Digital Strategies to Advance Help-Seeking in Youth at Clinical High Risk for Developing Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25,000
- 试验地点
- 1
- 主要终点
- Aim 1: Proportion of participants in each help-seeking category
研究概览
简要总结
This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Leveraging the Health Action Process Approach (HAPA) model, this study will identify help-seeking subtypes in 25,000 youth who screen positive for psychosis-risk on Mental Health America's national online screening platform, iteratively develop and test theory and data-driven, personalized strategies to advance help-seeking using Micro-Randomized Trials and a Sequential Multiple Assignment Randomized Trial, identify the most accurate CHR screening threshold in an online environment, and link youth, when indicated, to local clinical care via Accelerating Medicines Partnership - Schizophrenia (AMP-SCZ), a NIH funded national network of CHR programs throughout the US. This academic-industry partnership aims to curate one of the largest datasets of youth with CHR, and to develop effective strategies to enhance early help-seeking, in a population where help-seeking is critical and a significant barrier to care.
详细描述
Aim 1: Characterize help-seeking patterns in 25,000 youth who score above Prodromal-Questionnaire (PQ-B) threshold. H1a: Youth will cluster into (1) pre-intenders (take the PQ-B and engage with educational content), (2) intenders (initiate a text exchange with a Strong365 peer navigator (3) actors (advance from texting to clinical assessment with a Strong365 clinician over phone/video) and (4) super-actors (advance from assessment to AMP-SCZ intake). Data will include online metadata (time spent online, # of resources viewed, time spent to complete the PQ-B, # of texts initiated/exchanged), self-report (demographics, symptom type and severity, PQ-B score, goals/needs, self-efficacy), and natural language. H1b (Strong365 only): Natural Language Processing (NLP) of data extracted from participant/provider interactions over text and video will identify linguistic markers of HAPA stages: intender, actor, super-actor. Models based on HAPA stages, along with behavioral features (i.e., message timing, frequency, response lag) will predict help-seeking advancement vs. disengagement. Top predictive features will be used to inform the crafting of help-seeking advancement strategies to be tested in MRTs (Aim 3).
Aim 2: To ensure that those who complete the PQ-B are directed appropriately, this study will establish the most accurate threshold for identifying CHR online. H2: Using data from population-based PQ-B screening, the investigators predict that a total distress score of 20+ will generate the highest diagnostic odds ratio with a sensitivity of at least 80% online, as determined by remote clinical assessment. For the remainder of the study, the threshold score that maximizes specificity and sensitivity will be used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 29 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 12-29 years
- •Living within a 50-mile radius of a US based AMP-SCZ site
- •Able to complete the English language PQ-B on MHA's screening platform
排除标准
- 未提供
结局指标
主要结局
Aim 1: Proportion of participants in each help-seeking category
时间窗: 1 year
Data from participants, including online metadata (time spent online, # of resources viewed, time spent to complete the PQ-B, # of texts initiated/exchanged), self-report (demographics, symptom type and severity, PQ-B score, goals/needs, self-efficacy), and natural language will be used to cluster participants into 4 categories: (1) Pre-intenders (take the PQ-B); (2) Intenders (initiate a text exchange with a peer navigator; (3) Actors (advance to clinical assessment); and (4) Super-actors (advance to intake).
Aim 2: Threshold score for identifying Clinical High-Risk Youth online
时间窗: 1 year
This score will be determined using data from population-based PQ-B screening. A total distress score of 20+ is predicted to generate the highest diagnostic odds ratio with a sensitivity of at least 80% online, as determined by remote clinical assessment. For the remainder of the study, a threshold score that maximizes specificity and sensitivity will be used.
次要结局
未报告次要终点
研究者
Michael Birnbaum
Asst Professor of Clinical
Columbia University
