Clinical trial NCT03409991: Testing the Efficacy of Opening Doors: A Career Guidance Intervention for Individuals With Psychiatric Disabilities
Official title: Testing the Efficacy of Opening Doors: A Career Guidance Intervention for Individuals With Psychiatric Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Disorder
Keywords: Psychiatric Rehabilitation
Career Counseling
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2018-01-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This project is designed to develop and test a career guidance intervention called Opening Doors (OD) expected to assist individuals with psychiatric disabilities acquire knowledge, skills, and attitudes needed to pursue and advance in their careers. This project is a three-stage mixed methods study to 1) refine and pilot-test the Opening Doors career guidance intervention, 2) conduct a randomized control trial (RCT) to test the efficacy of the intervention with a waitlist control group, and 3) conduct a qualitative and process sub-study of the critical ingredients of the OD intervention from the perspective of participants. This study takes place at the Boston University Center for Psychiatric Rehabilitation (CPR). It is hypothesized that when compared to control group participants, individuals receiving Opening Doors will report 1) higher levels of vocational and pre-vocational activities, 2) greater career adaptability, fewer dysfunctional and more functional career thoughts, 3) greater work hope when compared to the waitlist control group participants, 4) greater vocational goal attainment, and 5) improved symptoms and functioning.

Detailed description: This project is designed as a three-stage mixed methods study to test the efficacy of a career guidance intervention called Opening Doors to improve the employability and employment trajectory of individuals with psychiatric disabilities.

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.

Eligibility criteria: Inclusion Criteria:

1. are 18 years or older;
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:

1. are unable to give full and knowing consent;
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.

Primary outcomes:
measure: Employment and Vocational Activities Checklist
timeFrame: 12 months
measure: Work Hope Scale (Juntunen & Wettersten, 2006)
timeFrame: 12 months
measure: Goal Attainment Scale (GAS, Kiresuk, et al, 1968)
timeFrame: 12 months
measure: Career Adapt-Abilities Scale (CAAS; Savickas & Porfeli, 2012)
timeFrame: 12 months
measure: Career Thoughts Inventory (CTI; Sampson et al., 1996)
timeFrame: 12 months
measure: Behavior and Symptom Identification Scale (BASIS - 24) (Eisen, et al., 2004, Eisen et al., 2006)
timeFrame: 12 months
measure: Brief Quality of Life Scale, Subjective Items (Lehman Quality of Life Scale, Brief Version, Lehman, 1988)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Center for Psychiatric Rehabilitation
state: Massachusetts
Study officials:
affiliation: Boston University Center for Psychiatric Rehabilitation
name: Erna S. Rogers, Sc.D.
role: PRINCIPAL_INVESTIGATOR
References: