Clinical trial NCT06640803: Sacramento Clinical High Risk for Psychosis Stepped-Care Program
Official title: Increasing Access to Evidence-Based CHR-P Assessment and Treatment Via Stepped-Care in Community-based Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Clinical High Risk for Psychosis
Ultra High Risk for Psychosis
Keywords: psychosis
stepped-care
psychosis screening
community-based care
dissemination and implementation
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Sacramento County Behavioral Health Services
First posted: 2024-10-15
Enrollment: 223
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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\&lt;70)
2. Urgent clinical need for a higher level of care

Primary outcomes:
measure: Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention.
timeFrame: 2, 3, or 4 years depending on site
measure: Acceptability: Proportion of enrolled youths who move into each step of stepped-care
timeFrame: 2, 3, or 4 years depending on site
measure: Reach: Universal screening outcomes
timeFrame: 2, 3, or 4 years
measure: Reach: Number of community clinicians trained in specialized stepped care
timeFrame: 2, 3, or 4 years
measure: Effectiveness: Number of youth who meet criteria for a clinical high risk for psychosis (CHRp) syndrome at each step of the intervention.
timeFrame: from enrollment to the end of treatment at 2 years
Secondary outcomes:
measure: Modified Colorado Symptom Index (MCSI)
timeFrame: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
measure: Global Impression Scale
timeFrame: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
measure: Global Functioning: Social and Role Scales
timeFrame: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
measure: Life and Treatment satisfaction
timeFrame: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)
measure: Barriers and Facilitators interviews
timeFrame: 6 months after enrollment and when their final treatment client completes treatment
measure: Barriers and Facilitators Survey
timeFrame: 6 months after clinician's enrollment and again when their final client completes care
Other outcomes:
Locations:
city: Elk Grove
country: United States
facility: River Oak Center for Children
state: California
city: Elk Grove
country: United States
facility: Turning Point Community Programs
state: California
city: Sacramento
country: United States
facility: University of California Department of Psychiatry and Behavioral Sciences; Early Psychosis Programs
state: California
city: Sacramento
country: United States
facility: University of California-Davis CAARE Diagnostic and Treatment Center
state: California
city: Sacramento
country: United States
facility: Capital Star Community Services
state: California
city: Sacramento
country: United States
facility: Heartland Child and Family Services
state: California
Study officials:
References: