Developing Biomarker-Supported SSD Prevention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire
研究概览
简要总结
The purpose of this study is to compare the effect of a brief family-based psychosocial intervention that addresses modifiable SSD risk factors on persistent and distressing psychotic-like experiences in children and young adults with a family history of SSD and high versus low baseline SSD-like brain patterns
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
- 9 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family history of SSD (defined as first-degree (e.g., a parent or a sibling), second-degree (e.g., an uncle or a grandparent), or other combinations of biological relatives in the family have or likely have a diagnosis of SSD or other closely related severe mental illnesses equivalent to at least 25% of genetic sharing) per medical record review and/or parent/legal guardian report and confirmed by a structured interview
- •screening positive for two or more risk factors targeted by the intervention
- •Participants and parent(s)/legal guardian(s) agree to participate
- •psychiatrically stable and have no major changes in antidepressant, stimulant, or antipsychotic medication in the past 4 weeks.
排除标准
- •Current or past history of psychotic disorders or clinical high risk for psychosis (CHR-p) per study interview
- •Current or past antipsychotic medication use to specifically treat a psychotic disorder
- •major medical and neurological conditions
- •moderate to severe intellectual disabilities or mild intellectual disabilities but expected to have difficulty completing the study assessments;
- •current drug or alcohol use that impacts functioning and study engagement;
- •Not able to give assent, permission, or consent.
- •Not able to undergo MRI.
结局指标
主要结局
Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire
时间窗: Baseline, 8 weeks, end of intervention (16 weeks after baseline ), 1-year follow up
This is a 21 item questionnaire and items are scored as 0 (symptom not endorsed) or 1 (symptom endorsed). Items endorsed are further assessed for level of distress (1-5) and chronicity (present 6 months, 1 year, 2 years, or more than 2 years ago). The total symptom score is calculated as the sum of distress ratings of all items at baseline with 1) "Did it bother you?" answered "Y" AND 2) endorsed as distressing at one or more previous time points. The range of the total symptom score is 0 to 105. Higher scores indicate greater distressing and persistent psychotic-like experiences.
次要结局
- Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery(Baseline, end of intervention (16 weeks after baseline ), 1-year follow up)
- Change in psychopathology measured by the Child Behavior Checklist (CBCL)(Baseline, end of intervention (16 weeks after baseline ), 1-year follow up)
- Change in stress level measured by the Perceived Stress Scale (PSS)(Baseline, end of intervention (16 weeks after baseline ), 1-year follow up)
研究者
Yizhou Ma
Instructor
The University of Texas Health Science Center, Houston