A Framework for Research in Emerging Adults: Stepped Care for Youth at Risk of Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 3
- 主要终点
- Scale of Psychosis Risk Symptoms
研究概览
简要总结
The study will recruit 60 young people who meet established criteria for being at clinical high risk for psychosis. They will be offered a range of psychological interventions starting with the most benign treatments in different steps. At step 1 they will be offered individual or group support and if there is no improvement they will be offered more intensive CBT individual therapy or CBSST group therapy. Assessments will occur at baseline, 6,12 and 18 months
详细描述
In treating youth at clinical high risk of developing psychosis we have not been able to address what treatment to offer first and when to offer more intense and, ultimately, more costly treatments. The goals of achieving Precision Health objectives require that these questions be addressed through research.
The overall aim is to determine the most effective and efficient way to offer active and maintenance treatment resources for CHR youth. The first step would be to offer a range of treatments starting with the most benign as advocated in the McGorry and Hickie stage model. We will use this project to test whether clinical staging will improve prediction of prognosis and result in improved matching of treatment. The specific objectives of this project are: (1) to determine which and what proportion of participants would remit (i) within the first 1-2 months of treatment, (ii) after a brief supportive therapy, (iii) after longer term, focused psychological interventions such as CBT, CBSST and family intervention and (iv) how many make use of medications; (2) to determine adherence of CHR individuals to different treatments; and (3) to determine the need for maintenance treatment. To assess these objectives the following outcomes will be determined:
- Improvement of Attenuated Psychotic Symptoms
- Improved social functioning as rated by Global: Social Functioning
- Percentage of the sample that demonstrate either symptomatic or functional improvement after Step 1 treatments and do not require to move to Step 2 treatments.
- Percentage of sample that move to Step 2 Treatments and the percentage that achieve improvement in either symptoms or functioning.
- Percentage of participants allocated to a given treatment that adhere to the treatment.
Participants will be between ages 12 and 30. We will recruit 60 participants who meet well-established criteria for clinical high risk for psychosis based on the Structured Interview for Psychosis-Risk Syndromes (SIPS).
Assessments will be conducted at baseline and 2, 6, 12, and 18 months after baseline. Assessments consist of clinical assessments. Clinical raters will be experienced raters and will be trained on all clinical measures and routine reliability checks will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meeting SIPS criteria for clinical high risk for psychosis
排除标准
- •meeting criteria for any current or past axis I psychotic disorder, IQ less than 70, or past or current history of a clinically significant central nervous system disorder.
研究组 & 干预措施
Open treatment
Supportive therapy followed by CBT
干预措施: Supportive therapy and CBT (Behavioral)
结局指标
主要结局
Scale of Psychosis Risk Symptoms
时间窗: Baseline and 18 months
Individuals' clinical symptoms will be measured using scores on positive symptoms on the SOPS.
次要结局
- Global Functioning Scale: Social and Role(Baseline and 18 months)
研究者
Jean Addington, PhD
Professor
University of Calgary