Sacramento Clinical High Risk for Psychosis Stepped-Care Program (SCIP Step)

December 5, 2025 updated by: University of California, Davis

Increasing Access to Evidence-Based CHR-P Assessment and Treatment Via Stepped-Care in Community-based Settings

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study aims to increase the capacity to identify and treat youths at clinical high-risk for psychosis (CHRp) across Sacramento, CA by disseminating and implementing in community mental health clinics (CMHCs) universal screening and a stepped-care, team-based intervention that includes training and ongoing support in a Cognitive Behavioral Therapy package called Cognitive Behavioral Case Management (CBCM). The study is being conducted in nine non-psychosis specialty CMHCs across 5 agencies, all of which treat young people with public insurance (Medi-Cal/Medicaid) or no insurance. All youths aged 12-25 will be screened when beginning care and those who screen positive and agree will be assessed by the only specialty early psychosis clinic in the county, at the University of California-Davis. Thus the study also aims to triage this limited resource of specialized early psychosis expertise. CHRp+ youth will then begin a 2 year stepped-care intervention at their CMHCs and can move to the early psychosis specialty clinic if they still meet CHRp criteria after 2 years or develop psychosis. The specialty early psychosis service provides ongoing support and consultation.

Study Type

Interventional

Enrollment (Estimated)

223

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Elk Grove, California, United States, 95758
        • Recruiting
        • River Oak Center for Children
        • Contact:
      • Elk Grove, California, United States, 95758
        • Recruiting
        • Turning Point Community Programs
        • Contact:
          • Marisa Ciani, LCSW
          • Phone Number: 916-427-7141
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Department of Psychiatry and Behavioral Sciences; Early Psychosis Programs
        • Contact:
      • Sacramento, California, United States, 95820
        • Recruiting
        • University of California-Davis CAARE Diagnostic and Treatment Center
        • Contact:
      • Sacramento, California, United States, 95821
        • Recruiting
        • Capital Star Community Services
        • Contact:
      • Sacramento, California, United States, 95838

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Intellectual disability (IQ<70)
  2. Urgent clinical need for a higher level of care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive Behavioral Case Management
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
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+.
Other Names:
  • Cognitive Behavioral Therapy for those at clinical high risk for psychosis
  • team-based stepped-care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention.
Time Frame: 2, 3, or 4 years depending on site
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
Time Frame: 2, 3, or 4 years depending on site
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
Time Frame: 2, 3, or 4 years

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
Time Frame: 2, 3, or 4 years
  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.
Time Frame: from enrollment to the end of treatment at 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Colorado Symptom Index (MCSI)
Time Frame: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Self-report omnibus measure of symptom severity across multiple domains.
Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Global Impression Scale
Time Frame: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Single item self-assessment of overall life function.
Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Global Functioning: Social and Role Scales
Time Frame: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Clinician rated scales assessing social and role functioning.
Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Life and Treatment satisfaction
Time Frame: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Self-report likert scale questions that assess overall functioning, symptom severity, and satisfaction with various aspects of the trial treatment.
Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Barriers and Facilitators interviews
Time Frame: 6 months after enrollment and when their final treatment client completes treatment
Qualitative interviews with study clinicians and site leadership to identify barriers and facilitators to implementation.
6 months after enrollment and when their final treatment client completes treatment
Barriers and Facilitators Survey
Time Frame: 6 months after clinician's enrollment and again when their final client completes care
Survey created by study investigators to accompany qualitative interviews and assess opinions on the appropriateness and effectiveness of Cognitive Behavioral Case Management and stepped-care in this setting.
6 months after clinician's enrollment and again when their final client completes care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

Sacramento County Behavioral Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1989082
  • H79SM086150 (Other Grant/Funding Number: SAMHSA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Screening and treatment provided in this study occur at community mental health centers by community providers and is embedded within their care models. Sites are protective of data generated from the treatment consumers who are participating in this trial and each have asked to make their own determinations about data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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