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CompletedNCT03336892Updated Feb 23, 2021

Mental Health Care Coordination for Transition Aged Youth

An interventional study of Mental Health Care Coordination in Mental Health, sponsored by Children's National Research Institute. Completed. Open to participants aged 16 Years to 22 Years. Per ClinicalTrials.gov, last updated 2021-02-23.

Sponsored by Children's National Research Institute · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Apr 2016, registered Oct 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
16 Years to 22 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mental Health

Keywords

  • Care Coordination
03

In context

Psychological Well-Being

2,195 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.

This study's enrollment of 220 is above the median of 110 across 1,798 interventional studies indexed under Psychological Well-Being.

Browse Psychological Well-Being studies →

Lead sponsor

Children's National Research Institute is the lead sponsor of 127 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 22 Years
Sexes eligible
All
Accepts healthy volunteers
No

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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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
220 participants (actual)

Study arms

  • 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

  • No intervention
    Control

    Enhanced usual care with written mental health resources and system navigation information.

Interventions

  • BehavioralMental 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.

06

What researchers measure

Primary outcomes

  1. Connection to mental healthcare

    Number of study participants self-reported receiving mental health care services since enrollment

    Time frame: 2 years

Secondary outcomes

  1. Patient Experiences

    Experience of Care and Health Outcomes (ECHO) Survey

    Time frame: 2 years

  2. Depression symptoms

    PHQ-9 Questionnaire

    Time frame: 2 years

  3. Mental Health Stigma

    Internalized Stigma of Mental Illness (ISMI) Questionnaire

    Time frame: 2 years

  4. Patterns of substance use

    Youth Risk Behavior Survey (YRBS) Questionnaire

    Time frame: 2 years

  5. Adverse Childhood Events

    Philadelphia ACE Survey

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2016 to primary completion in Mar 2019, 35 months.

Of 1,261 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's 35 months is above that.

Counting every sponsor, half of 1,304 studies reached it within 16 months; a quarter within 7 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2017
First posted
Nov 8, 2017
StartActual
Apr 1, 2016
Primary completionActual
Mar 31, 2019
CompletionActual
Oct 31, 2019
Last update
Feb 23, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03336892
Collaborators
Health Resources and Services Administration (HRSA)
Responsible party
Lisa Tuchman (Principal Investigator, Children's National Research Institute) — Principal investigator
First posted
Nov 8, 2017
Start date
Apr 1, 2016
Primary completion
Mar 31, 2019
Completion
Oct 31, 2019
Last update
Feb 23, 2021

Study contacts

Lisa K Tuchman, MD, MPH
principal investigator · Children's National Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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