Summary

Eligibility
for people ages 13 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California
Dates
study started
study ends around
Principal Investigator
by Anna S Lau, PhD

Description

Summary

Students in marginalized communities who 'strive' to rise above adversity 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 Black, Indigenous and People of Color (BIPOC) who exhibit a "striving persistent behavioral style" in the face of adversity 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 BIPOC. The proposed Project STRIVE (STudents RIsing aboVE) will identify BIPOC students who are academically resilient in the face of disadvantage 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, socioeconomically disadvantaged Black, Latinx and Asian American 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 BIPOC 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.

Official Title

Project STRIVE (STudents RIsing Above) - Offsetting the Health and Mental Health Costs of Resilience

Details

The STRIVE and SOAR interventions will be trialed with students participating in public high schools with eligible BIPOC 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 including racialized stress and academic stress faced by diverse youth. Both interventions will be led by racially/ethnically diverse 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 our eligible BIPOC 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).

Keywords

Internalizing Mental Health Symptoms, Allostatic Load, Health Complaints, STRIVE, Study Skills

Eligibility

You can join if…

Open to people ages 13 years and up

  • Enrolled in 10th or 11th grade at a participating high school
  • Identify as 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)

You CAN'T join if...

  • Intellectual Disability

Location

  • University of California accepting new patients
    Los Angeles California 90049 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05846282
Study Type
Interventional
Participants
Expecting 504 study participants
Last Updated