NCT05846282

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2023Jun 2027

Study Start

First participant enrolled

January 9, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

March 14, 2023

Last Update Submit

March 4, 2026

Conditions

Outcome Measures

Primary Outcomes (11)

  • Change in Internalizing Symptoms over time

    The Depression, Anxiety, Stress Scales (DASS) is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety, and stress. The research team will assess a change in internalizing symptoms at different timepoints. For example, from Baseline to mid-assessment, mid-assessment to post-assessment, baseline to post-assessment, and baseline to 12-month follow up. The minimum score is 0 and the maximum score is 21. Higher scores indicate greater severity of negative emotional symptoms.

    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

    Utilized Two-item Patient Reported Outcomes Measurement and Information System (PROMIS) global physical and mental health scale to measure participant self-reported health. The research team will assess a change in self-reported health at different timepoints. For example, from Baseline to mid-assessment, mid-assessment to post-assessment, baseline to post-assessment, and baseline to 12-month follow up. The overall score is the sum of the two items, the minimum score is 2 and the maximum score is 10. Higher scores reflect better self-reported health.

    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

    Utilized the Children's Somatic Symptoms Inventory (CSSI-8) which measures the extent to which youth are bothered by various nonspecific somatic symptoms. The research team will assess a change in internalizing symptoms at different timepoints. For example, from Baseline to mid-assessment, mid-assessment to post-assessment, baseline to post-assessment, and baseline to 12-month follow up. The minimum score is 0 and the maximum score is 32. Higher scores indicate greater somatic distress.

    Collected at baseline, Mid-Assessment (Week 6), Post-Assessment (Week 13), and 12 month follow up

  • Change in Hair Cortisol over time

    The research team will collect hair samples to measure hair cortisol (picograms per milligram). The research team will assess a change in hair cortisol at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

    Collected at baseline, post-assessment (13 weeks), and 12 month follow up

  • Change in Hair Dehydroepiandrosterone (DHEA) over time

    The research team will collect hair samples to measure hair dehydroepiandrosterone (DHEA) (picograms per milligram). The research team will assess a change in hair DHEA at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

    Collected at baseline, post-assessment (13 weeks), and 12 month follow up

  • Change in Saliva Inflammatory Marker over time

    The research team will collect saliva samples from research participants. Interleukin-6 (Il-6) will be assayed from saliva. IL-6 is expressed as pg/ml (picograms per milliliter). The research team will assess a change salivary inflammation levels at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

    Collected at baseline, Post-Assessment (13-weeks), and 12 month follow up

  • Change in Hip-to-waist ratio

    The research team will collect hip and waist measurements in centimeters (cm). The research team will assess a change in hip-to-waist ratio at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

    Collected at baseline, post-assessment (13 weeks), and 12 month follow up

  • Change in Resting Blood pressure (systolic and diastolic) mmHg (millimeters of mercury)

    The research team will collect resting blood pressure (systolic and diabolic) mmHg (millimeters of mercury). The research team will assess a change in resting blood pressure at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

    Collected at baseline, post-assessment (13 weeks), and 12 month follow up

  • Change in Resting Respiratory Sinus Arrhythmia bpm (beats per minute)

    The research team will collect resting respiratory sinus Arrhythmia bpm. The research team will assess a change in resting respiratory sinus arrhythmia at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

    Collected at baseline, post-assessment (13 weeks), and 12 month follow up

  • Change in Body Mass Index (BMI) Percentile

    The research team will collect weight in kilograms and height in meter to calculate the BMI percentile. Once the BMI is calculated (calculated based on weight in kilograms divided by height in meters), it will be compared to children of the same sex and age. The research team will assess a change in BMI percentiles at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

    Collected at baseline, post-assessment (13 weeks), and 12 month follow up

  • Change in Allostatic Load over time

    To calculate allostatic load for each of the indicators (i.e., hair cortisol, hair dehydroepiandrosterone (DHEA), saliva interleukin-6 (Il-6), hip-to-waist ratio, resting blood pressure, Resting Respiratory Sinus Arrhythmia (RSA), and body mass index percentile), participants who score in the 75th percentile will receive a 1, with the exception of RSA and DHEA, where participants will receive a 1 for scores 25th percentile or below. Participants sores will then be summed. Allostatic load scores then could possible range from 0 -6. Higher scores reflect greater allostatic load. The research team will assess a change in allostatic load at different timepoints. For example, from Baseline to post-assessment, post-assessment to 12-month follow up, and baseline to 12-month follow up.

    Collected at baseline, Post-Assessment (13-weeks), and 12 month follow up

Study Arms (2)

STRIVE

EXPERIMENTAL

Based on the Learning to BREATHE (L2B) curriculum (Broderick, 2013), the STRIVE intervention is a mindfulness-based program designed to facilitate the development of emotion regulation for middle to high school students. Goals of the program include helping students understand their thoughts and feelings, learning how to use mindfulness-based skills to manage emotions, and providing opportunities for guided group mindfulness meditation practice. Delivered in twelve 60-minute group sessions, the intervention will be include the core components of the L2B program (i.e. body awareness; understanding and working with thoughts; understanding and working with feelings; integrating awareness of thoughts, feelings, and bodily sensations; reducing harmful self-judgments, and integrating mindful awareness into daily life) with content framed around the needs of high achieving, college-bound students with the goal of offsetting the costs of resilience.

Behavioral: STRIVE

Study Skills

PLACEBO COMPARATOR

The attention control condition will incorporate face-valid content to support college readiness and achievement in twelve 60- minute group sessions. Twelve sessions will cover the SOAR study skills curriculum (Kruger, 2017), including goal-setting, organization and time-management, and study skills for reading comprehension, writing papers, note-taking, and test-taking.

Behavioral: Study Skills

Interventions

STRIVEBEHAVIORAL

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 activities that illustrate the theme, guided discussion about the activity, and in-session group mindfulness meditation practice.

STRIVE
Study SkillsBEHAVIORAL

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.

Study Skills

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Intellectual Disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

Los Angeles, California, 90049, United States

RECRUITING

Related Publications (3)

  • 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: 35201542BACKGROUND
  • 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: 10450719BACKGROUND
  • 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.

Study Officials

  • Anna S Lau, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna S Lau, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to either the control condition (Study skills) or the experimental condition (STRVE).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Vice Chair

Study Record Dates

First Submitted

March 14, 2023

First Posted

May 6, 2023

Study Start

January 9, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual Participant Data will be shared according to the requirements of the NIMH National Data Archive.

Shared Documents
STUDY PROTOCOL
Time Frame
Data release will align with requirements of the NIMH National Data Archive.

Locations