Emotional DisturbancesSafety-NetNCT04675567
The Safety-Net Approach
A study testing Safety-Net Care Team Model in people with Emotional Disturbances and Behavior Disorders, run by Cambridge Health Alliance at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Emotional Disturbances, Behavior Disorders, Mental Disorders, Severe
- What is being tested?
- Safety-Net Care Team Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2021to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cambridge Health Alliance
Cambridge, Massachusetts, 02141
About this study
Official title: The Safety-Net Approach: Weaving a Community-based System-of-Care to Improve Child Mental Outcomes
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.
Read the 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.
- Being tested
- Safety-Net Care Team Model
- Medical subject headings
- Affective Symptoms, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety-Net Care Team ModelBehavioural
"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.
| Study group | Role | What they receive |
|---|---|---|
| Safety-Net Intervention | Active comparator | Not described Receives: Behavioral: Safety-Net Care Team Model |
| Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Comparative analysis of service use trends (6-12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start17 Mar 2021
- Primary completion31 Jul 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisturbancesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Grimes MD, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675567
- Sponsor's protocol ID
- 1H79SM082987
- Acronym
- Safety-Net
- Status last verified
- Mar 2025
- First submitted
- 1 Dec 2020
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety-Net Approach: Weaving a Community-based System-of-Care to Improve Child Mental Outcomes
- ClinicalTrials.gov ID
- NCT04675567
- Acronym / sponsor ID
- Safety-Net / 1H79SM082987
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Safety-Net Intervention | Active comparator | Behavioral: Safety-Net Care Team Model |
| Treatment as Usual | No intervention | – |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Safety-Net Intervention |
Primary outcome
Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score
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)
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
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)]
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).
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)]
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
Time frame: Comparative analysis of access to care trends (0-6 months)
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
Time frame: Comparative analysis of service use trends (6-12 months)
Comparing service Use Data from Electronic Health Records and Claims for intervention group versus controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety-Net Care Team Model in people with Emotional Disturbances and Behavior Disorders, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Child and Adolescent Functional Assessment Scale (CAFAS) Score (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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.