Increasing Access to Evidence-Based CHR-P Assessment and Treatment Via Stepped-Care in Community-based Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 223
- 试验地点
- 12
- 主要终点
- Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Intellectual disability (IQ<70)
- •Urgent clinical need for a higher level of care
结局指标
主要结局
Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention.
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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).
Feasibility: The number of youth at clinical high risk for psychosis enrolled in stepped care over the course of the intervention.
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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).
次要结局
- Modified Colorado Symptom Index (MCSI)(Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months))
- Global Impression Scale(Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months))
- Global Functioning: Social and Role Scales(Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months))
- Life and Treatment satisfaction(Baseline, 6-, 12-, 18-, 24-months, or study exit (up to 24 months))
- Barriers and Facilitators interviews(6 months after enrollment and when their final treatment client completes treatment)
- Barriers and Facilitators Survey(6 months after clinician's enrollment and again when their final client completes care)