About this trial
The goal of this pilot cluster randomized trial is to understand if adding a standardized cognitive self-management program, Thinking Skills for Work-Cognitive Self-Management Strategies (CSM) to Coordinated Specialty Care Supported Employment and Education (SEE) programs improves the work and school outcomes of young adults experiencing first episode psychosis. The main questions it aims to answer are:
* Does adding the CSM program to usual SEE services lead to improved work and school outcomes, such as ability to find a job or enroll in school, or ability to keep a job or stay in school? * Does adding the CSM program to usual SEE services improve cognition and cognitive self-efficacy? Researchers will recruit six research sites and these will be randomized to either treatment as usual, where they will offer regular SEE services, or the experimental groups, where they will offer regular SEE services plus the CSM program.
Participants in both groups will be asked to complete a brief assessment at baseline, 6-months, 12-months, and 18-months. Participants in the experimental group will be asked to participate in the 12-session CSM program in addition to their regular SEE services.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
currently in their first 18 months of enrollment in the CSC program
at least 15 years of age
receiving SEE services but not employed or enrolled in school
have the desire to work or resume school.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Thinking Skills for Work-Cognitive Self-Management Program (CSM)
BehavioralCSM is a 12-session program that promotes the development of specific cognitive strategies to promote success in employment and education outcomes. This is a standardized, evidence-based intervention with adults with serious mental illness. Each session is facilitated by a trained cognitive specialist and lasts between 45- 60 minutes. Session topics include self-assessment of cognitive skills, recognizing strengths, challenging negative thoughts, attention and concentration, memory, organization, planning, and thinking ahead.
Treatment as Usual (TAU)
BehavioralIn this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.
Treatment groups
Trial outcomes
Primary outcomes
School and Education Activity Tracker
This qualitative measure tracks the participant's participation in education or employment activities on a weekly basis. It includes questions about the education or employment activity and the time spent completing the activity. The minimal value is 0, there is no maximum value.
The Cognitive Problems and Strategies Assessment
Standardized measure that assesses cognitive functioning and strategy use. It includes two subscales, the "Cognitive Problems Subscale" and the "Strategy Use Subscale", each consisting of 30 items that are scored from 0-3 (cumulative 0-90). A higher score on the Cognitive Problems Subscale indicates a worse outcome, whereas higher scores on the Strategy Use Subscale indicate better outcomes.
Cognitive Self-Efficacy Scale
Standardized measure that assesses an individual's confidence in everyday cognitive tasks. This is a 10 item scale with values ranging from 0 to 100, with higher values indicating better outcomes.
Secondary outcomes
The Clinical Outcomes in Measurement-based care Assessment of Symptoms and Severity (COMPASS-10)
This 10-item clinician-rated instrument evaluates positive, negative, and affective symptom severity for individuals experiencing early-phase or first-episode psychotic disorders. Rated on a scale from 0 (not present) to 6 (very severe). Lower values indicate treatment progress in this study.
The Global Functioning Social and Role Subscales
This 2 item scale measure was designed for young adults and measures a participant's social connections and daily responsibilities. This clinician-rated scale is scored from 1 to 10, where higher numbers indicate better outcomes.
The Personal Wellbeing Index
This is a self-report, 8-item scale, that measures life satisfaction across standard of living, personal health, and relationships. Scores range from 0 (low-wellbeing) to 10 (high-wellbeing). Higher scores indicate better outcomes in this study.
The Alcohol Use Scale
This study uses 1 item from this scale, "Please rate your worst 1 month over the past 6 months." Participants report the following ratings: 1. Abstinent 2. Use with Impairment 3. Mild Alcohol Use 4. Moderate Alcohol Use 5. Severe Alcohol Use Lower scores indicate better outcomes.
Other outcomes
Demographics Form
Standardized set of questions about a participants age, gender, race/ethnicity, gender, and diagnosis
History of employment and education
Standardized set of questions about an individual's past employment and education activities
Sponsors and contacts
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Boston University Charles River Campus
Lead sponsor
University of Texas
Collaborator