Clinical High Risk for PsychosisSCIP StepNCT06640803
Sacramento Clinical High Risk for Psychosis Stepped-Care Program
A study testing Stepped-Care including Cognitive Behavioral Case Management in people with Clinical High Risk for Psychosis and Ultra High Risk for Psychosis, run by University of California, Davis at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Clinical High Risk for Psychosis, Ultra High Risk for Psychosis
- What is being tested?
- Stepped-Care including Cognitive Behavioral Case Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Mar 2023to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Intellectual disability (IQ\<70)
- Urgent clinical need for a higher level of care
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
River Oak Center for Children
Elk Grove, California, 95758
Tina Traxler, PhD, 916-226-2833, ttraxler@riveroak.org
- Recruiting
Turning Point Community Programs
Elk Grove, California, 95758
Marisa Ciani, LCSW, 916-427-7141
- Recruiting
University of California Department of Psychiatry and Behavioral Sciences; Early Psychosis Programs
Sacramento, California, 95817
Daniel I Shapiro, Phd, 916-734-7875, dishapiro@ucdavis.edu
- Recruiting
University of California-Davis CAARE Diagnostic and Treatment Center
Sacramento, California, 95820
Dawn M Blacker, PhD, 916-761-6713, dmblacker@ucdavis.edu
- Recruiting
Capital Star Community Services
Sacramento, California, 95821
Nicole Stiving, LCSW, 916-584-7800, nstiving@starsinc.com
- Recruiting
Heartland Child and Family Services
Sacramento, California, 95838
Jerri Ford, LMFT, 916-418-0828, jerri.ford@doingwhateverittakes.org
About this study
Official title: 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.
Read the 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.
- Being tested
- Stepped-Care including Cognitive Behavioral Case Management
- Keywords
- psychosis, stepped-care, psychosis screening, community-based care, dissemination and implementation
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped-Care including Cognitive Behavioral Case ManagementBehavioural
Also called Cognitive Behavioral Therapy for those at clinical high risk for psychosis, team-based stepped-care
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+.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Stepped-Care including Cognitive Behavioral Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention.
- Duration of enrollment in the stepped-care intervention for young people identified as at clinical high-risk for psychosis through their community health setting.
Measured: 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).
Measured: 2, 3, or 4 years depending on site
Reach: Universal screening outcomes
Number of youths who reach each stage of the screening pipeline including:
- Number of youths screened.
- Number of screened youths who score positive on the screening measure (Prodromal Questionnaire Brief).
Measured: 2, 3, or 4 years
Reach: Number of community clinicians trained in specialized stepped care
- The number of clinicians employed at targeted community mental health agencies who complete training in Cognitive Behavioral Case management (CBCM).
- The number of these CBCM trained clinicians who enroll in the trial.
Measured: 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).
Measured: from enrollment to the end of treatment at 2 years
Secondary outcomes (6)
Modified Colorado Symptom Index (MCSI)
Self-report omnibus measure of symptom severity across multiple domains.
Measured: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Global Impression Scale
Single item self-assessment of overall life function.
Measured: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Global Functioning: Social and Role Scales
Clinician rated scales assessing social and role functioning.
Measured: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Life and Treatment satisfaction
Self-report likert scale questions that assess overall functioning, symptom severity, and satisfaction with various aspects of the trial treatment.
Measured: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
Barriers and Facilitators interviews
Qualitative interviews with study clinicians and site leadership to identify barriers and facilitators to implementation.
Measured: 6 months after enrollment and when their final treatment client completes treatment
Barriers and Facilitators Survey
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.
Measured: 6 months after clinician's enrollment and again when their final client completes care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Mar 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical High Risk for PsychosisStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 223 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Sacramento County Behavioral Health Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640803
- Sponsor's protocol ID
- 1989082
- Other IDs
- H79SM086150
- Acronym
- SCIP Step
- Status last verified
- Dec 2025
- First submitted
- 4 Oct 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Chen YL, Ereshefsky S, Yau S, Gonzalez A, Joo S, Niendam T, Shapiro D. Stepped care involving cognitive behavioral therapy for young people at clinical high-risk for psychosis in community settings: longitudinal intervention study protocol. BMC Psychiatry. 2025 Nov 28;26(1):3. doi: 10.1186/s12888-025-07597-3.
PubMed 41316062
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Access to Evidence-Based CHR-P Assessment and Treatment Via Stepped-Care in Community-based Settings
- ClinicalTrials.gov ID
- NCT06640803
- Acronym / sponsor ID
- SCIP Step / 1989082
- Keywords
- psychosis, stepped-care, psychosis screening, community-based care, dissemination and implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 223 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Sacramento County Behavioral Health Services
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Case Management | Experimental | Behavioral: Stepped-Care including Cognitive Behavioral Case ManagementOnce 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. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Intellectual disability (IQ\<70)
- Urgent clinical need for a higher level of care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped-Care including Cognitive Behavioral Case ManagementAlso: Cognitive Behavioral Therapy for those at clinical high risk for psychosis, team-based stepped-careStep 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+. | Behavioural | Cognitive Behavioral Case Management |
Primary outcome
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.
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).
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).
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.
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).
6 secondary outcomes
Modified Colorado Symptom Index (MCSI)
Time frame: 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)
Global Functioning: Social and Role Scales
Time frame: 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)
Barriers and Facilitators interviews
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Derived from this study: PubMed 41316062Chen YL, Ereshefsky S, Yau S, Gonzalez A, Joo S, Niendam T, Shapiro D. Stepped care involving cognitive behavioral therapy for young people at clinical high-risk for psychosis in community settings: longitudinal intervention study protocol. BMC Psychiatry. 2025 Nov 28;26(1):3. doi: 10.1186/s12888-025-07597-3.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped-Care including Cognitive Behavioral Case Management in people with Clinical High Risk for Psychosis and Ultra High Risk for Psychosis, run by University of California, Davis at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel I Shapiro, PhD (916-734-7875, dishapiro@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06640803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.