Recruiting

CSM with SEE

Sponsor:

Boston University Charles River Campus

Code:

NCT07749105

Conditions

First Episode Psychosis (FEP)

Eligibility Criteria

Sex: All

Age: 15 - 32

Healthy Volunteers: Not accepted

Interventions

Thinking Skills for Work-Cognitive Self-Management Program (CSM)

Treatment as Usual (TAU)

Study Details

Brief summary:

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.

Conditions

First Episode Psychosis (FEP)

Study ID

NCT07749105

Start date

Aug 10, 2025

Status verified date

Aug, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 32

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. currently in their first 18 months of enrollment in the CSC program
2. at least 15 years of age
3. receiving SEE services but not employed or enrolled in school
4. have the desire to work or resume school.

Exclusion Criteria:

1\) Young adults who are not fluent in english

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CSM plus SEE Group

The 3 sites (30 participants) from this site will receive the standardized 12 session CSM program in addition to regular SEE services. The CSM sessions will occur weekly and last between 45-60 minutes. They cover 12 different areas of cognition such as self-assessment, recognizing strengths, challenging negative thinking, attention and concentration, memory organization, planning ahead, problem-solving, and thinking speed.

active comparator: Treatment as Usual

In this arm, the 3 sites (30 participants) will participate in regular weekly SEE services.

Interventions

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.

Treatment as Usual (TAU)

In this intervention, participants receive regular weekly Supported Education and Employment (SEE) services.

Primary outcome measure

  • School and Education Activity Tracker [ Time Frame: Tracked weekly through study completion (about 18 months) ]
  • The Cognitive Problems and Strategies Assessment [ Time Frame: Baseline, 6-, 12-, and 18-months ]
  • Cognitive Self-Efficacy Scale [ Time Frame: Baseline, 6-, 12-, and 18-months ]

Central Contacts and Locations

Central contacts

Susan R McGurk, PhD

617-353-3549mcgurk@bu.edu

Alexa Trolley-Hanson, MS

617-353-3549athanson@bu.edu

Locations

West Texas Centers Promoting Behavioral and Developmental Health

Recruiting

Big Spring, Texas, United States, 79720

Contacts

Monique Gusman

1-800-852-2193monique.gusman@wtcmhmr.org

Principal Investigator:

Amanda Ryan, PhD

Pecan Valley Centers for Behavioral and Developmental Healthcare

Recruiting

Granbury, Texas, United States, 76048

Contacts

David Risner

817-579-4400drisner@pecanvalley.org

Amanda Ryan, PhD

amanda.ryan@austin.utexas.edu

Principal Investigator:

Molly Lopez, PhD

Border Region Behavioral Health Care

Recruiting

Laredo, Texas, United States, 78041

Contacts

Janie Hernandez

956-794-3178sanjuanah@borderregion.org

Amanda Ryan, PhD

amanda.ryan@austin.utexas.edu

Principal Investigator:

Molly Lopez, PhD

More Information

Sponsor

Boston University Charles River Campus

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Young adults
  • First Episode Psychosis
  • Supported Employment and Education
  • Cognitive remediation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Boston University Charles River Campus on 2026-08-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.