Sacramento Clinical High Risk for Psychosis Stepped-Care Program

NCT ID: NCT06640803

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2026-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clinical High Risk for Psychosis Ultra High Risk for Psychosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Stepped-Care including Cognitive Behavioral Case Management

Intervention Type 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+.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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+.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cognitive Behavioral Therapy for those at clinical high risk for psychosis team-based stepped-care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sacramento County Behavioral Health Services

UNKNOWN

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

River Oak Center for Children

Elk Grove, California, United States

Site Status RECRUITING

Turning Point Community Programs

Elk Grove, California, United States

Site Status RECRUITING

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

Sacramento, California, United States

Site Status RECRUITING

University of California-Davis CAARE Diagnostic and Treatment Center

Sacramento, California, United States

Site Status RECRUITING

Capital Star Community Services

Sacramento, California, United States

Site Status RECRUITING

Heartland Child and Family Services

Sacramento, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daniel I Shapiro, PhD

Role: CONTACT

916-734-7875

Maria Pagador

Role: CONTACT

916-799-4932

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tina Traxler, PhD

Role: primary

916-226-2833

Marisa Ciani, LCSW

Role: primary

916-427-7141

Daniel I Shapiro, Phd

Role: primary

916-734-7875

Dawn M Blacker, PhD

Role: primary

916-761-6713

Nicole Stiving, LCSW

Role: primary

916-584-7800

Jerri Ford, LMFT

Role: primary

916-418-0828

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H79SM086150

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1989082

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.