Enhancing Systems of Care: Supporting Families and Improving Youth Outcomes (E-SOC)

October 19, 2020 updated by: Katherine Grimes MD, Cambridge Health Alliance
The aim of the study is to improve access to child mental health and substance abuse (MH/SA) care by expanding primary care screening and increasing availability of timely mental health evaluation and treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a quasi-experimental, longitudinal study. Identified youth and families will receive the intervention within the four study site clinic locations. Comparison group families will receive usual care. Each primary care study site will have designated Family Support Specialist, Clinical Care Manager and Child Psychiatry resources. The intervention includes an integrated care consultation which combines diagnostic evaluation, family assessment, and multi-disciplinary, team-based treatment recommendations, with follow-up community linkages and support, as indicated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
171

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02141
        • Cambridge Health Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be between ages 0 to 17.5 years
  • Referred by primary care physician at one of these Cambridge Health Alliance clinics: Windsor Street Care Center, Broadway Care Center, Everett Care Center, Malden Family Medicine Center
  • Referred youth must have a caregiver (a parent of guardian) who agrees to participate in the assessment and treatment process

Exclusion Criteria:

  • 17.6 years or older

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enhanced Systems of Care Team
The four intervention sites have been selected based on their size: taken together, their pediatric populations comprise over 80% of the total number of children receiving care at Cambridge Health Alliance. At the four intervention sites, the study will involve: 1) an integrated child mental health assessment done by the E-SOC team within primary care, 2) active follow-up, collaboration with specialty providers and support to families, 3) School, child welfare and other community linkages as appropriate.
Behavioral: Enhanced Systems of Care Team
E-SOC team will be increasing connections between clinical care and community partners, such as schools, juvenile justice and child-serving state agencies, to reduce disparities in access to mental health/substance use evaluation and treatment. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning. Overall goals are: earlier identification of mental health needs including child trauma; increased treatment access and adherence; care delivered in least restrictive settings; care experience reflecting active youth and family engagement; program sustainability and replicability.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Access to child mental health and substance abuse (MH/SA) care
Time Frame: Comparative analysis of access to care trends (0-6 months)
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
Time Frame: Comparative analysis of service use trends (6-12 months)
Service Use Data from Electronic Health Records and Claims for intervention group versus controls
Comparative analysis of service use trends (6-12 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Family Care Experience
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.
Analysis of baseline and follow-up family perceptions of care (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)
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.
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 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.
Comparative analysis of baseline and follow-up clinical functioning scores (baseline collected at enrollment, follow-up assessments collected at 6 months and 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cambridge Health Alliance

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine E Grimes, MD, MPH, Cambridge Health Alliance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHR-IRB-1062/04/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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