The Safety-Net Approach

NCT ID: NCT04675567

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2025-01-31

Brief Summary

The Safety-Net project, is intended to disrupt disparities in mental health treatment access for children at-risk for childhood trauma (ACEs) and/or serious emotional disturbance (SED). "Safety Net" will use mobile clinical and family support teams to improve mental health outcomes. This clinical innovation, nested in an integrated system-of-care will be piloted for children, ages 3-18 yrs., with SED who receive primary care through Cambridge Health Alliance.

Detailed Description

The Safety-Net project, is intended to disrupt disparities in mental health treatment access for children at-risk for childhood trauma (ACEs) and/or serious emotional disturbance (SED). "Safety Net" will use mobile clinical and family support teams to improve mental health outcomes. This clinical innovation, nested in an integrated system-of-care will be piloted for children, ages 3-18 yrs., with SED who receive primary care through Cambridge Health Alliance. Massachusetts had the highest rate of child abuse and neglect in the US during 2016 (DHHS, 2017). Approximately, 25% of these children live below the federal poverty level (American Community Survey, 2011-2013). The "gateway" cities this study targets in Metro-Boston (Malden and Everett) have 2-3 times the rate of foreign-born residents (43% vs. 15%) compared to the rest of the MA, and twice the statewide rate of children whose parental language is not English (54% vs. 22.3%). Together, SED and ACEs put children at much higher risk for adverse health and mental health outcomes in childhood and beyond.

CHA's Children's Health Initiative (CHI) leadership will combine evidence-based interventions from its earlier MHSPY program (family support, care management and shared goals) with new strategies, such as interdisciplinary child mental health evaluation teams, all within primary care. Clinical expertise will be combined with peer-to-peer parent/guardian support for trauma-informed care delivery to both parent and child. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning. Overall, the program will be sited in two cities, supported by a larger, specialized system of care involving state and local child serving agencies, schools and community-resources. The study team anticipates serving 248 children and families in total, at approximately 70 children per year. Program goals include: 1) Promote earlier recognition of child mental health needs; 2) Family-driven assessment approach to offset disparities in treatment engagement and outcomes; 3) Facilitate state, local and care planning team coordination and collaboration using SOC principles. Objectives: 1) Assess presence of SED (Serious Emotional Disturbance) via Standardized measures of Clinical Functioning (CGAS and CAFAS) 2) Screen for adverse childhood experiences (ACEs) by use of modified ACE-Q tool, 3) Increase access to child mental health evaluation and treatment using Pre-post measures of patterns of service use for study participants and Assessment of patterns of care for propensity-score weighted comparison group, 4) Improve family care experience, as measured by Baseline and follow-up Family Professional Partnership Scale assessments, 5) Improve clinical functioning, as measured by Baseline and follow-up CGAS and CAFAS assessments. Safety-Net's goals align with CHA's goals within its Accountable Care Organization contract with MassHealth, thus offering a chance to measure and evaluate outcomes for a customized system-of-care for some of the state's most vulnerable populations.

Conditions

Emotional Disturbances; Behavior Disorders; Mental Disorders, Severe

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Safety-Net Intervention

Group Type: ACTIVE_COMPARATOR

Safety-Net Care Team Model

Intervention Type: BEHAVIORAL

"Safety-Net" Care Planning Team: Clinical expertise will be combined with peer-to-peer parent/guardian support for trauma-informed care delivery to both parent and child. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning.

Treatment as Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Safety-Net Care Team Model

"Safety-Net" Care Planning Team: Clinical expertise will be combined with peer-to-peer parent/guardian support for trauma-informed care delivery to both parent and child. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 3 through 18 years (17½ years maximum at time of enrollment)
• 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.
• Positive screen on CHA's standard pediatric mental health and substance use screening instruments, and/or parental concern about possible mental health/substance use needs, and/or PCP concern about possible mental health/substance use needs
• Enrolled in MassHealth

Exclusion Criteria

• Subjects over 17.5 years (SAMHSA data collection required at 6 and 12 months after enrollment which must occur before age 18 years.)
• 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)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge Health Alliance

OTHER

Sponsor Role: lead

Responsible Party

Katherine Grimes MD

Associate Professor, Psychiatry; Director, Children's Health Initiative

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cambridge Health Alliance

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

1H79SM082987

Identifier Type: -

Identifier Source: org_study_id