Clinical trial NCT03412162: Biology, Identity & Opportunity Study
Official title: Race-based Biological Stress, Ethnic-Racial Identity, and Educational Outcomes: New Approaches to Studying Academic Achievement Gaps
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress, Psychological
Stress, Emotional
Stress, Physiological
Keywords: Discrimination
Cortisol
Sleep
Identity
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Harvard University
First posted: 2018-01-26
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two conditions will be tested: an ethnic-racial identity promotion intervention, and academic skills promotion control condition.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will implement an intervention designed to promote ethnic and racial identity development. It is hypothesized that the intervention will have positive effects on ethnic-racial identity development, stress biology (including sleep hours and quality and diurnal cortisol profiles), emotional well-being, executive functioning, and academic outcomes, particularly for minority youth.

Detailed description: On average, students from disadvantaged racial-ethnic minority groups (such as Blacks and Hispanics) show lower academic performance and attainment on a variety of measures, including grades, test scores and graduation rates. Racial-ethnic minority students are also exposed to higher levels of stress, especially "race-based stress," including higher levels of discrimination and stereotype threat. Past research has shown that race-based stress is related to alterations in stress biology, including altered stress hormone levels and less and lower quality sleep. Altered stress hormones and shorter and lower quality sleep in turn have important implications for multiple aspects of cognitive functioning, including executive functioning, that have known impacts on emotional well-being and academic performance.

It is therefore hypothesized that disparities in race-based stress and stress biology may help to account for racial-ethnic disparities in academic performance. One (correlational, non-causal) purpose of this study, therefore, is to measure and test associations among race-based social stress (RBSS, such as perceived racial discrimination), stress biology (cortisol daily rhythms and sleep hours and quality) and academic outcomes in 300 high school students in a racially diverse, mid-sized, suburban high school.

Additional research has shown that the presence of a strong ethnic-racial identity is associated with better-regulated stress biology and higher academic attainment. A second major purpose of this study, and the primary purpose of this RCT, is to test, through a random-assignment intervention, whether promoting positive ethnic and racial identity development serves to advance ethnic and racial identity development, improve stress biology, and improve emotional well-being, cognition (executive functioning), and academic outcomes. Positive effects on these outcomes are expected for those in the experimental (ethnic and racial identity promotion) group, compared to the comparison group. Effects are expected to be particularly strong for those in the experimental condition that are from black and hispanic ethnic and racial minority groups.

The present study will assess race-based social stress (received racial discrimination and stereotype threat susceptibility), ethnic and racial identity, cortisol, sleep, cognition (executive functioning), emotional and academic adjustment, and academic outcomes in a cohort of 300 high school freshman both before and after an 8-week randomized control trial of the Identity Project Intervention (Umaña-Taylor \& Douglass, 2017; Umaña-Taylor, Douglass, Updegraff \& Marsiglia, 2017). Participants will be recruited in 2 or (if necessary) 3 annual waves, with baseline data collection for the study starting on December 16, 2017. Initial tests of the RCT effects will occur immediately after the intervention and in the year subsequent to the intervention. Questionnaire and administrative outcomes will continue to be measured through the senior year of high school. Additional funding will be sought to measure physical health outcomes, and to follow participants into their college and/or work years. Study plans and hypotheses for these follow-on studies will be registered separately.

Eligibility criteria: Inclusion Criteria:

-Three hundred students will be recruited through announcements and presentations in required, non-tracked 9th grade classes at 3 mid-sized, diverse, suburban high schools, through flyers posted around the school, and through e-mails sent and presentations made to students and parent groups.

Exclusion Criteria:

* The presence of an endocrine disorder or use of corticosteroid based medications.
* Youth who are unable to read in English will be excluded because materials will solely be available in English.
* The study will not include students who do not provide parental consent.
* The study will not include students who do not provide their own assent
* The study will not include pregnant students in this study.

Primary outcomes:
measure: Ethnic and Racial Identity (ERI) development: Total Score
timeFrame: Within 1 month following the 8-week intervention.
measure: Ethnic and Racial Identity (ERI) development: Pride/Affirmation
timeFrame: Within 1 month following the 8-week intervention.
measure: Ethnic and Racial Identity (ERI) development: Exploration
timeFrame: Within 1 month following the 8-week intervention.
measure: Ethnic and Racial Identity (ERI) development: Resolution
timeFrame: Within 1 month following the 8-week intervention.
measure: Ethnic and Racial Identity (ERI) development: Centrality
timeFrame: Within 1 month following the 8 week intervention
measure: Ethnic and Racial Identity (ERI) development: Total Score
timeFrame: Between 9 and 12 months following the 8-week intervention.
measure: Ethnic and Racial Identity (ERI) development: Pride/Affirmation
timeFrame: Between 9 and 12 months following the 8-week intervention.
measure: Ethnic and Racial Identity (ERI) development: Exploration
timeFrame: Between 9 and 12 months following the 8-week intervention.
measure: Ethnic and Racial Identity (ERI) development: Resolution
timeFrame: Between 9 and 12 months following the 8-week intervention.
measure: Ethnic and Racial Identity (ERI) development: Centrality
timeFrame: Between 9 and 12 months following the 8-week intervention.
Secondary outcomes:
measure: Student Emotional Well-being: Student Self-Esteem
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Student Emotional Well-being: Symptoms of Depression total score
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Student Emotional Well-being: Symptoms of Depression- Somatic Symptoms
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Student Emotional Well-being: Symptoms of Depression- Negative Affect
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Student Emotional Well-being: Symptoms of Depression- Positive Affect
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Student Emotional Well-being: Symptoms of Depression- Interpersonal Problems
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Student Emotional Well-being: Adolescent internalizing and externalizing total problems
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Student Emotional Well-being: Adolescent externalizing total problems
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Student Emotional Well-being: Adolescent internalizing total problems
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Overall academic engagement
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Academic engagement: behavioral engagement
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: School belonging
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Academic motivation
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Academic Efficacy
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Academic achievement and attainment: Standardized achievement tests
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Academic achievement and attainment: Student grades
timeFrame: Assessed at the end of the academic year following completion of the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Global Executive Composite
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Behavioral Regulation Index
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Metacognition Index
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Inhibit scale
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Shift scale
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Emotional Control scale
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Initiate scale
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Working Memory scale
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Plan/Organize scale
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Organization of Materials scale
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Self-Reported Executive functioning- Monitor scale
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Executive functioning- Cognitive Flexibility and Set Switching TMT-B
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Executive functioning- TMT-B total error count
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Executive functioning- TMT-B set-shifting error count
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Executive functioning- TMT-B sequencing error count
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Executive functioning- Cognitive Flexibility and Set Switching without basic processing speed
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Executive functioning- Basic processing speed
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Executive functioning, NIH Toolbox Dimensional Change Card Sort Test
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Attention, NIH Toolbox Flanker Inhibitory Control and Attention Test.
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Episodic Memory, NIH Toolbox Picture Sequence Memory Test
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Processing Speed, NIH Toolbox Pattern Comparison Processing Speed Test
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Working Memory, NIH Toolbox List Sorting Working Memory Test
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Cognition: Fluid Intelligence
timeFrame: Measured within 1 year of completing the 8 week intervention and control curricula.
measure: Actigraphy Hours of Sleep
timeFrame: Measured within 1 year after completing the 8 week intervention and control curricula.
measure: Actigraphy Sleep Efficiency
timeFrame: Measured within 1 year after completing the 8 week intervention and control curricula.
measure: Actigraphy Sleep Latency
timeFrame: Measured within 1 year after completing the 8 week intervention and control curricula.
measure: Cortisol: Diurnal Cortisol Slope
timeFrame: Measured within 1 year after completing the 8 week intervention and control curricula.
measure: Cortisol: Cortisol awakening response.
timeFrame: Measured within 1 year after completing the 8 week intervention and control curricula.
measure: Cortisol: Average cortisol level.
timeFrame: Measured within 1 year after completing the 8 week intervention and control curricula.
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Beacon Academy
state: Illinois
city: Evanston
country: United States
facility: District 202
state: Illinois
city: Niles
country: United States
facility: District 219 Niles Township High Schools
state: Illinois
Study officials:
affiliation: Northwestern University
name: Emma K Adam, PhD
role: PRINCIPAL_INVESTIGATOR
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