Students Rising Above: Offsetting the Health and Mental Health Costs of Resilience
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: STRIVE, Study Skills.
- Кому может быть актуально
- Состояния в реестре: Internalizing Mental Health Symptoms, Allostatic Load, Health Complaints. Базовые параметры: от 13 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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Официальное название
Project STRIVE (STudents RIsing Above) - Offsetting the Health and Mental Health Costs of Resilience
Обзор
Students who 'strive' to rise above significant stressors to achieve academic success are considered 'resilient'. However, youths' resilience in one domain (i.e. academic) can come at a cost in other domains including physical and mental health morbidities that are under-identified and under-treated. Previous research suggests that individuals from populations experiencing documented health disparities who exhibit a "striving persistent behavioral style" in the face of stress evince later health morbidities. Ironically, the same self-regulatory skills that promote academic achievement amid chronic stress can also result in physiological dysregulation that harms health and mental health. Self-regulatory processes that involve emotion suppression, experiential avoidance, and unmodulated perseverance can culminate in allostatic load which fuels health disparities and internalizing symptoms of depression and anxiety. The proposed mechanistic trial will utilize mindfulness training to permit examination of questions about the causal role of emotion regulation strategies linked to the striving persistent behavioral style in driving mental health and health morbidities among individuals from populations experiencing documented health disparities. The proposed Project STRIVE (STudents RIsing aboVE) will identify students who are academically resilient in the face of stress and will offer a tailored mindfulness intervention targeting self-regulation processes as a putative mechanism to interrupt the links between the striving persistent behavioral style and negative health outcomes. Investigators propose a multisite randomized trial randomizing 504 high achieving Black, Latinx, or Asian America/Pacific Islander students in 18 schools to receive a mindfulness intervention or an attention control condition focused on study skills. The study will: (1) test the effects of the STRIVE intervention on putative self-regulation mechanisms (emotion suppression, experiential avoidance, and unmodulated perseverance) among identified students, (2) test the effects of the STRIVE intervention on health and mental health outcomes at 12-month post-treatment, including biomarkers of allostatic load (cortisol, blood pressure, body-mass-index, waist/hip/neck circumference), health complaints, and internalizing symptoms, and (3) examine the mechanistic model linking striving persistent behavioral style and health outcomes within the STRIVE trial.
Подробное описание
The STRIVE and SOAR interventions will be trialed with students participating in public high schools with eligible students over 3 academic school years. Eligible students in participating schools will be randomized to either the SOAR curriculum or the STRIVE intervention. Students receiving the SOAR program will be delivered an academic skills curriculum (i.e., goal setting, organization and time-management, study and test-taking skills) to help them manage school-related demands. Students receiving the STRIVE intervention will receive a tailored mindfulness-based intervention that frames the need for emotion regulation skills to offset stress faced by youth. Both interventions will be led by project staff, graduate students, and post-doctoral fellows. Only students with documented parental consent for the study will be permitted to participate, students will also provide written assent in order to participate.
Phase 2 Participants: Up to 504 participants will be invited to participate in the project.
Investigators will continually monitor the enrollment of eligible students being referred to the study. Our success against anticipated milestones will also be evaluated formally on a tri-yearly basis. If our total recruitment falls behind anticipated goals, Investigators will develop a plan for "catching up" to milestones.
The research activities will take place during school hours. All eligible students will be invited to participate in the research project which will involve the completion of online surveys, the pre- and post-assessments, and a certificate of completion. All student participants who have consented will receive either the STRIVE intervention or the SOAR study skills curriculum in 12 1-hour sessions held at their high school, at times approved by school administrators. Invitations to participate in the research will be included in an information packet sent to students and caregivers, during information sessions, and in orientation videos. Only students with written parental consent to the study will be permitted to participate, students will also provide written assent in order to participate. Non-participating students will remain in their classrooms as usual.
Parent/caregiver measures will also be collected via an online questionnaire to assess health outcomes and family contextual factors.
Biological samples will be collected in this trial to assess intervention effects on biomarkers indicating the cumulative effects of stress on the body. Biological data collection will take place during the 90 min in-person health assessment at the school sites in a classroom or other private space assigned for this purpose by school administrators. Procedures will be administered by trained research assistants, project coordinators, graduate students, and post-doctoral fellows who have received specialized trained in the administration of these procedures. Care will be taken to explain the purpose of the data collection to assess the effects of stress on bodily systems, and participants and caregivers will be assured that no drug or genetic testing will be carried out on biological samples.
The bio-markers collected in this study are listed below. The bio-markers are intended to examine the effects of stress on bodily systems and no drug or genetic testing will be performed on samples. All biological samples and body measurements will be labeled only with participant IDs and no other identifying information. Details for the collection of biological samples during in-person health assessments baseline assessment, post-assessment, and 12-month follow-up are described below:
Saliva sample collection. Participants will be asked to deposit saliva into straws that drip saliva into a 2mL tube. Saliva samples will be taken four times during the in-person health assessment, to index baseline, reactivity to behavioral tasks, and recovery. Samples will be organized into standard cryostorage boxes (9x9 grids, 81 tubes) within insulated transportation containers prior to being frozen at Claremont McKenna College for temporary storage before assay. Saliva samples will be kept in locked cold storage within a locked room that is only accessible to study personnel. When data collection is complete, all saliva samples will be sent to the University of Trier for assessment and analysis. The data will be sent de-identified and samples will be destroyed after analyses are completed. Saliva will be assayed for cortisol, alpha-amylase, and dehydroepiandrosterone.
Hair sample collection. A small amount (15-20 mg) of hair will be collected from the participants at baseline assessment, post-assessment, and during 12-month follow-up. Hair samples will be cut from two or three locations at the back of the head, and only the first 3 cm of hair proximal to the scalp will be used for analysis. Samples will be stored in a zip lock bag labeled with the participant ID number in locked storage within a locked room that is only accessible to study personnel. The purpose of collecting these samples is to investigate the impact of our intervention on several stress markers (cortisol, corticosterone, testosterone, corticosterone, and dehydroepiandrosterone). The data will be de-identified and sent to the TU Dresden Laboratory for analysis. Samples will be destroyed 2 weeks after analyses are completed. No drug or genetic testing will be performed.
Body mass index will be assessed by collecting participant height and weight at baseline assessment, post-assessment, and during 12-month follow-up. BMI percentiles will be calculated as kg/m2, based on the Centers for Disease Control and Prevention (CDC) age and gender growth charts.
Waist and hip circumference will be assessed with a Gulick cloth measuring tape using established techniques at baseline assessment, post-assessment, and during 12-month follow-up. Two waist and hip measurements will be taken to the nearest mm and a third if the difference is 10mm or more.
Resting blood pressure will be assessed through systolic blood pressure (SBP) readings at baseline assessment, post-assessment, and during 12-month follow-up. Readings are taken from a vital signs monitor, the OMRON 5 Series Wireless Upper Arm Blood Pressure Monitor (Model BP7250). The mean of three SBP readings will be used in analyses.
Resting heart rate variability (HRV) will be assessed over a 5-minute period in a seated posture using a physiological acquisition system, EmWave Pro, at baseline assessment, post-assessment, and during 12-month follow-up. EmWave Pro captures heart rate and HRV through an infrared pulse plethysmograph ear sensor or finger sensor, depending on the participant's physical constraints (e.g., poor circulation on the hand, too much ear jewelry, etc).
Вмешательства
- Поведенческое STRIVE
The STRIVE intervention will include all activities and BREATHE skill training components of L2B with content framed within the needs of high achieving college-bound students who can benefit from health promoting practices to offset the costs of resilience. The intervention will include twelve 60-minute group sessions, with two sessions on each of the six core themes. Each session will include an opening mindful movement, short didactic presentation of the topic or theme of that week, group acti - Поведенческое Study Skills
The sessions will focus on goal setting (4 sessions), organization and time management (3 sessions), and study skills for reading comprehension, writing papers, note-taking, and test-taking (4 sessions). Parallel to the final L2B session, the last meeting will include activities to share and reflect on how students plan to incorporate and sustain new skills.
Первичные конечные точки
- Change in Internalizing Symptoms over time [Срок оценки: Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up]
- Change in Physical Health Complaints over time on the PROMIS scale [Срок оценки: Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up]
- Change in Physical Health Complaints over time on the CSSI-8 [Срок оценки: Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up]
- Change in Hair Cortisol over time [Срок оценки: Collected at baseline, post-assessment (13 weeks), and 12 month follow up]
- Change in Hair Dehydroepiandrosterone (DHEA) over time [Срок оценки: Collected at baseline, post-assessment (13 weeks), and 12 month follow up]
- Change in Saliva Inflammatory Marker over time [Срок оценки: Collected at baseline, Post-Assessment (13-weeks), and 12 month follow up]
- Change in Hip-to-waist ratio [Срок оценки: Collected at baseline, post-assessment (13 weeks), and 12 month follow up]
- Change in Resting Blood pressure (systolic and diastolic) mmHg (millimeters of mercury) [Срок оценки: Collected at baseline, post-assessment (13 weeks), and 12 month follow up]
- Change in Resting Respiratory Sinus Arrhythmia bpm (beats per minute) [Срок оценки: Collected at baseline, post-assessment (13 weeks), and 12 month follow up]
- Change in Body Mass Index (BMI) Percentile [Срок оценки: Collected at baseline, post-assessment (13 weeks), and 12 month follow up]
Критерии участия
Критерии включения
- Enrolled in 10th or 11th grade at a participating high school
- Black, Latinx, Asian American/Pacific Islander, or American Indian/Alaskan Native
- High achieving (e.g., GPA above 3.5 and/or in the top 20% of their grade, enrolled in advanced classes such as AP/IB/honors classes)
Критерии исключения
- Intellectual Disability
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
США · 1 центр
- University of California — Los Angeles
Публикации
- Doan SN, Yu SH, Wright B, Fung J, Saleem F, Lau AS. Resilience and Family Socialization Processes in Ethnic Minority Youth: Illuminating the Achievement-Health Paradox. Clin Child Fam Psychol Rev. 2022 Mar;25(1):75-92. doi: 10.1007/s10567-022-00389-1. Epub 2022 Feb 24. PMID 35201542
- Deppisch LM, Centeno JA, Gemmel DJ, Torres NL. Andrew Jackson's exposure to mercury and lead: poisoned president? JAMA. 1999 Aug 11;282(6):569-71. doi: 10.1001/jama.282.6.569. PMID 10450719
- Lau AS, Fung JJ, Adjah FT, Arce AM, Du H, Doan SN. Interrupting the "Costs of Competence" Through Mindfulness Intervention for High Achieving Minoritized Students: A Protocol for the Project STRIVE Mechanistic Trial. Mental Health Sci. 2025 Jun;3(2):e70011. doi: 10.1002/mhs2.70011. Epub 2025 Mar 21. PMID 40969841
Идентификаторы
NCT: NCT05846282 · R37MH128729