Mental DisorderPhase 2SEINCT03118388
Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs
A Phase 2 study testing Social Enterprise Intervention and IPS in people with Mental Disorder and Mental Health, run by Arizona State University.
Trial summary
This randomized controlled trial (RCT) compared the efficacy between the Social Enterprise Intervention (SEI) and Individual Placement and Support (IPS) with homeless youth with mental illness. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, Mental Health, Employment
- What is being tested?
- Social Enterprise Intervention and IPS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2009to 31 Aug 2011
- Phase
- Phase 2
- 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
- Age 16-24
- English speaking
- Primary clinical diagnosis in the past year (with at least one symptom in the past 4 weeks) using the DISC-Y interview for one of six mental illnesses (i.e., Major Depressive Episode, Mania/ Hypomania, Generalized Anxiety, Post-traumatic Stress Disorder, Conduct Disorder, and Alcohol/Substance Use Disorders
- Desire to work.
Who cannot join
- None
About this study
This randomized controlled trial (RCT) compared the efficacy between the Social Enterprise Intervention (SEI) and Individual Placement and Support (IPS) with homeless youth with mental illness.
Methods: Non-probability quota sampling sampling was used to recruit 72 homeless youth from one agency, who were randomized to the SEI (n=36) or IPS (n=36) conditions.
Read the detailed description
In response to the limited use of RCTs with homeless youth to test research-supported interventions, this study compares the efficacy and short-term outcomes of two interventions that combine employment and clinical services with homeless youth experiencing mental illness. The Social Enterprise Intervention (SEI) is a research-supported intervention using a group approach that engages homeless youth in paid employment as well as case-management and mental health services through involvement in an agency-run social enterprise. The Individual Placement and Support (IPS) model of supported employment is an individually focused, evidence-based intervention , which provides individuals with severe mental illness with customized, long-term, and integrated vocational, case-management, and clinical services to help them gain and maintain competitive employment.
A randomized comparative efficacy trial of the short-term, nonvocational outcomes (depression, self-esteem, social support, housing stability) of the SEI and IPS was conducted over 20 months with 72 homeless youth at a homeless youth drop-in center in Los Angeles. This study answered two research questions: 1) Do homeless youth with mental illness participating in an employment intervention integrated with clinical services (SEI or IPS) experience improvements in their a) mental health status (self-esteem and depression); b) housing stability, and c) social support; and 2) What are the differences between the SEI and IPS groups on mental health, housing stability, and social support outcomes between baseline and follow-up?
- Conditions
- Mental Disorder, Mental Health, Employment, Housing Problems, Social Support
- Being tested
- Social Enterprise Intervention, IPS
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Enterprise InterventionBehavioural
Also called SEI, social enterprise
The SEI model was implemented in four stages: 1) Vocational skill acquisition (4 months); 2) Small business skill acquisition (4 months); 3) SEI formation and product distribution (12 months); and 4) Clinical/case-management services, (ongoing for 20 months).
IPSBehavioural
Also called Individual Placement and Support, supported employment
To implement the IPS at the host agency, one employment specialist, two case managers, and two clinicians were assigned the 22 available IPS cases among them at baseline. Over the 20 months, all IPS participants met individually with the employment specialist, one case manager, and one clinician at least weekly. Regarding job development in the community, the IPS employment specialist also spent about 40% of each week out in the community building relationships with new and existing employers.
| Study group | Role | What they receive |
|---|---|---|
| 36 SEI youth | Experimental | 36 homeless youth (ages 16-24) randomized to the SEI intervention Receives: Behavioral: Social Enterprise Intervention |
| 36 IPS youth | Experimental | 36 homeless youth (ages 16-24) randomized to the IPS intervention Receives: Behavioral: IPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression between baseline and follow-up (using the Adult Self-Report)
Depression was assessed using the Adult Self-Report (ASR) DSM-Oriented Scale for Depressive Problems, consisting of 14 items that measure related emotions and behaviors (Achenbach, 1997). Scoring profiles used normed scales for adults ages 18-35. Higher scores reflected a higher presence of emotions and behaviors. For men, raw scores between 10 and 12 (11 and 13 for women) were within the borderline clinical range, whereas scores 13 and greater (14 and greater for women) were considered in the clinical range.
Measured: 20 months
Change in social support between baseline and follow-up (using the Adult Self-Report)
Social support was a composite-score variable of the sum of four items on the ASR Friends Subscale. The response categories for each item range from none to 5 or more for questions including: "About how many close friends do you have?" The range of scores is from 0 to 12, with higher scores indicating greater social support for the youth.
Measured: 20 months
Change in housing stability status between baseline and follow-up (using a 3-item self-report measure of housing status)
Youth were asked at 20 months about their housing status (i.e., whether they had lived on the streets, in a shelter or institution [i.e., youth or adult shelter, or detention facility, jail, or prison], or in a private residence with family [i.e., biological or foster], relatives, friends, a partner, roommate or alone). Each item was dichotomous and scored as 0 = no or 1 = yes.
Measured: 20 months
Change in self-esteem between baseline and follow-up (using the Rosenberg Self-Esteem Scale)
Self-esteem was measured using the Rosenberg Self-Esteem Scale (RSE; Rosenberg, 1979), a 10-question assessment of feelings about self-worth. Each item is rated using a 4-point Likert-type scale ranging from strongly disagree to strongly agree. Five items are recoded so that higher scores indicate higher levels of self-esteem. The possible range of RSE raw scores is 0 to 30. Scores between 15 and 25 are within normal range, whereas scores below 15 suggest low self-esteem.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start18 Sep 2009
- Primary completion31 Aug 2011
- Study completion31 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by Arizona State 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The SEI model was implemented in four stages: 1) Vocational skill acquisition (4 months); 2) Small business skill acquisition (4 months); 3) SEI formation and product distribution (12 months); and 4) Clinical/case-management services, (ongoing for 20 months). The eight IPS principles were implemented over 20 months by an employment specialist, clinician, and case manager.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, Kristin Ferguson-Colvin, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118388
- Sponsor's protocol ID
- 1R34MH082804-01A2
- Acronym
- SEI
- Status last verified
- Apr 2017
- First submitted
- 6 Apr 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs
- ClinicalTrials.gov ID
- NCT03118388
- Acronym / sponsor ID
- SEI / 1R34MH082804-01A2
- Conditions
- Mental Disorder, Mental Health, Employment, Housing Problems, Social Support
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 18 Sep 2009 (actual)
- Primary completion
- 31 Aug 2011 (actual)
- Study completion
- 31 Aug 2011 (actual)
- First posted
- 18 Apr 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 randomized controlled trial (RCT) compared the efficacy between the Social Enterprise Intervention (SEI) and Individual Placement and Support (IPS) with homeless youth with mental illness.
Methods: Non-probability quota sampling sampling was used to recruit 72 homeless youth from one agency, who were randomized to the SEI (n=36) or IPS (n=36) conditions.
Detailed description
In response to the limited use of RCTs with homeless youth to test research-supported interventions, this study compares the efficacy and short-term outcomes of two interventions that combine employment and clinical services with homeless youth experiencing mental illness. The Social Enterprise Intervention (SEI) is a research-supported intervention using a group approach that engages homeless youth in paid employment as well as case-management and mental health services through involvement in an agency-run social enterprise. The Individual Placement and Support (IPS) model of supported employment is an individually focused, evidence-based intervention , which provides individuals with severe mental illness with customized, long-term, and integrated vocational, case-management, and clinical services to help them gain and maintain competitive employment.
A randomized comparative efficacy trial of the short-term, nonvocational outcomes (depression, self-esteem, social support, housing stability) of the SEI and IPS was conducted over 20 months with 72 homeless youth at a homeless youth drop-in center in Los Angeles. This study answered two research questions: 1) Do homeless youth with mental illness participating in an employment intervention integrated with clinical services (SEI or IPS) experience improvements in their a) mental health status (self-esteem and depression); b) housing stability, and c) social support; and 2) What are the differences between the SEI and IPS groups on mental health, housing stability, and social support outcomes between baseline and follow-up?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The SEI model was implemented in four stages: 1) Vocational skill acquisition (4 months); 2) Small business skill acquisition (4 months); 3) SEI formation and product distribution (12 months); and 4) Clinical/case-management services, (ongoing for 20 months). The eight IPS principles were implemented over 20 months by an employment specialist, clinician, and case manager.
| Arm | Type | Receives |
|---|---|---|
| 36 SEI youth | Experimental | Behavioral: Social Enterprise Intervention36 homeless youth (ages 16-24) randomized to the SEI intervention |
| 36 IPS youth | Experimental | Behavioral: IPS36 homeless youth (ages 16-24) randomized to the IPS intervention |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 16-24
- English speaking
- Primary clinical diagnosis in the past year (with at least one symptom in the past 4 weeks) using the DISC-Y interview for one of six mental illnesses (i.e., Major Depressive Episode, Mania/ Hypomania, Generalized Anxiety, Post-traumatic Stress Disorder, Conduct Disorder, and Alcohol/Substance Use Disorders
- Desire to work.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Social Enterprise InterventionAlso: SEI, social enterpriseThe SEI model was implemented in four stages: 1) Vocational skill acquisition (4 months); 2) Small business skill acquisition (4 months); 3) SEI formation and product distribution (12 months); and 4) Clinical/case-management services, (ongoing for 20 months). | Behavioural | 36 SEI youth |
| IPSAlso: Individual Placement and Support, supported employmentTo implement the IPS at the host agency, one employment specialist, two case managers, and two clinicians were assigned the 22 available IPS cases among them at baseline. Over the 20 months, all IPS participants met individually with the employment specialist, one case manager, and one clinician at least weekly. Regarding job development in the community, the IPS employment specialist also spent about 40% of each week out in the community building relationships with new and existing employers. | Behavioural | 36 IPS youth |
Primary outcome
Change in depression between baseline and follow-up (using the Adult Self-Report)
Time frame: 20 months
Depression was assessed using the Adult Self-Report (ASR) DSM-Oriented Scale for Depressive Problems, consisting of 14 items that measure related emotions and behaviors (Achenbach, 1997). Scoring profiles used normed scales for adults ages 18-35. Higher scores reflected a higher presence of emotions and behaviors. For men, raw scores between 10 and 12 (11 and 13 for women) were within the borderline clinical range, whereas scores 13 and greater (14 and greater for women) were considered in the clinical range.
Change in social support between baseline and follow-up (using the Adult Self-Report)
Time frame: 20 months
Social support was a composite-score variable of the sum of four items on the ASR Friends Subscale. The response categories for each item range from none to 5 or more for questions including: "About how many close friends do you have?" The range of scores is from 0 to 12, with higher scores indicating greater social support for the youth.
Change in housing stability status between baseline and follow-up (using a 3-item self-report measure of housing status)
Time frame: 20 months
Youth were asked at 20 months about their housing status (i.e., whether they had lived on the streets, in a shelter or institution [i.e., youth or adult shelter, or detention facility, jail, or prison], or in a private residence with family [i.e., biological or foster], relatives, friends, a partner, roommate or alone). Each item was dichotomous and scored as 0 = no or 1 = yes.
Change in self-esteem between baseline and follow-up (using the Rosenberg Self-Esteem Scale)
Time frame: 20 months
Self-esteem was measured using the Rosenberg Self-Esteem Scale (RSE; Rosenberg, 1979), a 10-question assessment of feelings about self-worth. Each item is rated using a 4-point Likert-type scale ranging from strongly disagree to strongly agree. Five items are recoded so that higher scores indicate higher levels of self-esteem. The possible range of RSE raw scores is 0 to 30. Scores between 15 and 25 are within normal range, whereas scores below 15 suggest low self-esteem.
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 18 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Social Enterprise Intervention and IPS in people with Mental Disorder and Mental Health, run by Arizona State University.
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 4 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 18 Apr 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in depression between baseline and follow-up (using the Adult Self-Report) (time frame: 20 months). The study lists 4 primary outcomes in all. 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 18 Apr 2017.