Sacramento Clinical High Risk for Psychosis Stepped-Care Program
- Conditions
- Clinical High Risk for PsychosisUltra High Risk for Psychosis
- Registration Number
- NCT06640803
- Lead Sponsor
- University of California, Davis
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 223
- 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
- Intellectual disability (IQ<70)
- Urgent clinical need for a higher level of care
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention. 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 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 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 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. 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).
- Secondary Outcome Measures
Name Time Method Modified Colorado Symptom Index (MCSI) Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months) Self-report omnibus measure of symptom severity across multiple domains.
Global Impression Scale Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months) Single item self-assessment of overall life function.
Global Functioning: Social and Role Scales Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months) Clinician rated scales assessing social and role functioning.
Life and Treatment satisfaction 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.
Barriers and Facilitators interviews 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.
Barriers and Facilitators Survey 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.
Trial Locations
- Locations (6)
River Oak Center for Children
🇺🇸Elk Grove, California, United States
Turning Point Community Programs
🇺🇸Elk Grove, California, United States
University of California Department of Psychiatry and Behavioral Sciences; Early Psychosis Programs
🇺🇸Sacramento, California, United States
University of California-Davis CAARE Diagnostic and Treatment Center
🇺🇸Sacramento, California, United States
Capital Star Community Services
🇺🇸Sacramento, California, United States
Heartland Child and Family Services
🇺🇸Sacramento, California, United States