The Safety-Net Approach

NCT04675567 | Completed

• 1 other identifier: 1H79SM082987
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Disturbances; Behavior Disorders; Mental Disorders, Severe

Outcome Measures

Primary Outcomes (5)

• Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score

  Measurement of clinical functioning using Child and Adolescent Functional Assessment Scale (CAFAS). Trends from baseline to 6 months and 12 months will be examined to identify improvement, decline, or no change in clinical functioning. The CAFAS measure indicates the level of clinical functioning, on a scale of 0-140, where scores above 40 indicate clinical need.

  Comparative analysis of baseline and follow-up clinical functioning scores (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)

• Changes in Children's Global Assessment Scale (CGAS) Score

  Measurement of clinical functioning using Children's Global Assessment Scale (CGAS). Trends from baseline to 6 months and 12 months will be examined to identify improvement, decline, or no change in clinical functioning. The CGAS measure provides a single global rating only, on scale of 0-100, where scores below 60 indicate clinical need.

  Comparative analysis of baseline and follow-up clinical functioning scores (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)]

• Family perceptions of care using the Family Professional Partnership Scale (FPPS).

  Qualitative assessment of family perceptions of care using the Family Professional Partnership Scale (FPPS). The anchors of items rated on satisfaction are rated on a 5-point likert scale, where 1 = very dissatisfied, 3 = neither satisfied nor dissatisfied, and 5 = very satisfied wherein the higher the value represents a better outcome.

  Analysis of baseline and follow-up family perceptions of care (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)]

• Access to child mental health and substance abuse (MH/SA) care

  Comparing service Use Data from Electronic Health Records and Claims for intervention group versus controls

  Comparative analysis of access to care trends (0-6 months)

• Engagement in child mental health and substance abuse (MH/SA) treatment

  Comparing service Use Data from Electronic Health Records and Claims for intervention group versus controls

  Comparative analysis of service use trends (6-12 months)

Study Arms (2)

Safety-Net Intervention

ACTIVE COMPARATOR

Behavioral: Safety-Net Care Team Model

Treatment as Usual

NO INTERVENTION

Interventions

Safety-Net Care Team Model 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.

Safety-Net Intervention

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cambridge Health Alliance: lead

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02141, United States

Location

MeSH Terms

Conditions

Affective Symptoms; Mental Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Psychiatry; Director, Children's Health Initiative

Model Details: The Safety-Net Model consists of the delivery of intensively integrated clinical care within pediatrics, combined with community-based parent support from family support specialists. Innovations include child mental health specialists joining the pediatrics team for "huddles", psychiatry notes shared with pediatricians via the Electronic Medical Records and active inclusion of pediatricians in pre-evaluation discussions with the Safety-Net Team and post-evaluation recommendations for the families. In addition, the Safety-Net model includes active communication with school personnel, child welfare, and community-based resources, when needed.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 19, 2020
• Study Start: March 17, 2021
• Primary Completion: July 31, 2024
• Study Completion: January 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)