Safety-Net Care Team Model for Emotional Disturbance

(Safety-Net Trial)

Overseen By Jennifer McNaboe, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Cambridge Health Alliance

Disqualifiers: Over 17.5 years, Not MassHealth, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve mental health care for children at risk of childhood trauma or with serious emotional disturbances. It will test a new approach using mobile clinical and family support teams, known as the Safety-Net Care Team Model, to enhance mental health outcomes. Participants will either receive this new intervention or continue with their usual treatment. Children aged 3 to 18 who receive primary care at specific Cambridge Health Alliance sites and are enrolled in MassHealth are eligible if they show signs of mental health or substance use issues. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative mental health care solutions for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Safety-Net Care Team Model is safe for children with serious emotional disturbance?

Research has shown that the Safety-Net Care Team Model aims to improve mental health by using mobile teams to support families. However, no specific studies directly assess the safety of this model. The trial is marked as "Not Applicable" for its phase, indicating a focus on service delivery rather than testing a new drug or device, which involves different safety considerations.

Service models like this generally combine care and support, involving low-risk activities such as counseling and coordinating care. Reports of major negative effects from similar models are absent, as they primarily aim to improve access to mental health services. This model is designed to help children with serious emotional issues, aiming for better mental health outcomes without using medical treatments that have significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Safety-Net Care Team Model for emotional disturbance because it offers a comprehensive, team-based approach to mental health care. Unlike traditional treatments that might focus on medication or individual therapy alone, this model integrates various healthcare professionals to provide coordinated care, potentially addressing a wider range of patient needs in a more holistic way. This approach can lead to more personalized support and better outcomes for patients, especially those who might face barriers to accessing mental health services.

What evidence suggests that the Safety-Net Care Team Model is effective for serious emotional disturbance?

Research has shown that combining mental health services with regular doctor visits can greatly improve mental health. This trial tests the Safety-Net Care Team Model, which uses mobile teams to support children's mental health, as an intervention for those with serious emotional issues. Studies have found that similar combined approaches can make mental health care more accessible and improve well-being. For example, some health centers have successfully integrated mental and regular health care, leading to better patient outcomes. This suggests that the Safety-Net model could effectively help children with serious emotional problems by providing more comprehensive and accessible care. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for children aged 3-17.5 years who are enrolled in MassHealth and have been referred by their primary care physicians from specific CHA sites due to concerns about mental health or substance use. They must show positive signs on standard screening tools or parental/PCP concern.

Inclusion Criteria

You have shown signs of mental health or substance use issues based on a screening test, or your parents or doctor are concerned about your mental health or substance use.

I am between 3 and 17½ years old.

Referred by PCP's from one of the three CHA Safety Net primary care sites (Malden Family Medicine Center, Windsor Street Health Center and Broadway Care Center) to the Safety Net team for an integrated child mental health and/or substance use disorder clinical assessment.

Exclusion Criteria

I am 17.5 years old but will not turn 18 before enrolling.

Youth who are not enrolled in MassHealth

CHA patients with PCP located at CHA primary care site other than three identified intervention sites (Malden, Windsor, Broadway)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mobile clinical and family support interventions to improve mental health outcomes

12 months

Regular visits as needed for intervention delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 6 months and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Safety-Net Care Team Model

Trial Overview The 'Safety-Net Care Team Model' aims to improve mental health outcomes for at-risk children with serious emotional disturbances by using mobile clinical and family support teams integrated within the healthcare system.

How Is the Trial Designed?

Group I: Safety-Net Intervention Active Control 1 Intervention

Group II: Treatment as Usual Active Control 1 Intervention

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04675567

Study Details | NCT04675567 | The Safety-Net Approach "Safety Net" will use mobile clinical and family support teams to improve mental health outcomes. This clinical innovation, nested in an integrated system-of- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9012483/

Integrating Mental Health in Safety-net Primary Care Multilevel regression models used MHIP implementation to predict odds of visits being associated with psychiatric diagnoses, controlling for time, clinic, and ...

3. chwsny.org chwsny.org/wp-content/uploads/2019/02/OHWRC_Case_Studies_Oral_and_Behavioral_Health_Integration_With_Primary_Care_2019.pdf

Case Studies of 6 Safety Net Organizations That Integrate ... This report describes efforts in federally qualified health centers to integrate oral and mental/behavioral health with primary care, using case studies of 6 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6381518/

Creating a safety net for patients with depression in primary ... The aim of this study was to explore nurses' experiences and perceptions of working as care managers at primary care centers.

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0320843

Protocol for a hybrid effectiveness-implementation study The 3 Wishes Project (3WP) is a low-cost intervention that aims to enhance compassionate end-of-life (EOL) experiences by empowering the clinical team.

6. eohhs.ri.gov eohhs.ri.gov/sites/g/files/xkgbur226/files/2025-08/DRAFT%20Children%27s%20BH%20Safety%20Net%20Vision%20Updated%207.29.25.pdf

Children's Behavioral Health Crisis Planning Team And the. Safety Net must include a coordinated continuum of services addressing substance use, for both youth and their caregivers, including ...