NCT03409991

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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 24, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

October 22, 2021

Status Verified

September 1, 2021

Enrollment Period

6 years

First QC Date

January 18, 2018

Last Update Submit

October 14, 2021

Conditions

Keywords

Psychiatric RehabilitationCareer Counseling

Outcome Measures

Primary Outcomes (7)

  • Employment and Vocational Activities Checklist

    Participants will report greater engagement in vocational activities. Employment and Vocational Activities Checklist, a brief instrument used in prior Center studies that inquires about current pre-employment and vocational activities, including for example, career development activities and independent job searches

    12 months

  • Work Hope Scale (Juntunen & Wettersten, 2006)

    24-item 7-point Likert-type scale that measures the construct of work hope, and includes: Work Goals, Agency, and Pathways. The scale is a stable and well-validated measure with reported internal consistency of the overall scale of .93 and .87, .68 and .81 for the sub-scales

    12 months

  • Goal Attainment Scale (GAS, Kiresuk, et al, 1968)

    Goal Attainment Scale provides a structured approach to determining goal achievement regardless of the type or uniqueness of goal (Kiresuk \& Sherman, 1968). Recent reviews of GAS confirms that it can be useful in measuring rehabilitation goals, is reliable and sensitive to change (Marson, et al., 2009; Hurn, et al., 2006, Turner-Stokes, 2009)

    12 months

  • Career Adapt-Abilities Scale (CAAS; Savickas & Porfeli, 2012)

    Career Adapt-Abilities Scale (CAAS; Savickas \& Porfeli, 2012) measures an individual's psychosocial readiness and resources for coping with current and imminent vocational development tasks, occupational transitions, and work traumas using four scales which measure concern, control, curiosity, and confidence. Internal consistency estimates for the subscale and total scores ranged from good to excellent i.e. .82 to .88. Concurrent validity evidence was found to be strong between the subscales of CAAS and the Vocational Identity Status Assessment (VISA; Porfeli, Lee, Vondracek, \& Weigold, 2011)

    12 months

  • Career Thoughts Inventory (CTI; Sampson et al., 1996)

    The CTI consists of 48 Likert-scale items rated on a 4-point agree scale representing typical dysfunctional/negative career thoughts including Decision-Making Confusion, Commitment Anxiety, and External Conflict. The CTI developers report alpha coefficients for the total score ranging from .93 to .97; and for the subscales ranged from .74 to .94. The authors also provide support for the CTI's construct validity, convergent validity, and criterion validity.

    12 months

  • Behavior and Symptom Identification Scale (BASIS - 24) (Eisen, et al., 2004, Eisen et al., 2006)

    The BASIS-24 is designed to measure mood disturbances, anxiety, interpersonal and role functioning, daily living skills, psychotic symptoms, impulsivity and substance use using a 5-point Likert-type scale. Extensive and excellent reliability and validity data exists for the instrument from a national study involving over 5,000 participants (Eisen, et al., 2004; Eisen, et al., 2006)

    12 months

  • Brief Quality of Life Scale, Subjective Items (Lehman Quality of Life Scale, Brief Version, Lehman, 1988)

    Brief Quality of Life Scale, Subjective Items (Lehman Quality of Life Scale, Brief Version, Lehman, 1988) measures both objective and subjective quality of life across multiple domains including living situation, family relations, social relations, work, and the like. It has considerable psychometric data suggesting adequate validity and reliability (Lehman, 1995; Russo et al., 1997). We will employ 2 items from this scale: the subjective measures of life in general and work satisfaction.

    12 months

Study Arms (2)

Experimental

EXPERIMENTAL

Receives the 12-week Opening Doors group sessions, and up to 8 individual career counseling sessions.

Behavioral: Opening Doors

Waitlist Control

NO INTERVENTION

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.

Interventions

Opening DoorsBEHAVIORAL

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.

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • are 18 years or older;
  • 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.;
  • express an interest in exploring their career options;
  • are unemployed or engaged in part-time employment;
  • express an interest in working in the future;
  • have basic knowledge of using computers; and,
  • are willing and able to attend a 1-2 hour orientation session at the Recovery Center.

You may not qualify if:

  • are unable to give full and knowing consent;
  • are unable to participate in data collection;
  • are actively receiving vocational counseling; and, 4) have full-time paid employment;
  • \) have a legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Center for Psychiatric Rehabilitation

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Erna S. Rogers, Sc.D.

    Boston University Center for Psychiatric Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 25, 2018

Study Start

September 24, 2015

Primary Completion

September 14, 2021

Study Completion

September 14, 2021

Last Updated

October 22, 2021

Record last verified: 2021-09

Locations