Mental Health Care Coordination for Transition Aged Youth

February 22, 2021 updated by: Lisa Tuchman, Children's National Research Institute

Mental Health Care Coordination for Transition Aged Youth With Serious Emotional Disturbance/Serious Mental Illness

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.

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

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.

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.
220

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

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

16 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Intervention
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.
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.
No Intervention: Control
Enhanced usual care with written mental health resources and system navigation information.

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
Connection to mental healthcare
Time Frame: 2 years
Number of study participants self-reported receiving mental health care services since enrollment
2 years

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
Patient Experiences
Time Frame: 2 years
Experience of Care and Health Outcomes (ECHO) Survey
2 years
Depression symptoms
Time Frame: 2 years
PHQ-9 Questionnaire
2 years
Mental Health Stigma
Time Frame: 2 years
Internalized Stigma of Mental Illness (ISMI) Questionnaire
2 years
Patterns of substance use
Time Frame: 2 years
Youth Risk Behavior Survey (YRBS) Questionnaire
2 years
Adverse Childhood Events
Time Frame: 2 years
Philadelphia ACE Survey
2 years

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.
Children's National Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Resources and Services Administration (HRSA)

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: Lisa K Tuchman, MD, MPH, Children's National Research Institute

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.
April 1, 2016

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.
March 31, 2019

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.
October 31, 2019

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).
October 23, 2017

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.
November 6, 2017

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.
November 8, 2017

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.
February 23, 2021

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.
February 22, 2021

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.
February 1, 2021

More Information

Terms related to this study

Keywords

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.
  • Pro7512
  • R40MC29453 (Other Grant/Funding Number: HRSA Maternal and Child Health Bureau)

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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