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Trial record 22 of 224 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

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ClinicalTrials.gov Identifier: NCT03637478
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Katherine Grimes MD, Harvard Medical School

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.

Condition or disease Intervention/treatment Phase
Pediatric Mental Health Services Behavioral: Enhanced Systems of Care Team Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Enhancing Systems of Care: Supporting Families and Improving Youth Outcomes
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637478


Contacts
Contact: Katherine E Grimes, MD, MPH 617-806-8729 katherine_grimes@hms.harvard.edu
Contact: Amna Baig, MPH 617-806-8729 abaig@challiance.org

Locations
United States, Massachusetts
Cambridge Health Alliance Recruiting
Cambridge, Massachusetts, United States, 02141
Contact: Amna Baig, MPH    617-806-8729    abaig@challiance.org   
Principal Investigator: Katherine E Grimes, MD, MPH         
Sponsors and Collaborators
Cambridge Health Alliance
Investigators
Principal Investigator: Katherine E Grimes, MD, MPH Cambridge Health Alliance

Responsible Party: Katherine Grimes MD, Director, Children's Health Initiative, Harvard Medical School
ClinicalTrials.gov Identifier: NCT03637478     History of Changes
Other Study ID Numbers: CHR-IRB-1062/04/17
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No