DepressionPhase 1NCT00979524
Addressing Mental Health in African American Job Training Adolescents and Young Adults
A Phase 1 study testing Comprehensive Mental Health Services and Supports in people with Depression, run by Johns Hopkins University at 1 site in United States.
Trial summary
This project's focus is twofold-to change the culture of an employment training program for adolescents and young adults (Youth Opportunities, or "YO") to more fully address the many mental health issues faced by its participants and to expand and improve the quantity and quality of mental health services for YO… Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Comprehensive Mental Health Services and Supports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 782 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2014
- Phase
- Phase 1
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All newly enrolling Eastside and Westside YO members during the study period will be eligible for study participation.
Who cannot join
- We will not enroll YO members currently in foster care in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore City Eastside and Westside Youth Opportunity Centers
Baltimore, Maryland, 21213, 21217
About this study
This project's focus is twofold-to change the culture of an employment training program for adolescents and young adults (Youth Opportunities, or "YO") to more fully address the many mental health issues faced by its participants and to expand and improve the quantity and quality of mental health services for YO members. Four project components have been carefully selected to address the mental health issues of YO members: (1) Mental health education/training for YO staff and peer leaders, (2) Mental health education activities for YO members, (3) mental health screening on all newly enrolling YO members, and (4) comprehensive mental health services for YO members. These project components will be implemented at the HEBCAC YO Program (subsequently referred to as "Eastside" YO), with the Westside YO Program initially participating as a control site. Researchers at the Johns Hopkins University Center for Adolescent Health, led by Dr. Darius Tandon of the Department of Pediatrics, will conduct the research examining the effectiveness of these mental health services and supports.
There are four project objectives. First, the proposed activities will increase YO members' knowledge of mental health resources and decrease stigma associated with seeking mental health services. Second, the investigators will see an increase in YO members' receipt of needed mental health services. Third, the investigators will see improvement in YO members' mental health. Fourth, as a result of their improved mental health, YO members will more actively engage in YO program activities and achieve more key program milestones (e.g., GED completion). These objectives are sequential, with later objectives predicated on the achievement of earlier ones.
- Conditions
- Depression
- Being tested
- Comprehensive Mental Health Services and Supports
- Keywords
- Depressive symptoms, Mental health services, Adolescents, Young adults, African-American
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Mental Health Services and SupportsBehavioural
This study uses a quasi-experimental design to test the efficacy of a comprehensive mental health intervention to improve the mental health and employment outcomes of young adults (18-24) enrolling in the Eastside YO Program. Newly enrolling Eastside YO members will receive an array of mental health education and services based on level of need and serve as this study's intervention group. Newly enrolling Westside YO members will receive "usual care" services delivered by the staff at the Westside YO Program and serve as this study's comparison group.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Mental Health Services | Experimental | Intervention group participants will receive an array of mental health education and services based on their level of need. Study participants will fall into low, moderate, or elevated risk based on results of baseline screening. Services will be provided to each group as specified below. Low risk group: (a) Initial meeting with one of the licensed clinical social workers (LCSW-C), (b) education activities to promote knowledge and change attitudes around mental health; Moderate risk group: (a) Initial meeting with one of the licensed clinical social workers (LCSW-C), (b) Short-term mental health services delivered by the LCSW-C, (c) Depression prevention intervention, (d) Education activities to promote knowledge and change attitudes around mental health; High risk group: (a) Initial meeting with one of the licensed clinical social workers (LCSW-C), (b) Mental health treatment services, (c) Education activities to promote knowledge and change attitudes around mental health. Receives: Behavioral: Comprehensive Mental Health Services and Supports |
| Usual Care (Employment Training Services) | Active comparator | Newly enrolling Westside YO members will receive "usual care" services, which constitute a moderate level of mental health services and supports. The usual care services related to mental health at the Westside will include (1) the ACASI screen for all newly enrolling Westside YO members, (2) the initial visit with a LCSW-C, and (3) mental health training for Westside Case Advocates. More extensive mental health educational activities and services (e.g., additional sessions with LCSW-C, SOS Club) provided to the intervention group will not be available at the Westside YO Center during the initial study period. Also, Eastside Case Advocates will receive more extensive and ongoing mental health training. Receives: Behavioral: Comprehensive Mental Health Services and Supports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Measured: November 2008-November 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2009 (estimated)
- Study startNov 2008
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 1
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 782 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00979524
- Sponsor's protocol ID
- U48DP001919-01
- Status last verified
- Apr 2016
- First submitted
- 17 Sep 2009
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Mental Health in African American Job Training Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT00979524
- Acronym / sponsor ID
- U48DP001919-01
- Conditions
- Depression
- Keywords
- Depressive symptoms, Mental health services, Adolescents, Young adults, African-American
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 782 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Sep 2009 (estimated)
- 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 project's focus is twofold-to change the culture of an employment training program for adolescents and young adults (Youth Opportunities, or "YO") to more fully address the many mental health issues faced by its participants and to expand and improve the quantity and quality of mental health services for YO members. Four project components have been carefully selected to address the mental health issues of YO members: (1) Mental health education/training for YO staff and peer leaders, (2) Mental health education activities for YO members, (3) mental health screening on all newly enrolling YO members, and (4) comprehensive mental health services for YO members. These project components will be implemented at the HEBCAC YO Program (subsequently referred to as "Eastside" YO), with the Westside YO Program initially participating as a control site. Researchers at the Johns Hopkins University Center for Adolescent Health, led by Dr. Darius Tandon of the Department of Pediatrics, will conduct the research examining the effectiveness of these mental health services and supports.
There are four project objectives. First, the proposed activities will increase YO members' knowledge of mental health resources and decrease stigma associated with seeking mental health services. Second, the investigators will see an increase in YO members' receipt of needed mental health services. Third, the investigators will see improvement in YO members' mental health. Fourth, as a result of their improved mental health, YO members will more actively engage in YO program activities and achieve more key program milestones (e.g., GED completion). These objectives are sequential, with later objectives predicated on the achievement of earlier ones.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Mental Health Services | Experimental | Behavioral: Comprehensive Mental Health Services and SupportsIntervention group participants will receive an array of mental health education and services based on their level of need. Study participants will fall into low, moderate, or elevated risk based on results of baseline screening. Services will be provided to each group as specified below. Low risk group: (a) Initial meeting with one of the licensed clinical social workers (LCSW-C), (b) education activities to promote knowledge and change attitudes around mental health; Moderate risk group: (a) Initial meeting with one of the licensed clinical social workers (LCSW-C), (b) Short-term mental health services delivered by the LCSW-C, (c) Depression prevention intervention, (d) Education activities to promote knowledge and change attitudes around mental health; High risk group: (a) Initial meeting with one of the licensed clinical social workers (LCSW-C), (b) Mental health treatment services, (c) Education activities to promote knowledge and change attitudes around mental health. |
| Usual Care (Employment Training Services) | Active comparator | Behavioral: Comprehensive Mental Health Services and SupportsNewly enrolling Westside YO members will receive "usual care" services, which constitute a moderate level of mental health services and supports. The usual care services related to mental health at the Westside will include (1) the ACASI screen for all newly enrolling Westside YO members, (2) the initial visit with a LCSW-C, and (3) mental health training for Westside Case Advocates. More extensive mental health educational activities and services (e.g., additional sessions with LCSW-C, SOS Club) provided to the intervention group will not be available at the Westside YO Center during the initial study period. Also, Eastside Case Advocates will receive more extensive and ongoing mental health training. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All newly enrolling Eastside and Westside YO members during the study period will be eligible for study participation.
Key exclusion criteria (1 listed)
- We will not enroll YO members currently in foster care in this study.
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 |
|---|---|---|
| Comprehensive Mental Health Services and SupportsThis study uses a quasi-experimental design to test the efficacy of a comprehensive mental health intervention to improve the mental health and employment outcomes of young adults (18-24) enrolling in the Eastside YO Program. Newly enrolling Eastside YO members will receive an array of mental health education and services based on level of need and serve as this study's intervention group. Newly enrolling Westside YO members will receive "usual care" services delivered by the staff at the Westside YO Program and serve as this study's comparison group. | Behavioural | Comprehensive Mental Health Services, Usual Care (Employment Training Services) |
Primary outcome
Depressive symptoms
Time frame: November 2008-November 2012
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 7 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comprehensive Mental Health Services and Supports in people with Depression, run by Johns Hopkins University at 1 site in United States.
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 1 inclusion and 1 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 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Depressive symptoms (time frame: November 2008-November 2012). 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 7 Apr 2016.