Mental Health Navigation Support for Early Childhood Mental Health Concerns
(MH Nav Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Kaiser Permanente
No Placebo Group
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.
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.
12345What 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.
678910Is 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.
1231112Eligibility 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;
+8 more
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.
+2 more
Participant Groups
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.
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.
Control Arm is already approved in United States, 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kaiser Permanente Northern CaliforniaOakland, CA
Kaiser Permanente WashingtonSeattle, WA
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Who Is Running the Clinical Trial?
Kaiser PermanenteLead Sponsor
References
Increasing Mental Health Engagement From Primary Care: The Potential Role of Family Navigation. [2020]Early engagement in mental health intervention is critical, yet the vast majority of children who are experiencing mental health concerns are not receiving needed services. Pediatric primary care clinics have been recognized as an ideal setting in which to identify and address mental health problems early, although engagement in mental health services within primary care and in community-based settings remains low. Navigators, or individuals with experience in navigating the mental health system, have been highlighted as promising partners in efforts to improve engagement in mental health services. Navigation has a growing body of research support among adults and in targeting medical concerns, but there has been limited research on integrating family navigators into pediatric primary care settings to address mental health concerns. Despite this gap in the evidence base, we believe there is significant promise for the use of this model in addressing children's mental health needs. In this report, we discuss factors contributing to high levels of unmet mental health needs and low levels of engagement in mental health services, the role that navigators can play in increasing engagement in mental health care, and implications and recommendations related to integrating mental health-focused family navigators into pediatric primary care settings.
Navigation for youth mental health and addictions: protocol for a realist review and synthesis of approaches and practices (The NavMAP standards project). [2022]Mental health and/or addiction (MHA) concerns affect approximately 1.2 million children and youth in Canada, yet less than 20% receive appropriate treatment for these concerns. Youth who do not receive appropriate support may disengage from care and may experience lasting MHA issues. Families of these youth also support them in finding and accessing care. Thus, system supports are needed to help youth and their families find and equitably access appropriate care. Navigation is an innovation in MHA care, providing patient-centred support and care planning that helps individuals and families overcome barriers to care. Despite the increasing availability of navigation services for youth with MHA concerns, practices and models vary, and no single source has synthesised evidence regarding approaches and outcomes for this population into comprehensive standards.
Patient navigators: Mapping the route toward accessibility in health care. [2020]Children and youth with developmental and mental health conditions require a wide range of clinical supports and social services to improve their quality of life. However, few children and youth are currently able to adequately access these clinical, community and social services, and newcomers or those living in poverty are even further disadvantaged. Patient navigator programs can bridge this gap by facilitating connections to social services, supporting family coping strategies and advocating for patient clinical services. Although there are few paediatric-focused patient navigator programs in the literature, they offer the potential to improve short and long-term health outcomes. As social and clinical services, particularly for developmental and mental health conditions, become increasingly complex and restricted, it is important that physicians and policymakers consider implementing patient navigator programs with a rigorous evaluation framework to improve accessibility and health outcomes. This can ultimately facilitate policymakers in creating more equitable resources in challenging fiscal climates.
A Stepped Care Model of Patient Navigation to Enhance Engagement with Perinatal Mental Health Care. [2020]During the perinatal period, women are at increased risk for developing perinatal mood and anxiety disorders (PMADs). As perinatal mental health screening efforts increase, significantly more women will be identified who require mental health services. Evidence-based treatments exist, yet many women do not receive adequate care. Patient navigation (PN) offers a promising patient-centered approach to improve treatment attendance and engagement. The purpose of this study is to describe the development of a stepped care PN service at an intensive outpatient program for women with PMADs. Our experience incorporating this model of PN revealed significant features that may guide other treatment care facilities to adopt this service to increase identification and connection to care.
Primary care provider utilization and satisfaction with a health system navigation program for adolescents with behavioral health needs. [2020]Approximately 49.5% of the adolescents report a mental health disorder; only about half of the children and adolescents with mental health disorders seek treatment from a mental health professional. Stigma and poor access to behavioral health providers are leading barriers to care. A large ambulatory health system implemented a BH navigation program to facilitate referrals from primary care physicians (PCPs), including pediatricians and family physicians, to BH providers. We studied PCP adoption of BH navigation services over a 4-year period, from July 2014 to June 2018. We retrieved operational data regarding service utilization, patient information from electronic health records and PCP information from administrative data, and surveyed PCPs for their appraisals of navigation services. Four thousand five hundred and fifty-five referrals were made for 3,912 patients from 290 PCPs (71% of PCPs in the health system). Depression (39%), anxiety (25%), and attention-deficit hyperactivity disorder (7%) were the most frequent reasons for referral. Referrals increased dramatically in the first half of the study period and decreased afterwards. Ninety-one percent of the PCPs agreed or strongly agreed that navigation enhanced their clinical care at 12-month survey. More than 90% of the PCPs rated the referral process, communication with navigation staff, and the overall experience as above average or excellent at 12 months. There was a decrease in these evaluation indicators after 2.5 years. The initial high referral volume reflects a need for BH navigation services. However, challenges remain to maintain positive PCP assessment in the face of such demand.
Efficacy and safety of lamotrigine in pediatric patients. [2018]Accumulating data suggest that lamotrigine, which has been available for adult use in epilepsy for more than a decade in clinical practice, also confers effective, well-tolerated control of a range of childhood epilepsies. Lamotrigine is currently approved for the treatment of epilepsy by regulatory authorities in 93 countries, more than 70 of which have approved its use in pediatric patients on the basis of data from well-controlled clinical trials. The controlled clinical trials data have been supplemented over the years by clinical practice data, primarily from uncontrolled studies, confirming or demonstrating additional efficacy of lamotrigine for a range of seizure types. This article reviews the data from well-controlled clinical trials and studies conducted in clinical practice to present an updated perspective on the efficacy and safety of lamotrigine in pediatric patients.
Lamotrigine adjunctive therapy in childhood epileptic encephalopathy (the Lennox Gastaut syndrome). [2019]We assessed efficacy and safety of adjunctive lamotrigine (LTG) therapy in patients with the Lennox-Gastaut syndrome (LGS).
Stable dosages of clobazam for Lennox-Gastaut syndrome are associated with sustained drop-seizure and total-seizure improvements over 3 years. [2022]To determine long-term safety and efficacy of adjunctive clobazam for patients with Lennox-Gastaut syndrome (LGS).
Clinical efficacy of zonisamide in Lennox-Gastaut syndrome: Korean multicentric experience. [2018]To evaluate the efficacy and safety of zonisamide (ZNS) as long-term adjunctive therapy in children with Lennox-Gastaut syndrome (LGS).
Safety and tolerability of lamotrigine: results from 12 placebo-controlled clinical trials and clinical implications. [2022]The mechanism of action of lamotrigine depends on voltage-sensitive sodium channels by which the neuronal membrane is stabilized and the release of excitatory neurotransmitters, such as glutamate and aspartate, is inhibited. Lamotrigine is indicated for maintenance treatment of bipolar I disorder to delay the time to the occurrence of mood episodes for those treated for acute mood episodes with standard therapy. There are significant gaps between clinical practices and research settings; data from controlled clinical trials of lamotrigine provide essential information about safety in bipolar populations because they result from large samples of patients with a specific disease and include comparisons with placebo or other comparators with randomized designs. In addition, lamotrigine's safety and tolerability data differ slightly in relation to disease entities, age ranges of the patients taking lamotrigine, and treatment conditions. For example, the incidence of serious rashes, including Stevens-Johnson syndrome, is approximately 0.8% (8/1000) in pediatric patients (2-16 years of age) receiving lamotrigine as adjunctive therapy for epilepsy and 0.3% (3/1000) in adults on adjunctive therapy for epilepsy. In clinical trials of bipolar and other mood disorders, the rate of serious rash was 0.08% (0.8/1000) in adult patients receiving lamotrigine as initial monotherapy and 0.13% (1.3/1000) in adult patients receiving lamotrigine as adjunctive therapy. Hence, in this study, we focus on the data regarding the safety and tolerability of lamotrigine in the treatment of bipolar disorder gathered from 12 placebo-controlled trials, regardless of publication status, that were sponsored by GlaxoSmithKline. We also inform clinicians of practical issues in safety and tolerability in the use of lamotrigine in the treatment of bipolar disorders.
A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial. [2023]Youth in the child welfare system (child welfare-involved [CWI] youth) have high documented rates of mental health symptoms and experience significant disparities in mental health care services access and engagement. Adolescence is a developmental stage that confers increased likelihood of experiencing mental health symptoms and the emergence of disorders that can persist into adulthood. Despite a high documented need for evidence-based mental health services for CWI youth, coordination between child welfare and mental health service systems to increase access to care remains inadequate, and engagement in mental health services is low. Navigator models developed in the health care field to address challenges of service access, fragmentation, and continuity that affect the quality of care provide a promising approach to increase linkage to, and engagement in, mental health services for CWI youth. However, at present, there is no empirically supported mental health navigator model to address the unique and complex mental health needs of CWI youth and their families.
Evaluating the pediatric mental health care continuum at an American health system. [2023]To describe trends in the pediatric mental health care continuum and identify potential gaps in care coordination.