NCT07749105 · Boston University Charles River Campus
Enhancing Cognitive and Work/School Outcomes in First Episode Psychosis Using Cognitive Self-Management Strategies
What this study is about
The goal of this pilot cluster randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Thinking Skills for Work-Cognitive Self-Management Program (CSM)
CSM 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.
BEHAVIORAL
Treatment as Usual (TAU)
In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.
Primary outcome measures
School and Education Activity Tracker
Time frame: Tracked weekly through study completion (about 18 months)
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
Time frame: Baseline, 6-, 12-, and 18-months
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
Time frame: Baseline, 6-, 12-, and 18-months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 1\) Young adults who are not fluent in english
Where
- Big Spring, Texas
- Granbury, Texas
- Laredo, Texas
- Longview, Texas
Collaborators
University of Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 6, 2026 · Source of record for eligibility and locations