NCT03637478

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

2.8 years

First QC Date

July 19, 2018

Last Update Submit

October 19, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

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

    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

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

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

Secondary Outcomes (3)

  • Family Care Experience

    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

    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

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

Study Arms (1)

Enhanced Systems of Care Team

EXPERIMENTAL

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

Interventions

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.

Enhanced Systems of Care Team

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • years or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge Health Alliance

Cambridge, Massachusetts, 02141, United States

Location

Study Officials

  • Katherine E Grimes, MD, MPH

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The E-SOC 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 E-SOC Team and post-evaluation recommendations for the families. In addition, the E-SOC model includes active communication with school personnel, child welfare, and community-based resources, when needed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Children's Health Initiative

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 20, 2018

Study Start

October 17, 2017

Primary Completion

July 31, 2020

Study Completion

September 30, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations