Mental HealthNCT03336892
Mental Health Care Coordination for Transition Aged Youth
A study testing Mental Health Care Coordination in people with Mental Health, run by Children's National Research Institute.
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. Read more about this study
- Who is it for?
- Ages 16 to 22 years
- Conditions the study is for
- Mental Health
- What is being tested?
- Mental Health Care Coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- has a diagnosis of serious emotional disturbance/serious mental illness
- has not received outpatient mental health services in the past 30 days
Who cannot join
- does not have a diagnosis of serious emotional disturbance/serious mental illness
- has received outpatient mental health services in the past 30 days
About this study
Official title: 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.
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.
- Conditions
- Mental Health
- Being tested
- Mental Health Care Coordination
- Keywords
- Care Coordination
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Health Care CoordinationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Mental Health Care Coordination |
| Control | No intervention | Enhanced usual care with written mental health resources and system navigation information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connection to mental healthcare
Number of study participants self-reported receiving mental health care services since enrollment
Measured: 2 years
Secondary outcomes (5)
Patient Experiences
Experience of Care and Health Outcomes (ECHO) Survey
Measured: 2 years
Depression symptoms
PHQ-9 Questionnaire
Measured: 2 years
Mental Health Stigma
Internalized Stigma of Mental Illness (ISMI) Questionnaire
Measured: 2 years
Patterns of substance use
Youth Risk Behavior Survey (YRBS) Questionnaire
Measured: 2 years
Adverse Childhood Events
Philadelphia ACE Survey
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start1 Apr 2016
- Primary completion31 Mar 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Responsible party
- Principal investigator, Lisa Tuchman, Children's National Research Institute
- Investigators
- Lisa K Tuchman, MD, MPH, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336892
- Sponsor's protocol ID
- Pro7512
- Other IDs
- R40MC29453
- Status last verified
- Feb 2021
- First submitted
- 23 Oct 2017
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Care Coordination for Transition Aged Youth With Serious Emotional Disturbance/Serious Mental Illness
- ClinicalTrials.gov ID
- NCT03336892
- Acronym / sponsor ID
- Pro7512
- Conditions
- Mental Health
- Keywords
- Care Coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mental Health Care CoordinationEnhanced 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. |
| Control | No intervention | –Enhanced usual care with written mental health resources and system navigation information. |
Who may qualify
- Ages
- 16 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- has a diagnosis of serious emotional disturbance/serious mental illness
- has not received outpatient mental health services in the past 30 days
Key exclusion criteria (2 listed)
- does not have a diagnosis of serious emotional disturbance/serious mental illness
- has received outpatient mental health services in the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Health Care CoordinationEnhanced 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. | Behavioural | Intervention |
Primary outcome
Connection to mental healthcare
Time frame: 2 years
Number of study participants self-reported receiving mental health care services since enrollment
5 secondary outcomes
Patient Experiences
Time frame: 2 years
Depression symptoms
Time frame: 2 years
Mental Health Stigma
Time frame: 2 years
Patterns of substance use
Time frame: 2 years
Adverse Childhood Events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa K Tuchman, MD, MPH principal investigator
Children's National Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Mental Health Care Coordination in people with Mental Health, run by Children's National Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connection to mental healthcare (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.