PURSUIT: A Technologically Augmented School-based Program to Improve Child Coping and Prevent Substance Use.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: PURSUIT.
- Кому может быть актуально
- Состояния в реестре: Pediatric Pain, Anxiety, Mood, Stress. Базовые параметры: 8 лет — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The study investigators aim to test an online support platform for Michigan youth aged 8-18 years enrolled in elementary, middle, or high school and their parent/caregiver. The online support platform will be hosted on the Computerized Intervention Authoring System (CIAS) 3.0 and will provide evidence-based cognitive behavioral coping skills for physical (pain) and mental (stress, mood) health symptoms, with additional substance use prevention content for youth aged 12 and older. Evaluations will occur at baseline and then a post assessment approximately 8 weeks later.
Подробное описание
The study investigator's aims are to:
1. Evaluate the feasibility and acceptability of the PURSUIT online support platform using mixed methods. 2. Explore the impact of PURSUIT on youth's physical (pain) and mental health (stress, anxiety, mood, perceived risk of substance use) symptoms at post assessment.
Consented youth will complete a baseline assessment (week 1), and then will use the PURSUIT online platform (expected duration is 6 week), and complete a post assessment (week 8).
Within the PURSUIT platform, all youth will have access to tools teaching cognitive-behavioral strategies for managing mood, anxiety, stress, and physical pain. Youth aged 12 and older will have access to additional content presenting cognitive-behavioral strategies for reducing the risk of substance use.
Youth will provide data on their symptoms (e.g thoughts, mood, behaviors, sleep, pain, and stress) at baseline and post assessment. A caregiver will report on the child's demographics, adverse childhood experience (ACE) exposure, school performance/attendance and their own mood. At post-assessment, the youth will also be asked to take part in a brief, semi-structured interview regarding their experiences with PURSUIT.
Вмешательства
- Поведенческое PURSUIT
PURSUIT is an online self-management platform for youth aged 8-18 and one caregiver that provides cognitive-behavioral coping skills for physical and mental health symptoms, plus substance use prevention content for youth aged 12 and older.
Первичные конечные точки
- PURSUIT Feasibility-Youth Retention [Срок оценки: From baseline to post assessment, approximately 8 weeks]
- PURSUIT Feasibility/Acceptability [Срок оценки: From baseline to post-assessment, approximately 8 weeks.]
Вторичные конечные точки (12)
- Changes in pain, as measured by the Pain Visual Analog Scale (VAS) [Срок оценки: From baseline to post-assessment, approximately 8 weeks.]
- Change in functional disability, measured using the Functional Disability Inventory (FDI) [Срок оценки: From baseline to post-assessment, approximately 8 weeks.]
- Changes in post-traumatic stress disorder symptoms (PTSD), measured using the UCLA Reaction Index for DSM-5 Brief Screening Form [Срок оценки: From baseline to post-assessment, approximately 8 weeks.]
- Change in anxiety symptoms, measured using the Screen for Child Anxiety Related Disorders (SCARED) [Срок оценки: From baseline to post-assessment, approximately 8 weeks.]
- Change in depressive symptoms, measured using the PROMIS Pediatric Short Form 8a [Срок оценки: From baseline to post-assessment, approximately 8 weeks.]
- Change in fatigue symptoms; as measured by the PROMIS Pediatric Short Form 10a [Срок оценки: From baseline to post-assessment, approximately 8 weeks.]
- Change in sleep disturbance symptoms, measured using the PROMIS Pediatric Sleep Disturbance Short Form 8a [Срок оценки: From baseline to post-assessment; approximately 8 weeks]
- Change in youths' perceived risk of substance use; measured using Monitoring The Future items [Срок оценки: From baseline through post-assessment; approximately 8 weeks.]
- Change in youth's substance use behaviors; assessed using the Screening to Brief Intervention (S2B1) [Срок оценки: From baseline through post-assessment; approximately 8 weeks.]
- Changes in caregivers' depression, anxiety, and stress as measured by the Depression Anxiety and Stress Scales 21 (DASS21) [Срок оценки: From baseline to post-assessment, approximately 8 weeks.]
- Change in stress, measured by the PROMIS Pediatric Psychological Stress Experiences 8a [Срок оценки: From baseline to post-assessment; approximately 8 weeks]
- Patient Global Impression of Change [Срок оценки: post-assessment; approximately 8 weeks after baseline]
Критерии участия
Критерии включения
- Aged eight to 18 years
- Enrolled in a Michigan elementary, middle, or high school
Критерии исключения
- Age under 8
- Age over 18 years
- Non-enrollment in A Michigan school.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- Michigan State University — Grand Rapids
Идентификаторы
NCT: NCT07266740 · STUDY00011346 · G-2404-153994