The Safety-Net Approach (Safety-Net)
Primary Purpose
Emotional Disturbances, Behavior Disorders, Mental Disorders, Severe
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety-Net Care Team Model
Sponsored by
About this trial
This is an interventional health services research trial for Emotional Disturbances
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)
Sites / Locations
- Cambridge Health AllianceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Safety-Net Intervention
Treatment as Usual
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04675567
First Posted
December 1, 2020
Last Updated
August 22, 2023
Sponsor
Cambridge Health Alliance
1. Study Identification
Unique Protocol Identification Number
NCT04675567
Brief Title
The Safety-Net Approach
Acronym
Safety-Net
Official Title
The Safety-Net Approach: Weaving a Community-based System-of-Care to Improve Child Mental Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
September 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge Health Alliance
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Disturbances, Behavior Disorders, Mental Disorders, Severe
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Safety-Net Intervention
Arm Type
Active Comparator
Arm Title
Treatment as Usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Safety-Net Care Team Model
Intervention Description
"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.
Primary Outcome Measure Information:
Title
Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score
Description
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.
Time Frame
Comparative analysis of baseline and follow-up clinical functioning scores (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)
Title
Changes in Children's Global Assessment Scale (CGAS) Score
Description
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.
Time Frame
Comparative analysis of baseline and follow-up clinical functioning scores (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)]
Title
Family perceptions of care using the Family Professional Partnership Scale (FPPS).
Description
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.
Time Frame
Analysis of baseline and follow-up family perceptions of care (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)]
Title
Access to child mental health and substance abuse (MH/SA) care
Description
Comparing service Use Data from Electronic Health Records and Claims for intervention group versus controls
Time Frame
Comparative analysis of access to care trends (0-6 months)
Title
Engagement in child mental health and substance abuse (MH/SA) treatment
Description
Comparing service Use Data from Electronic Health Records and Claims for intervention group versus controls
Time Frame
Comparative analysis of service use trends (6-12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine E Grimes, MD, MPH
Phone
617-806-8718
Email
katherine_grimes@hms.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer McNaboe, MPH
Phone
8605397205
Email
jemcnaboe@gmail.com
Facility Information:
Facility Name
Cambridge Health Alliance
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer McNaboe, MPH
Phone
617-806-8719
Email
jmcnaboe@challiance.com
First Name & Middle Initial & Last Name & Degree
Katherine E Grimes, MD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Safety-Net Approach
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