lennox Gastaut syndrome). Donaldson, JA., Glauser, TA., Olberding, LS.[2019]

In a study of 62 children with Lennox-Gastaut syndrome treated with zonisamide for at least 12 months, 27.4% experienced significant reductions in seizure frequency (more than 50% reduction), indicating its efficacy as an adjunctive therapy.

Zonisamide was found to be safe, with only transient side effects like somnolence and anorexia, which were manageable with proper follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical efficacy of zonisamide in Lennox-Gastaut syndrome: Korean multicentric experience. You, SJ., Kang, HC., Kim, HD., et al.[2018]

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