NCT03118388

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2011

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

April 6, 2017

Last Update Submit

April 13, 2017

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    20 months

Study Arms (2)

36 SEI youth

EXPERIMENTAL

36 homeless youth (ages 16-24) randomized to the SEI intervention

Behavioral: Social Enterprise Intervention

36 IPS youth

EXPERIMENTAL

36 homeless youth (ages 16-24) randomized to the IPS intervention

Behavioral: IPS

Interventions

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).

Also known as: SEI, social enterprise
36 SEI youth
IPSBEHAVIORAL

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.

Also known as: Individual Placement and Support, supported employment
36 IPS youth

Eligibility Criteria

Age16 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Interventions

Palliative CareEmployment, Supported

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesEmploymentSocioeconomic FactorsPopulation CharacteristicsRehabilitation, VocationalRehabilitation

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 18, 2017

Study Start

September 18, 2009

Primary Completion

August 31, 2011

Study Completion

August 31, 2011

Last Updated

April 18, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share