Clinical trial NCT05846282: Students Rising Above: Offsetting the Health and Mental Health Costs of Resilience
Official title: Project STRIVE (STudents RIsing Above) - Offsetting the Health and Mental Health Costs of Resilience
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Internalizing Mental Health Symptoms
Allostatic Load
Health Complaints
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Claremont McKenna College
name: Fuller Seminary
name: Stanford University
First posted: 2023-05-06
Enrollment: 504
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to either the control condition (Study skills) or the experimental condition (STRVE).
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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. Investigators have established secure data tracking systems using a cloud-based online SharePoint site that facilitates routine reports for participant enrollment, and data collection status to ensure on-time completion and tracking of targeted enrollment and retention for each participant category. These reports will be discussed at weekly project meetings.Investigators have found that summarizing data from our tracking database at weekly research team meetings has been an effective strategy to monitor both enrollments and follow-up rates. 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. In calculating recruitment targets, Investigators deliberately made conservative estimates of recruitment rates so Investigators anticipate there should be more than sufficient numbers of youth to achieve our targets. Assumptions include 20% of 11 th grade students in the school eligible on basis of academic criteria, reduced by the % of non-BIPOC students, conservative estimate that 80% of BIPOC students would be eligible on the basis of family background characteristics, and an estimated 50% recruitment rate.

In our community-based research, Investigators have developed very effective ways of tracking participants for follow-up assessments. The research team will send reminder and thank you letters and will obtain multiple methods for contacting participants (email, phone numbers, physical addresses). The research team will be taking attendance weekly. After 2 unexplained absences, the study coordinator will contact participants via email and phone contact to problem solve barriers to attendance. The study coordinator will do up to 3 such contacts. If at any contact a participant indicates their intention to withdraw from the study, the study coordinator will cease contact, and record this as a study withdrawal.

While the investigators anticipate that there will be more than sufficient numbers of youth to meet recruitment targets, the investigators will use several strategies to address any challenges that arise. For example, if participants are declining to participate in the research assessments and recruitment falls below expectation due to low rates of consent/assent, investigators will obtain feedback regarding barriers to participation so investigators can problem-solve and address these barriers with prospective participants (e.g., the times during which intervention groups are offered). If rates of recruitment of target groups, Black, Latinx, and Asian American/Pacific Islander students, fall below expectations, investigators will examine barriers to participation and address these in partnership with key opinion leaders in the school communities. If rates of recruitment are lower than anticipated across the board, the research team in partnership with the schools may elect to broaden inclusion criteria, for example, by offering the intervention to additional grades (10 th or 12 th grades). For any such change investigators would secure IRB approval on an amendment to this application before proceeding.

Phase 2 Procedures: 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. Participants will receive a copy of the Research Participant Bill of Rights in a language in which they are fluent. Participants will review the consent forms after they have read and understood the Research Participant Bill of Rights. 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. All biological data collection procedures will use tools that are legally marketed devices that will only be used for purposes within their approved labeling. 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. Likewise, data entered electronically from the data collection paper forms will be linked only to a participant ID number. The participant tracking key linking IDs to personal identifying information will be stored separately in a file accessible only by the project investigators and data managers on this project. 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. The University of Trier will also be responsible for following standard protocol for analysis and will dispose of saliva samples after analyses are complete.

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. The researchers will show the participant a sample of hair to illustrate the amount of hair needed for the cortisol assay. The research team will follow the protocol proposed by the International Atomic Energy Agency, which is adopted by the Center of Disease Control and the US Environmental Protection Agency (EPA). 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. Samples will be kept until the end of data collection. 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).

Assessment of Risks \& Handling of Risks

Physical risks associated with the lab visit are considered minimal and are similar to those experienced as part of a general physical exam. Investigators will take steps to ensure that these risks are decreased where possible; The research staff will attempt to make participants as comfortable as possible with saliva sampling and inflammation collection procedures, they will take precautions with hair collection and take samples in inconspicuous locations on the scalp, and roughly 10 mm width of hair across the two locations. The research staff will ask participants to stand backward on the scale to minimize possible participant anxiety about their weight.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Intellectual Disability

Primary outcomes:
measure: Change in Internalizing Symptoms over time
timeFrame: Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up
measure: Change in Physical Health Complaints over time on the PROMIS scale
timeFrame: Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up
measure: Change in Physical Health Complaints over time on the CSSI-8
timeFrame: Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up
measure: Change in Hair Cortisol over time
timeFrame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up
measure: Change in Hair Dehydroepiandrosterone (DHEA) over time
timeFrame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up
measure: Change in Saliva Inflammatory Marker over time
timeFrame: Collected at baseline, Post-Assessment (13-weeks), and 12 month follow up
measure: Change in Hip-to-waist ratio
timeFrame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up
measure: Change in Resting Blood pressure (systolic and diastolic) mmHg (millimeters of mercury)
timeFrame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up
measure: Change in Resting Respiratory Sinus Arrhythmia bpm (beats per minute)
timeFrame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up
measure: Change in Body Mass Index (BMI) Percentile
timeFrame: Collected at baseline, post-assessment (13 weeks), and 12 month follow up
measure: Change in Allostatic Load over time
timeFrame: Collected at baseline, Post-Assessment (13-weeks), and 12 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Anna S Lau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.