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| ID | Type | Description | Link |
|---|---|---|---|
| H79SM086150 | Other Grant/Funding Number | SAMHSA |
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| Name | Class |
|---|---|
| Sacramento County Behavioral Health Services | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped-Care including Cognitive Behavioral Case Management | 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+. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention. | 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. | 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). | 2, 3, or 4 years depending on site |
| Reach: Universal screening outcomes | Number of youths who reach each stage of the screening pipeline including:
| 2, 3, or 4 years |
| Reach: Number of community clinicians trained in specialized stepped care |
| 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). | from enrollment to the end of treatment at 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Colorado Symptom Index (MCSI) | Self-report omnibus measure of symptom severity across multiple domains. | Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months) |
| Global Impression Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel I Shapiro, PhD | Contact | 916-734-7875 | dishapiro@ucdavis.edu | |
| Maria Pagador | Contact | 916-799-4932 | pagadorm@saccounty.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| River Oak Center for Children | Recruiting | Elk Grove | California | 95758 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41316062 | Derived | 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. |
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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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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.
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Single item self-assessment of overall life function.
| 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. | 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. | 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. | 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. | 6 months after clinician's enrollment and again when their final client completes care |
| Turning Point Community Programs | Recruiting | Elk Grove | California | 95758 | United States |
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| University of California Department of Psychiatry and Behavioral Sciences; Early Psychosis Programs | Recruiting | Sacramento | California | 95817 | United States |
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| University of California-Davis CAARE Diagnostic and Treatment Center | Recruiting | Sacramento | California | 95820 | United States |
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| Capital Star Community Services | Recruiting | Sacramento | California | 95821 | United States |
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| Heartland Child and Family Services | Recruiting | Sacramento | California | 95838 | United States |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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