Enhancing Cognitive and Work/School Outcomes in First Episode Psychosis Using Cognitive Self-Management Strategies

The Coordinated Specialty Care (CSC) programs in the EPINET-TX Network provide Supported Employment and Education (SEE) services for young adults between the ages of 15-32 experiencing first episode psychosis (FEP). In this pilot cluster randomized clinical trial (RCT), six CSC programs representing different geographical regions including the urban southwest (serving a majority Latino population), the urban central and southeast (serving majority African American population), and the rural north and northeast (serving a racially/ethnically mixed population) that are part of the EPINET-TX Network will be recruited. Once the 6 SEE teams have been recruited, they will be randomized using a stratified procedure based on geographic region and populations served.

The 3 SEE teams randomized to the experimental group will be trained in CSM by the Boston University (BU) research team. During the training period, the CSC team program director and SEE specialist will be trained in CSM resources and methods, beginning with an online self-paced training course, followed by weekly and then biweekly zoom-based group supervision with BU researchers. CSM sessions will be audio-recorded as part of initial training and ongoing fidelity checks. Zoom meeting training sessions will also be recorded. CSM training is expected to take approximately three months, and the participating SEE programs will be reimbursed for staff training time. Designated site CSC personnel from both the experimental and the control group sites will be trained to administer the outcome assessments.

After training of CSC teams and assessors is complete, recruitment of young adults with FEP will begin at all 6 sites simultaneously. Recruitment of young adult participants will include information meetings conducted by the program directors of participating CSC programs, consent and assent meetings, and the baseline assessment. Once identified, these program directors will be added as staff on the Institutional Review Board (IRB).

The 6 CSC teams will then administer either the experimental intervention (CSM + SEE) intervention or the control intervention (SEE only). Staff within the experimental group will continue to receive support from the BU PI's, who will periodically administer the CSM Fidelity Scale to ensure CSM intervention fidelity.

Young adult participants in both the experimental and control groups will complete assessments at baseline, 6 months, 12 months, and 18 months. These assessments will take place in person by a trained onsite assessor. The baseline assessment battery will include a demographics questionnaire, history of employment and education questionnaire, the WRAT to assess reading level, and 2 cognitive assessments (described below). Follow-up assessments will only include the cognitive measures. These assessments are expected to take between 60-90 minutes for a total of 6 hours of time.

In addition, research sites will share the results of the Core Assessment Battery (CAB), an assessment that is administered as a part of routine CSC care every six months, with the BU researchers every 6 months. Additional information about prescribed medication, SEE program utilization, and psychiatric hospitalizations is normally collected quarterly and will be shared at each assessment. Education and employment logs will be collected weekly and shared with the BU research team. This information will be collected on all young adult participants.

Young adults with FEP in the experimental group will participate in the CSM intervention. The teaching of Cognitive Self-Management Strategies (CSM) by SEE specialists includes an additional 12 sessions that range from 45 to 60 minutes long. Thus, participants in the experimental group will complete about 18 hours of study activities over an 18-month period. Those in the control group will participate in the assessments, about 6 hours of study activities over an 18-month period.

After the study is over, participants from the control group still enrolled in the CSC program will be offered CSM if appropriate to their goals.

• The Clinical Outcomes in Measurement-based care Assessment of Symptoms and Severity (COMPASS-10) [Срок оценки: baseline, 6-, 12-,18-months]
• The Global Functioning Social and Role Subscales [Срок оценки: Baseline, 6-, 12-, 18-months]
• The Personal Wellbeing Index [Срок оценки: Baseline, 6-, 12-, and 18- months]
• The Alcohol Use Scale [Срок оценки: Baseline, 6-, 12-, and 18-months]
• The Drug Use Scale [Срок оценки: Baseline, 6-, 12-, and 18-months]
• Substance Use Abuse Treatment Stage [Срок оценки: Baseline, 6-, 12-, and 18-months]