Sacramento Clinical High Risk for Psychosis Stepped-Care Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stepped-Care including Cognitive Behavioral Case Management.
- Who it may be relevant to
- Registry conditions: Clinical High Risk for Psychosis, Ultra High Risk for Psychosis. Basic parameters: 12 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Increasing Access to Evidence-Based CHR-P Assessment and Treatment Via Stepped-Care in Community-based Settings
Overview
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.
Interventions
- 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
Primary outcome measures
- 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]
- Acceptability: Proportion of enrolled youths who move into each step of stepped-care [Time frame: 2, 3, or 4 years depending on site]
- Reach: Universal screening outcomes [Time frame: 2, 3, or 4 years]
- Reach: Number of community clinicians trained in specialized stepped care [Time frame: 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]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Intellectual disability (IQ\<70)
- Urgent clinical need for a higher level of care
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- River Oak Center for Children — Elk Grove
- Turning Point Community Programs — Elk Grove
- University of California Department of Psychiatry and Behavioral Sciences; Early Psychosis — Sacramento
- University of California-Davis CAARE Diagnostic and Treatment Center — Sacramento
- Capital Star Community Services — Sacramento
- Heartland Child and Family Services — Sacramento
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. PMID 41316062
Identifiers
NCT: NCT06640803 · 1989082 · H79SM086150