Prevention and Early Identification for High Risk Youth in School-based Clinics (ALACRITY eSToRY R34 #1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 5
- 主要终点
- Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
研究概览
简要总结
The proposed research project provides a novel approach to screening, early assessment, and preventive interventions for high-risk youth in racial/ethnic/linguistically (REL)-diverse communities.
- The investigators assess a health promotion intervention as a way of reducing treatment disparities in REL-minority youth. This population is underrepresented in child psychiatry research. It is often excluded from clinical trials of medication or therapy because of challenges with transportation, literacy, resources, or other issues.
- The study will take place during or following a healthcare crisis and economic recession, making findings relevant to understanding the mechanisms by which hardship translates into youth mental illness.
- The innovative integration of online screening into school-based clinics and community-based settings in REL-minority communities is made possible by the combination of access to a new technology (CAT) in the context of a learning health community serving a REL-minority population.
- Empirical research on the impact of a resilience-based prevention intervention in youth and youth at risk is both innovative and much needed during this period of health, social and economic crisis.
详细描述
Four hundred high school students will be screened for psychiatric symptoms and functional impairment using the Kiddie Computerized Adaptive Testing (K-CAT) and the Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S) in CHA's catchment area (Cambridge, Chelsea, Everett, Malden, Revere, Somerville, Winthrop. Students will be classified into three tiers: normal, at risk, and clinical . The cut off scores that differentiate the tiers are drawn from the ROC values generated by the psychometrics of the measures themselves as follows:
- Tier 1: K-CAT Normal & WFIRS <0.8 - >1.0 (T <1SD).
- Tier 2: K-CAT Mild & WFIRS 0.8 - >1.0, K-CAT Moderate & WFIRS 0.8 - 1.0 (T between 1 and 1.5 SD), K-CAT Severe & WFIRS 0.8 - 1.0 (T between 1 and 1.5 SD)
- Tier 3: K-CAT Moderate & WFIRS >1.0 (T >1.5 SD), K-CAT Severe & WFIRS >1.0 (T >1.5 SD) If patients are symptomatic but not functionally impaired, status is determined by function because symptoms without impairment do not necessarily warrant intervention. If the patient is impaired but not symptomatic, the threshold is determined by symptoms because the patient may be impaired from factors other than the diagnosis. These scores are based on the results of the most severe module of either the K-CAT or the WFIRS. .All students will be eligible to participate in C2T, independent of how they are classified by Tier, unless they meet one of the exclusion criteria. Tier 3 will be informed that the participants' responses suggest that the participants are experiencing some symptoms which are causing them difficulty. As long as the participants are not assessed as critical imminent risk, Tier 3 will also be invited to participate in C2T.
A stepped wedge design with 3 clusters of 36 students each will be used to group students into clusters based on rolling recruitment into COPE2Thrive. The stepped wedge design assigns a random cluster to be switched from the control group to the C2T intervention group at either one, two, or three-week intervals starting at week 1 and ending at week 23 of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High school students in CHA's catchment area (Cambridge, Chelsea, Everett, Malden, Revere, Somerville, Winthrop)
- •Youth who are fluent in English, Haitian Creole, Portuguese, or Spanish.
- •Youth who experience at least some symptoms, defined as a K-CAT-S score (from Aim 1) of moderate on at least one diagnosis with at least mild functional impairment. Patients with more severe symptoms or functional impairment or who do not meet the
排除标准
- •are also eligible.
- •Inclusion Criteria for COPE2Thrive:
- •High school students in CHA's catchment area (Cambridge, Chelsea, Everett, Malden, Revere, Somerville, Winthrop)
- •Youth who are fluent in English, Haitian-Creole, Portuguese, or Spanish.
- •Youth who have completed WFIRS and K-CAT, and who do not meet the exclusion criteria.
- •Exclusion Criteria:
- •12th-graders will be excluded from the COPE2Thrive program since the participants will not be available for the study's duration.
- •Students who are already receiving behavioral health care.
- •Students who are considered to be seriously suicidal and in need of urgent care, in which case the participants would be ineligible based on the fact that the participants will be receiving behavioral health care.
研究组 & 干预措施
R34#1 Aim 2 COPE2Thrive Intervention
A three-group stepped wedge design was originally proposed with 108 youth. During initial screening, we identified 128 individuals met inclusion criteria but only 39 individuals agreed to participate in the study. We randomized these 39 individuals into three cohorts for the stepped wedge design: cohort 1 (n=10), cohort 2 (n=15), and cohort 3 (n=14). Cohort 1 received 1 week of treatment as usual, then initiated the COPE2Thrive intervention. Cohort 2 received 2 weeks of treatment as usual, then initiated the COPE2Thrive intervention. Cohort 3 received 3 weeks of treatment as usual then initiated the COPE2Thrive intervention.
干预措施: COPE2Thrive (Behavioral)
Control arm
The control arm includes the same 39 youth randomized to Cohort 1, 2, or 3 during the time period before they were switched into the COPE2THRIVE intervention.
干预措施: Usual care (Other)
结局指标
主要结局
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
时间窗: The time frame of assessment of the K-CAT-S is: baseline (at initiation of the intervention, which is 1-, 2-, or 3-weeks after initial screen); completion (1-3 weeks after baseline); and follow-up 3 months
The K-CAT-S is a computerized adaptive test for assessment of DSM 5 conditions in youth. Adaptive testing allows the assessment to be done in less than 10 minutes with high validity compared against diagnostic interviews. High scores indicate greater psychopathology. For each of six domains, the minimum score is 0, a score between 45-64 is moderate, a score greater than 65 is severe, and the maximum score is 100. For this primary outcome, the Total K-CAT was used, adding scores across all six domains for a range of 0-600. Change in the numeric level of these symptoms will be the primary outcome of the testing of the preliminary effectiveness of the COPE2Thrive intervention.
Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S)
时间窗: The time frame of assessment of the WFIRS-S is: baseline (at initiation of the intervention, which is 1-, 2-, or 3-weeks after initial screen); completion (1-3 weeks after baseline); and follow-up 3 months
The Weiss Functional Impairment Scale Self Report (WFIRS-S) is an assessment of the student's perception of how emotional and behavior problems have impacted functional impairment over the past month, across six domains including family, school, life skills, child's self-concept, social activities, and risky activities. Higher mean item scores indicate greater functional impairment. The minimum mean item score is 0, the maximum mean item score is 3, and the ROC population cut-off is 0.65. A mean change score of 0.25 is the minimal clinical important difference.
次要结局
- Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)(Single assessment at Baseline)
- Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)(Single assessment at baseline)
研究者
Margaret D Weiss, MD PhD
Principal Investigator
Cambridge Health Alliance