Mental Health Navigation Support for Early Childhood Mental Health Concerns

(MH Nav Trial)

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

358 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Mental Health Navigation Support for Early Childhood Mental Health Concerns is an effective treatment?

The available research shows that Mental Health Navigation Support can improve engagement in mental health services for children and youth. For example, one study found that navigation services helped connect children and families to necessary mental health care, which is often difficult to access. Another study highlighted that navigation programs can bridge gaps in accessing social and clinical services, especially for those who are disadvantaged. Additionally, a health system navigation program for adolescents showed that 91% of primary care providers felt that navigation enhanced their clinical care, indicating its effectiveness in improving access to mental health services. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Mental Health Navigation Support for Early Childhood Mental Health Concerns?

Research shows that using navigators, who help families find and access mental health services, can improve engagement in mental health care for children and youth. This approach has been promising in increasing access to care and improving health outcomes, especially in settings where mental health services are hard to access. ^{1 2 3 4 5}

What safety data exists for the mental health navigation treatment?

The provided research does not contain safety data for the mental health navigation treatment or any of its alternative names. The studies focus on the safety and efficacy of lamotrigine, clobazam, and zonisamide for conditions like Lennox-Gastaut syndrome and bipolar disorder, which are unrelated to the mental health navigation treatment. ^{6 7 8 9 10}

Is the treatment 'Mental Health Navigation Support' a promising treatment for early childhood mental health concerns?

Yes, Mental Health Navigation Support is a promising treatment. It helps children and their families find and access the right mental health care, which is often hard to do. This support can improve engagement in mental health services, especially for those who might otherwise miss out on the help they need. By connecting families to the right resources and services, it can lead to better mental health outcomes for children. ^{1 2 3 11 12}

How does the Mental Health Navigation Support treatment differ from other treatments for early childhood mental health concerns?

The Mental Health Navigation Support treatment is unique because it involves navigators who help families and children access mental health services by overcoming barriers to care. Unlike traditional treatments that focus solely on therapy or medication, this approach emphasizes personalized support and care planning to improve engagement and accessibility in mental health services. ^{1 2 3 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Increasing Mental Health Engagement From Primary Care: The Potential Role of Family Navigation. [2020]

2. England 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). [2022]

3. England pubmed.ncbi.nlm.nih.gov

Patient navigators: Mapping the route toward accessibility in health care. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A Stepped Care Model of Patient Navigation to Enhance Engagement with Perinatal Mental Health Care. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Primary care provider utilization and satisfaction with a health system navigation program for adolescents with behavioral health needs. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Lamotrigine adjunctive therapy in childhood epileptic encephalopathy (the Lennox Gastaut syndrome). [2019]

8. United States 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. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical efficacy of zonisamide in Lennox-Gastaut syndrome: Korean multicentric experience. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Safety and tolerability of lamotrigine: results from 12 placebo-controlled clinical trials and clinical implications. [2022]

11. Canada 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. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Evaluating the pediatric mental health care continuum at an American health system. [2023]