- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04935710
Профилактика и раннее выявление молодежи из группы высокого риска в школьных клиниках
Профилактика и раннее выявление молодежи из группы высокого риска в школьных клиниках (ALACRITY ESToRY R34 #1)
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Massachusetts
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Cambridge, Massachusetts, Соединенные Штаты, 02138-4125
- CHA-Teen Health Center at Cambridge Rindge and Latin School
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Cambridge, Massachusetts, Соединенные Штаты, 02141-1047
- CHA Health Equity Research Lab
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Cambridge, Massachusetts, Соединенные Штаты, 02141
- Community
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Everett, Massachusetts, Соединенные Штаты, 02149-5128
- CHA Teen Health Center at Everett High School
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Somerville, Massachusetts, Соединенные Штаты, 02143-1740
- CHA Teen Connections at Somerville High School
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
- 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 exclusion criteria 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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: R34#1 Aim 2 COPE2Thrive Intervention
A three-group stepped wedge design was proposed. 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. |
Cognitive Behavioral Therapy-based program to help teens deal with anxiety, stress and depression by showing them how to develop skills needed to stop negative thoughts and start thinking and behaving in more positive ways. |
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Активный компаратор: 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. |
The control group receives usual care for youth at risk in the area of study.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Kiddie Computerized Adaptive Testing Self Report (K-CAT-S)
Временное ограничение: 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. |
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
|
|
Weiss Functional Impairment Rating Scale - Self Report (WFIRS-S)
Временное ограничение: 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. |
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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Kiddie Computerized Adaptive Testing Parent Report(K-CAT-P)
Временное ограничение: Single assessment at Baseline
|
We administered a single assessment of The Kiddie Computerized Adaptive Testing (K-CAT-P) to participants' parents at baseline to obtain collateral parent report of youth symptoms. The scoring metrics of this testing are identical to the Kiddie Computerized Adaptive Testing Student Report (K-CAT-S). The Kiddie Computerized Adaptive Testing Parent Report (K-CAT-P) screener provides a combined numeric score for each module based on validated quantitative comparisons. Higher scores indicate higher levels of symptoms. The minimum score for any module is 0, a numeric score between 45-64 for any module is considered moderate, a numeric score of 65 or above for any module is considered severe, and the maximum score for any module is 100. Scores for each of the six modules are reported. |
Single assessment at Baseline
|
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Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P)
Временное ограничение: Single assessment at baseline
|
We administered a single assessment of the Weiss Functional Impairment Scale Parent Report (WFIRS-P) to participants' parents at baseline to obtain collateral parent data. The Weiss Functional Impairment Scale Parent Report (WFIRS-P) is an assessment of the parent's perception of the child's functional impairment over the past month, across six domains including family, school learning and behavior, 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 clinically important difference. Scores for each of the six domains are reported. |
Single assessment at baseline
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Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Benjamin Cook, PhD, Health Equity Research Lab
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- ALACRITY eSToRY R34 #1
- P50MH126283 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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