A Family-Based Mental Health Navigator Intervention for Youth in the Child Welfare System: Protocol for a Randomized Controlled Trial

Background 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. Objective Using a randomized controlled trial, this study aims to develop and test a foster care family navigator (FCFN) model to improve mental health service outcomes for CWI adolescents (aged 12-17 years). Methods The navigator model leverages an in-person navigator and use of adjunctive digital health technology to engage with, and improve, care coordination, tracking, and monitoring of mental health service needs for CWI youth and families. In total, 80 caregiver-youth dyads will be randomized to receive either the FCFN intervention or standard of care (clinical case management services): 40 (50%) to FCFN and 40 (50%) to control. Qualitative exit interviews will inform the feasibility and acceptability of the services received during the 6-month period. The primary trial outcomes are mental health treatment initiation and engagement. Other pre- and postservice outcomes, such as proportion screened and time to screening, will also be evaluated. We hypothesize that youth receiving the FCFN intervention will have higher rates of mental health treatment initiation and engagement than youth receiving standard of care. Results We propose enrollment of 80 dyads by March 2024, final data collection by September 2024, and the publication of main findings in March 2025. After final data analysis and writing of the results, the resulting manuscripts will be submitted to journals for dissemination. Conclusions This study will be the first to produce empirically driven conclusions and recommendations for implementing a family mental health navigation model for CWI youth with long-standing and unaddressed disparities in behavioral health services access. The study findings have potential to have large-scale trial applicability and be feasible and acceptable for eventual system implementation and adoption. Trial Registration ClinicalTrials.gov NCT04506437; https://www.clinicaltrials.gov/study/NCT04506437 International Registered Report Identifier (IRRID) DERR1-10.2196/49999


DESCRIPTION (provided by applicant):
Youth in the child welfare system have documented high rates of mental health symptoms and experience significant disparities in mental health care services access and engagement relative to youth not in the child welfare system.Navigator models have been developed in the healthcare field to address challenges of service access, fragmentation and continuity that impact quality of care, but at present there is no empirically supported mental health navigator model to address the unique and complex mental health needs of child welfare involved (CWI) youth.This developmental study will be conducted in three phases consistent with study aims.The study will take a mixed-methods, multi-informant participatory research approach to developing, iteratively refining and pilot testing a Foster Care Family Navigator (FCFN) model to improve mental health service outcomes for adolescents (ages 12-17) involved in the child welfare system.The navigator model will leverage digital health technology to engage with and improve care coordination, tracking and monitoring of mental health service needs for these youth and families.The study will adapt the JJ-TRIALS Behavioral Health Services Cascade framework to support a data-driven decision-making approach to improving identification of mental health service needs and outcomes.The study will first utilize a combination of interagency collaborative meetings, youth and family focus groups and qualitative individual interviews with multisystem stakeholders to guide the development of the FCFN protocol.Next an open trial of the 6-month FCFN intervention will be conducted and the protocol iteratively refined through direct participant feedback.The last phase of the study will focus on conducting a modified roll-out design of the FCFN intervention with 75 child welfare involved youth.Three cohorts of 25 youth and caregivers each will receive FCFN services for 6 months and will be compared on primary outcomes of mental health initiation and engagement to 50 youth and caregivers who receive services as usual.We will explore mediators (e.g., satisfaction with navigator, youth treatment motivation, perceived barriers to care) and moderators (e.g., race, ethnicity, sex) of intervention impact to inform intervention mechanisms of change and key demographic and other contextual factors associated with trial outcomes.Finally, we will also conduct qualitative exit interviews with trial participants and navigators to gain a deeper understanding of influences on pilot outcomes that can inform future larger efficacy and effectiveness trials.

PUBLIC HEALTH RELEVANCE
Youth in the child welfare system have documented high rates of mental health symptoms but experience significant disparities in mental health care services access and engagement.System fragmentation, challenges with treatment engagement and poor coordination and continuity of care exacerbate existing disparities.We propose to develop and test a Foster Care Family Navigator intervention that leverages multisystem collaboration and digital health technology to improve child welfare-involved youths&apos; mental health service access, initiation and engagement.

Overall Impact:
The intention of this study is to use a mixed-methods, multi-informant participatory research approach to develop and refine a Foster Care Family Navigator (FCFN) model to improve mental health service outcomes for adolescents (ages 12-17) involved in the child welfare system.This is a strong, wellwritten application submitted by an experienced investigative team, and the resubmission is very responsive to the previous reviews.The topic is important and responsive to the funding opportunity announcement.A few minor concerns remain that could benefit from additional clarification, as are detailed below.

Significance: Strengths
• The team has chosen to focus on an important population, namely youth in the child welfare system, given that these youth often experience rates of mental health symptoms and experience significant disparities in mental health care services access and engagement.
• Attention devoted to racial and ethnic minority system-involved youth.

Investigator(s): Strengths
• The PI has expertise in mental health, substance use and HIV prevention related research with vulnerable, marginalized populations, as well as several publications and extensive grant experience.
• A more thorough discussion of the role and responsibilities of each co-I well as a discussion of possible overlap of expertise have been added, which strengthen the application.
• Co-I (Shumway) will offer expertise in measurement, statistics, and intervention trials in community settings.Weaknesses • None.

Innovation: Strengths
• Use of a dynamic waitlist design.
• Use of existing system and resources. Weaknesses • None.

Approach: Strengths
• Use of innovative M Health.
• Building the approach with stakeholders and within an existing system.
• UCSF staff are already embedded into the service setting.
• Using staff members who are already part of the service setting structure (e.g., Pod leaders) is great for integration and sustainability.Weaknesses • A discussion has been added about strengths of including staff members who are already part of the service setting structure (e.g., Pod leaders), which is helpful.It also might have been helpful to more fully discuss how generalizable this structure and the role of the pod leaders are to other systems.
• Will an emphasis be placed on referrals to EBPs?There is mention that these services are available in the community?Will that be tracked?

Environment: Strengths
• The environment is outstanding.
• Easy access to a strong network of colleagues.
• Strong letters of support are included.
• The timeline is ambitious, but now scaled back and reasonable within the timeframe and grant mechanism.

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections • A clear, detailed plan was provided.

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only):
Acceptable.
• A clear, detailed plan was provided.

Inclusion of Women, Minorities and Children:
• Sex/Gender: Distribution justified scientifically • Race/Ethnicity: Distribution justified scientifically • For NIH-Defined Phase III trials, Plans for valid design and analysis: • Inclusion/Exclusion of Children under 18: Including ages <18; justified scientifically • A clear, detailed plan is provided.The investigative team has been quite thoughtful about race, ethnicity and gender inclusion details and has confirmed that with their community partners, as is detailed in the application.

Vertebrate Animals:
Not Applicable (No Vertebrate Animals).

Resubmission:
• The resubmission is responsive to the previous review and is substantially improved.

Applications from Foreign Organizations:
Not Applicable (No Foreign Organizations).

Select Agents:
Not Applicable (No Select Agents).

Resource Sharing Plans:
Acceptable.

Authentication of Key Biological and/or Chemical Resources:
Not Applicable (No Relevant Resources).

CRITIQUE 2
Significance: 2 Investigator(s): 2 Innovation: 1 Approach: 4 Environment: 1 Overall Impact: This is a resubmission of an R34 application responding to PAR-18-429, calling for pilot studies to develop and pilot test the effectiveness and implementation of family navigator models to increase early access, engagement, and coordination of mental health services for children.The application proposes to develop, with extensive stakeholder engagement, the Foster Care Family Navigator (FCFN) model, targeting the population of youth and caregivers who are child welfare involved (CWI).This population is disproportionately at risk for mental health issues and also underserved.The proposed study has many strengths.It addresses a significant need, involves a team of investigators with relevant and complementary expertise, is innovative in multiple ways (including the integration of a digital health platform as part of the FCFN model), proceeds through three stages of intervention development and testing, specifies hypothesized mechanisms of change and their measures, and benefits from an exceptionally strong academic environment and collaborations with stakeholders across systems.A moderate concern exists regarding the timing and placement of the FCFN model within the unit responsible for conducting mental health screenings of referred CWI youth and caregivers; if youth and caregivers present for screening, it seems that they would have already negotiated many of the barriers to services that navigation models are intended to overcome.Additionally, given the strong collaborations and processes already in place in the systems involved in this study, it is not fully clear that the FCFN model would be easily implementable in "typical" settings.Finally, the application does not adequately describe the scope and purpose of the subsequent large-scale trial that this pilot mechanism is intended to prepare for; the third aim of the pilot is described as testing effectiveness and appears to be designed and powered for that purpose.

Significance: Strengths
• Mental health needs are elevated and unmet in the CWI population.• Multi-system stakeholder engagement in intervention development is a major strength -family courts, child welfare, public mental health, schools.
• Racial, ethnic, and socioeconomic disparities are recognized and addressed by focusing on the CWI population.Weaknesses • FCMH relies on child welfare caseworkers to make referrals for mental health screening and assessment.Once youth/caregivers are seen at FCMH, they have already overcome many of the barriers to accessing mental health services.It seems that this point in the process might be late for a family navigator intervention if early identification and engagement in mental health services are the goals.
• Even with the CA laws and the system for referrals in place, only 28% of CWI in San Francisco were assessed within 2 months of case opening, according to the local data cited in the application.Was this a capacity issue, a referral issue, a youth/caregiver follow-up issue?The reason for this is not clearly explained in the application.The point(s) at which the breakdown occurs, resulting in this low rate, should be clear before a new role is added to an already complex system.
• It is not fully clear whether the pod structure and functions at FCMH constitute a "typical" service setting with typically available resources and personnel.The review criteria for this FOA emphasize that the developed intervention/program should be implementable in typical settings with typical resources and personnel -it is difficult to assess whether the pod directors serving as navigators would be available in other settings, whether this role would be compatible with similar positions in other settings, etc.
• Not many details appear to be provided in regard to the larger trial for which the proposed study serves as a pilot.

Investigator(s): Strengths
• The PI is a clinical psychologist with extensive experience with intervention research in vulnerable populations (mostly juvenile justice), family-based interventions, and trauma.
• Co-I Shumway is a quantitative psychologist with expertise in statistics and measurement.
• Co-I Dauria is a behavioral scientist with expertise in qualitative methods.
• Co-I Borsari is a clinical psychologist with expertise in motivational interviewing.
• Co-I/Site PI Berrick (at UC Berkeley) has extensive child welfare expertise with a focus on foster care.
• Co-I Aguilera (at UC Berkeley) is a clinical psychologist with expertise in digital health and the HealthySMS text messaging system proposed for use in this study.Weaknesses • This is a large team of investigators, several of whom have very limited effort devoted to this project and two of whom are at a different institution.
• There appears to be overlap in expertise among several co-Is with little attention to describing the communication/coordination among members of the team; the study team overview reiterates team members' areas of expertise but does not fully clarify how the group will function.

Innovation: Strengths
• JJ-TRIALS Cascade framework is applied to a new context/population.
• Integration of mHealth/texting/dashboard components into the navigation model is innovative.
• There is potential for particularly innovative aspects of the digital components to be used (e.g., geo fencing), depending on target population and stakeholder feedback.Weaknesses • A hybrid type 1 trial does not typically focus on efficacy/effectiveness as stated in the application, but on effectiveness/implementation.
• Figure 4 depicts how the FCFN model is hypothesized to affect mental health services outcomes through specific mechanisms of change.Outcome measures and measures of mechanisms are specified.
• Dynamic wait-listed design is a strength.
• Stakeholders are incorporated into each study phase, increasing the chances of sustainability and progress to a subsequent large-scale effectiveness trial.Weaknesses • Feasibility and acceptability could have been more clearly operationalized; quantitative measures and targets/benchmarks could be specified up front, in addition to the proposed qualitative exit interviews.
• Using discharge date and assessment date to calculate engagement might be problematic if discharges (as in many service settings) do not occur immediately after clients disengage from services.
• It might have been helpful to explain how the team will integrate what is already known about feasible and valid fidelity measurement approaches into the development of a fidelity assessment.
• A missing part of the Cascade seems to be: of those referred for screening, how many were screened?This is linked to the comment under Significance regarding the context and processes underlying only 28% of newly opened cases being screened by 2 months after case opening and the lack of clarity regarding whether referrals are not made or whether referrals are made but screenings do not occur.
• Even at the intervention development phase, preparation for a future trial could have been strengthened by using an implementation science framework to guide assessment of factors which might impact the use and effectiveness of the FCFN model; domains such as intervention characteristics and interventionist characteristics are already touched on in the planned measures, and characteristics of the inner and outer setting could be added relatively easily.
• In regard to feasibility of achieving the proposed aims in the timeline, this mechanism is intended to support pilot trials for larger effectiveness studies.The proposed sample size and analyses for Aim 3 appear more consistent with an effectiveness trial than a pilot.

Environment: Strengths
• Excellent research environments at both institutions.
• Clear support from partnering agencies and stakeholders in the community -strong letters provided.Weaknesses • None noted.

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections • Very comprehensive and clear; kudos for a very thoughtful and detailed HSP section.
• Recommend that navigators should complete human subject's protection training; although they are participants themselves, they will be in contact with youth/caregiver participants.Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): Acceptable.
• Detailed and appropriate.

Resubmission:
• The application is moderately responsive to prior reviews: justification of using the CANS as a screening tool is acceptable; transition from juvenile justice to child welfare population is explained; some increase in investigator effort was apparently made.The response to a reviewer concern regarding disentangling of the effects of various aspects of the intervention (i.e., navigator, MI, and mHealth) is adequate.The issue of generalizability beyond California (due to laws and systems in place in that state) is somewhat addressed, but other generalizabilty concerns remain (i.e., FCMH as the source of youth/caregiver participants will likely yield a sample more likely to have engaged in mental health screening, assessment, and treatment).Insufficient response is provided in regard to the need for a communication/coordination plan, given the number and locations of investigators.

Applications from Foreign Organizations:
Not Applicable (No Foreign Organizations).

Select Agents:
Not Applicable (No Select Agents).

Resource Sharing Plans:
Acceptable.

Authentication of Key Biological and/or Chemical Resources:
Not Applicable (No Relevant Resources).

CRITIQUE 3
1 R34 MH119433-01A1 9 SERV TOLOU-SHAMS, M Significance: 1 Investigator(s): 1 Innovation: 1 Approach: 2 Environment: 1 Overall Impact: This is a significant R34 application that focuses on addressing mental health needs of youth in the child welfare system.To date, there is no evidence supporting the use navigator models to address the unique and complex mental health needs of child welfare involved (CWI) youth.This R34 study would take steps to address this gap.The study will iteratively refine and pilot test a Foster Care Family Navigator (FCFN) model to improve mental health service outcomes for adolescents (ages 12-17) involved in the child welfare system.The model leverages digital health technology (and a data-driven decision-making approach) and stakeholder engagement to develop technology and protocols that aim to improve care coordination, tracking and monitoring of mental health service needs for these youth and families.What is developed is then pilot-tested in the final study aim.This work lays the foundation for a larger effectiveness trial.The Introduction to this Resubmission responds to prior concerns in a clear manner.The revisions made to the application strengthen this study and address the weaknesses that previously limited enthusiasm for a highly significant study.

Significance: Strengths
• Strong.Research is needed in this area.

Investigator(s): Strengths
• The investigative team is strong.Changes to FTE for the PI and the tech developer strengthen the investigative team and lend confidence that they have the expertise and time to carry out study activities.

Innovation: Strengths
• This is a highly innovative study.

Approach: Strengths
• The approach is well described and well developed.
• Change to the timelines (and the reduction in sample size) make excellent sense, given that this is a pilot study.
• The revisions made to the evaluation plan and, in particular, how participants will be selected for interviews to assess feasibility and acceptability of the intervention improve the design.

Resubmission:
• This resubmission is highly responsive to the previous review.

Applications from Foreign Organizations:
Not Applicable (No Foreign Organizations).

Select Agents:
Not Applicable (No Select Agents).

Resource Sharing Plans:
Not Applicable (No Relevant Resources).

Authentication of Key Biological and/or Chemical Resources:
Not Applicable (No Relevant Resources).

CRITIQUE 4
Overall Impact: This is a thoughtful and strong application with goals that will improve clinical practice for care of a vulnerable population.All concerns noted in the original application were thoroughly addressed in this application.Given the high rates of disparities in youth in the CWI receiving mental health care as compared to youth not in CWI receiving mental health care, this is a critical area of need and one that should be addressed.The navigator model that is proposed by the investigator indicates the 1 R34 MH119433-01A1 11 SERV TOLOU-SHAMS, M importance of coordinated and collaborative interagency work.Given the success of navigator models in other populations such as cancer, the foster care navigator is co-develops intervention with other important agencies involved with these patients.They added another layer of engagement by incorporating state of the art mobile health technology.The chances of successful outcomes are strengthened by conducting participatory research with all key stakeholders.Since our existing mental health navigation models do not take into consideration systems-involved youth, the proposal of codeveloping the navigator approach with interagency collaboration has the potential to positively change treatment and understanding of mental health conditions in foster care youth.
The study procedures are safe and tolerable without being burdensome especially with the incorporation of m-health.One of the most important strengths of this proposed study is the use of stakeholder engagement throughout the study.The focus groups with CWI youth and families are a strong example of this.In addition, meeting the foster youth and families and agency stakeholder members to a schedule that is flexible to them allows for greater rates of recruitment and retention.The recruitment and retention strategies the investigator proposes are reasonable.In summary, this is a strong resubmission that includes strong stakeholder engagement to test a navigator model for foster youth that if successful will make a major contribution to the mental health care of this vulnerable population.

Protections for Human Subjects:
Acceptable Risks and/or Adequate Protections Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): Acceptable.

Inclusion Plans:
• Sex/Gender: Distribution justified scientifically • Race/Ethnicity: Distribution justified scientifically • For NIH-Defined Phase III trials, Plans for valid design and analysis:

COMMITTEE BUDGET RECOMMENDATIONS:
The budget was recommended as requested.
Footnotes for 1 R34 MH119433-01A1; PI Name: TOLOU-SHAMS, MARINA NIH has modified its policy regarding the receipt of resubmissions (amended applications).See Guide Notice NOT-OD-14-074 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-1R34 MH119433-01A1 12 SERV TOLOU-SHAMS, M 14-074.html.The impact/priority score is calculated after discussion of an application by averaging the overall scores (1-9) given by all voting reviewers on the committee and multiplying by 10.The criterion scores are submitted prior to the meeting by the individual reviewers assigned to an application, and are not discussed specifically at the review meeting or calculated into the overall impact score.Some applications also receive a percentile ranking.For details on the review process, see http://grants.nih.gov/grants/peer_review_process.htm#scoring.
• Race/Ethnicity: Distribution justified scientifically • For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable • Inclusion/Exclusion Based on Age: Distribution justified scientifically • Appropriate and scientifically justified.
For NIH-Defined Phase III trials, Plans for valid design and analysis:• Inclusion/Exclusion Based on Age: Distribution justified scientifically

THE FOLLOWING SECTIONS WERE PREPARED BY THE SCIENTIFIC REVIEW OFFICER TO SUMMARIZE THE OUTCOME OF DISCUSSIONS OF THE REVIEW COMMITTEE, OR REVIEWERS' WRITTEN CRITIQUES, ON THE FOLLOWING ISSUES: PROTECTION OF HUMAN SUBJECTS: ACCEPTABLE INCLUSION OF WOMEN PLAN: ACCEPTABLE INCLUSION OF MINORITIES PLAN: ACCEPTABLE INCLUSION OF CHILDREN PLAN: ACCEPTABLE.
• Inclusion/Exclusion Based on Age: Distribution justified scientifically Adolescents (age 12-17) involved in foster care and the juvenile justice system are the focus of the application.