Sacramento Clinical High Risk for Psychosis Stepped-Care Program

NCT06640803 | Recruiting

• 2 other identifiers: 1989082H79SM086150
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 6

Brief Summary

This is a dissemination and implementation study that is evaluating a stepped-care intervention for identifying and treating youths at clinical high-risk for psychosis within multiple community mental health centers.

Conditions

Clinical High Risk for Psychosis; Ultra High Risk for Psychosis

Keywords

psychosis; stepped-care; psychosis screening; community-based care; dissemination and implementation

Outcome Measures

Primary Outcomes (5)

• Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention.

  1\. Duration of enrollment in the stepped-care intervention for young people identified as at clinical high-risk for psychosis through their community health setting.

  2, 3, or 4 years depending on site

• Acceptability: Proportion of enrolled youths who move into each step of stepped-care

  Number of youth enrolled in stepped care at each assessment time point (0-, 6-, 12-, 18-, 24-month).

  2, 3, or 4 years depending on site

• Reach: Universal screening outcomes

  Number of youths who reach each stage of the screening pipeline including: 1. Number of youths screened. 2. Number of screened youths who score positive on the screening measure (Prodromal Questionnaire Brief).

  2, 3, or 4 years

• Reach: Number of community clinicians trained in specialized stepped care

  1. The number of clinicians employed at targeted community mental health agencies who complete training in Cognitive Behavioral Case management (CBCM). 2. The number of these CBCM trained clinicians who enroll in the trial.

  2, 3, or 4 years

• Effectiveness: Number of youth who meet criteria for a clinical high risk for psychosis (CHRp) syndrome at each step of the intervention.

  Number of youth who meet CHRp criteria on the Abbreviated Clinical Structured Interview for DSM-5 Attenuated Psychosis Syndrome (mini SIPS) and reach each stage of the intervention (baseline, 6-, 12-, 18-, 24-months).

  from enrollment to the end of treatment at 2 years

Secondary Outcomes (6)

• Modified Colorado Symptom Index (MCSI)

  Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)

• Global Impression Scale

  Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)

• Global Functioning: Social and Role Scales

  Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)

• Life and Treatment satisfaction

  Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)

• Barriers and Facilitators interviews

  6 months after enrollment and when their final treatment client completes treatment

Study Arms (1)

Cognitive Behavioral Case Management

EXPERIMENTAL

Once youths are identified with a clinical high risk for psychosis (CHRp) syndrome they will begin a 2-year, 6 step intervention. They will be assessed every 6 months. If youths continue to meet CHRp criteria they will move into the next step. If they no longer meet criteria they exit the study and resume standard care. If they develop psychosis or reach the end of the 2-year intervention they can move to EDAPT, a psychosis specialty clinic or work with personnel to find a more appropriate clinical service.

Behavioral: Stepped-Care including Cognitive Behavioral Case Management

Interventions

Stepped-Care including Cognitive Behavioral Case Management BEHAVIORAL

Step 1:assessment and feedback, general engagement strategies, assessment of needs and social determinants of health, begin case management, goal setting. Step 2: TAU. Initiation of team-based care at community clinics and 'enhanced monitoring'. Step 3: atheoretically-based stress management skills (stress thermometer, coping skills and coping plans), problem solving strategies. Step 4: targeted intervention for CHRp. Initiation of formulation-based CBT modules, therapy consultation groups with the UC Davis team (UCD), regular meetings between clinic leadership and UCD. Participants may switch providers to increase level of early psychosis specialization. Step 5: add prescriber consultation groups with UCD. Step 6: assessment of trauma and family conflict then Family-Focused Therapy, Trauma-Focused Cognitive Behavioral Therapy, or CBT for CHR at UCD. Termination: At 24 months, referral to UCD coordinated specialty care clinic or other appropriate service for those still CHRp+.

Also known as: Cognitive Behavioral Therapy for those at clinical high risk for psychosis, team-based stepped-care

Cognitive Behavioral Case Management

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical High Risk for Psychosis Syndrome as assessed by the mini-SIPS
• Aged between 12-25 years old
• Receiving care in one of six identified community mental health clinics
• Eligibility for Sacramento County Medicare
• Ability to provide informed consent

You may not qualify if:

• Intellectual disability (IQ\<70)
• Urgent clinical need for a higher level of care

Sponsors & Collaborators

• University of California, Davis: lead
• Sacramento County Behavioral Health Services: collaborator

Study Sites (6)

River Oak Center for Children

Elk Grove, California, 95758, United States

RECRUITING

Turning Point Community Programs

Elk Grove, California, 95758, United States

RECRUITING

University of California Department of Psychiatry and Behavioral Sciences; Early Psychosis Programs

Sacramento, California, 95817, United States

RECRUITING

University of California-Davis CAARE Diagnostic and Treatment Center

Sacramento, California, 95820, United States

RECRUITING

Capital Star Community Services

Sacramento, California, 95821, United States

RECRUITING

Heartland Child and Family Services

Sacramento, California, 95838, United States

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Daniel I Shapiro, PhD

CONTACT

916-734-7875; dishapiro@ucdavis.edu

Maria Pagador

CONTACT

916-799-4932; pagadorm@saccounty.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a dissemination and implementation trial in which the study team is training staff at nine local community mental health centers to implement a screening protocol and stepped-care intervention. These clinics will be providing treatment and the study group will be evaluating it. There is no control group.

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: March 20, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (6)