Sacramento Clinical High Risk for Psychosis Stepped-Care Program

Официальное название

Increasing Access to Evidence-Based CHR-P Assessment and Treatment Via Stepped-Care in Community-based Settings

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention. [Срок оценки: 2, 3, or 4 years depending on site]
• Acceptability: Proportion of enrolled youths who move into each step of stepped-care [Срок оценки: 2, 3, or 4 years depending on site]
• Reach: Universal screening outcomes [Срок оценки: 2, 3, or 4 years]
• Reach: Number of community clinicians trained in specialized stepped care [Срок оценки: 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. [Срок оценки: from enrollment to the end of treatment at 2 years]

Вторичные конечные точки (6)

• Modified Colorado Symptom Index (MCSI) [Срок оценки: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)]
• Global Impression Scale [Срок оценки: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)]
• Global Functioning: Social and Role Scales [Срок оценки: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)]
• Life and Treatment satisfaction [Срок оценки: Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months)]
• Barriers and Facilitators interviews [Срок оценки: 6 months after enrollment and when their final treatment client completes treatment]
• Barriers and Facilitators Survey [Срок оценки: 6 months after clinician's enrollment and again when their final client completes care]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Intellectual disability (IQ\<70)
• Urgent clinical need for a higher level of care

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• 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

Публикации

• 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

Идентификаторы

NCT: NCT06640803 · 1989082 · H79SM086150

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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