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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03336892
Other study ID # Pro7512
Secondary ID R40MC29453
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2016
Est. completion date October 31, 2019

Study information

Verified date February 2021
Source Children's National Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study seeks to quantify the impact of recommended mental health care coordination practices on patient experiences of care, (i.e. satisfaction, stigma, quality of mental health care), evaluate the efficiency and effectiveness of the intervention (i.e. care coordination, timing, unmet needs), and assess mental health outcomes (i.e. symptoms and functioning, involvement with law enforcement/juvenile justice system; rates of substance use /abuse, service utilization) in a population of 16-22 year-old youth receiving primary care in a D.C. urban academic adolescent medicine practice, using standardized outcome measures.


Description:

In the maternal and child health field, there is increasing awareness of modifiable health conditions that appear early in the life course and impact development and wellness throughout the life span. Special opportunities exist in vulnerable populations with serious mental health conditions to better understand what life course events can facilitate attainment of optimal health and development. One such opportunity is making sure youth with serious emotional disturbance/serious mental illness receive the mental health services they need. Unfortunately, untreated mental illness among adolescents and young adults is a major public health problem. Particularly concerning is the fact that 80% of youth with serious emotional disturbance/serious mental illness are not receiving needed mental health services and unmet mental health needs are even higher among certain populations, including minority youth. Youth with untreated mental health problems face a number of challenges that are exacerbated when left untreated. For example, youth with serious mental illness tend to have more difficulties in school and more involvement with the criminal justice system than their peers. These youth also face more challenges successfully transitioning to adulthood and becoming productive members of society. Untreated mental illness tends to lead to more intensive and costly treatment down the road. There are many barriers to accessing mental health services, including stigma and difficulty navigating a complex mental health system, which contribute to unmet mental health needs. Additionally, youth may be so significantly impaired that expecting them to access mental treatment without some supportive services is unrealistic. In light of these facts, it becomes urgent to implement recommended standards for mental health integration and evaluate their impact on mental health outcomes. The Center for Integrated Health Solutions in a joint Health Resources and Services Administration (HRSA)-Substance Abuse and Mental Health Services Administration (SAMHSA) effort recently released expanded joint principles for behavioral health integration. In this model, coordinated care is defined by primary and behavioral health care provided at different locations in the medical neighborhood, but care is coordinated through enhanced communication across the two disciplines. This report makes available an important standard for establishing integrated mental health care coordination practices within a primary care setting, but also demands careful evaluation. This study seeks to quantify the impact of recommended mental health care coordination practices on patient experiences of care, (i.e. satisfaction, stigma, quality of mental health care), evaluate the efficiency/effectiveness of the intervention (i.e. care coordination, timing, unmet needs), and assess mental health outcomes (i.e. symptoms and functioning, involvement with law enforcement/juvenile justice system; rates of substance use /abuse, service utilization) in a population of 16-22 year-old youth receiving primary care in a D.C. urban academic adolescent medicine practice, using standardized outcome measures.


Recruitment information / eligibility

Status Completed
Enrollment 220
Est. completion date October 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years to 22 Years
Eligibility Inclusion Criteria: - has a diagnosis of serious emotional disturbance/serious mental illness - has not received outpatient mental health services in the past 30 days Exclusion Criteria: - does not have a diagnosis of serious emotional disturbance/serious mental illness - has received outpatient mental health services in the past 30 days

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mental Health Care Coordination
Enhanced usual care with written mental health resources and system navigation information in addition to individualized mental health care coordination by a dedicated specially trained mental health care coordinator.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Children's National Research Institute Health Resources and Services Administration (HRSA)

Outcome

Type Measure Description Time frame Safety issue
Primary Connection to mental healthcare Number of study participants self-reported receiving mental health care services since enrollment 2 years
Secondary Patient Experiences Experience of Care and Health Outcomes (ECHO) Survey 2 years
Secondary Depression symptoms PHQ-9 Questionnaire 2 years
Secondary Mental Health Stigma Internalized Stigma of Mental Illness (ISMI) Questionnaire 2 years
Secondary Patterns of substance use Youth Risk Behavior Survey (YRBS) Questionnaire 2 years
Secondary Adverse Childhood Events Philadelphia ACE Survey 2 years
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