Testing the Efficacy of Opening Doors: A Career Guidance Intervention for Individuals With Psychiatric Disabilities
NCT ID: NCT03409991
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2015-09-24
2021-09-14
Brief Summary
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Detailed Description
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Stage 1 involved a pilot-test of the Opening Doors (OD) career guidance intervention to conduct a feasibility test. In Stage 2 the investigators are conducting a randomized control trial (RCT) to test the efficacy of the intervention. Stage 3, which is a qualitative and process sub-study to understand the value of the OD intervention from the perspective of participants, is being conducted simultaneously with Stage 2 The Opening Doors Intervention: The Opening Doors intervention is a new career guidance intervention for individuals with psychiatric disabilities that uses traditional career guidance resources, progressive employment principles and mainstream Internet-based resources, delivered in the context of providing tailored supports for participants' with mental illness. Opening Doors is designed as an approximately 12- week group and individual career guidance intervention. The curriculum is delivered by trained career counselors in small groups over about 20 sessions of 90 minutes each with the addition of up to 8 weekly 1 hour individual sessions. Opening Doors also has optional on-going drop-in hours available for participants of the program (current and past) to improve their job application potential on an on-going basis. Opening Doors includes considerable peer involvement i.e. the consultation and inclusion of individuals with lived experience of psychiatric disabilities in the development and delivery of the intervention.
Method: The Opening Doors intervention has been pilot-tested using a simple pretest-posttest design in order to assess feasibility of the intervention and research procedures. The investigators are currently using a randomized clinical trial design (RCT) to test the effectiveness of the Opening Doors intervention. Up to 108 participants are expected to participate in the intervention. Baseline assessments are completed and random assignment to experimental or control conditions are performed, stratifying for gender and minority status using a computer generated randomization plan. Assessments are conducted at baseline, 3, 6, 9 and 12 months post-baseline for both experimental and control groups. Control participants are placed on a waitlist and offered participation at a later date i.e. 12 months after the baseline assessment. The investigators use qualitative methods for a sub-study and process evaluation. Twelve participants (2 per wave) who have completed at least 12 sessions of the OD will be invited to participate in one-hour qualitative interviews to obtain their perspectives on the intervention. Each participant participates in a one hour single-session audio-taped interview by research staff. Data from the qualitative interviews is collected using an interview guide and participants are probed for perceived benefits of the intervention and hypothesized helpful mechanisms of OD. The investigators also query the staff about their perceptions of the barriers and facilitators to delivering OD. Additional process information described above in "process data" is collected on all study participants.
Data Analysis: Depending on the level of measurement, analysis of variance, t-tests, or chi-square tests were conducted to determine baseline equivalency between Experimental and Control groups. All hypotheses were tested using mixed modeling analyses, adjusting for baseline values and examining effects for time, group, and the group-by-time interactions. We found no differences between the experimental and control groups using an ITT approach or adjusting for intervention intensity. We conducted responder analyses to further explore what worked and for whom.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Experimental
Receives the 12-week Opening Doors group sessions, and up to 8 individual career counseling sessions.
Opening Doors
This project is designed as a three-stage mixed methods study to test the efficacy of a career guidance intervention for individuals with psychiatric disabilities. We are using both a randomized clinical trial design coupled with a small qualitative sub-study.
Waitlist Control
Offered non-vocational classes at the Boston University Center for Psychiatric Rehabilitation, and offered the chance to attend the Opening Doors program at the end of their enrolled 12-month study period.
No interventions assigned to this group
Interventions
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Opening Doors
This project is designed as a three-stage mixed methods study to test the efficacy of a career guidance intervention for individuals with psychiatric disabilities. We are using both a randomized clinical trial design coupled with a small qualitative sub-study.
Eligibility Criteria
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Inclusion Criteria
2. have a psychiatric disability as evidenced by a) the presence of a psychiatric diagnosis, b) the interference of psychiatric symptoms with important areas of life functioning such as, work or school, and c) current or past use of psychiatric services such as, medications, hospitalizations, psychotherapy, etc.;
3. express an interest in exploring their career options;
4. are unemployed or engaged in part-time employment;
5. express an interest in working in the future;
6. have basic knowledge of using computers; and,
7. are willing and able to attend a 1-2 hour orientation session at the Recovery Center.
Exclusion Criteria
2. are unable to participate in data collection;
3. are actively receiving vocational counseling; and, 4) have full-time paid employment;
5\) have a legal guardian.
18 Years
ALL
No
Sponsors
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National Institute on Disability, Independent Living, and Rehabilitation Research
FED
Boston University Charles River Campus
OTHER
Responsible Party
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Erna Sally Rogers
Principal Investigator
Principal Investigators
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Erna S. Rogers, Sc.D.
Role: PRINCIPAL_INVESTIGATOR
Boston University Center for Psychiatric Rehabilitation
Locations
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Boston University Center for Psychiatric Rehabilitation
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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3727
Identifier Type: -
Identifier Source: org_study_id