Clinical trial NCT06014970: The Health and Wellness Curriculum Assessment
Official title: The Health and Wellness Curriculum Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma, Psychological
Stress, Psychological
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Pure Edge Inc.
name: University of San Diego
name: University of South Carolina
name: Iowa State University
First posted: 2023-08-28
Enrollment: 1176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overarching goal of the study is to examine the effects of a new Health and Wellness Curriculum (Pure Power) being implemented in the Ravenswood City School District in East Palo Alto. The Pure Power Curriculum, which the Sonima Foundation (Now Pure Edge Inc.,)developed, includes exercise based on yoga, common exercise regimes, relaxation techniques, mindfulness practices, and nutrition education, and was introduced in 2014 to the Ravenswood City Schools, independent of the research. The new curriculum was expected to yield dramatic positive effects on students' socio-emotional development, which the investigators aimed to examine through this study.

This research evaluation measures the impact of the Pure Power Curriculum on the socioemotional, behavioral, cognitive, academic, and physiological functioning of students in a low-socioeconomic status (SES) school community over time by evaluating student development at three time points: baseline (i.e., prior to implementation of the curriculum), one-year follow-up, and two-year follow-up. Only third and fifth-grade students were eligible for enrollment at baseline. All data collection procedures were replicated with the control group.

Detailed description: Participants for the experimental group were recruited from the Ravenswood City School District.

Trained instructors provided the Health and Wellness Curriculum at the Ravenswood City schools. Each school receiving the curriculum had a dedicated space and received a 30-minute class twice a week. Through group discussion, nutrition and character education, and breathing exercises, students received instruction to focus their attention, calm their minds, reduce stress, and think before reacting.

Control subjects were recruited from Orchard School District, Alum Rock Union Elementary School District, and nearby community organizations/ after-school programs (like Boys and Girls Clubs) in the San Francisco Bay Area. The control group was recruited after the experimental group had finished baseline data collection.

At three separate points over the course of three years, all consenting participants received academic and neurobehavioral assessments via paper questionnaires in the classroom. The research staff measured children's academic functioning abilities and moods, thoughts, and behavioral symptoms, which were employed as a control variable in the proposed analyses. This was accomplished by administering the Wide Range Achievement Test (WRAT IV), the Behavior Assessment System for Children (BASC-II), the Responses to Stress Questionnaire, and the Behavior Rating Inventory of Executive Function (BRIEF).

At Ravenswood, at least 100 students from the original 800-student sample were recruited for the cognitive (plus additional questionnaires), sleep, and endocrinology portions of the study. From this 100-student sub-sample, at least 30 students were recruited to participate in the neuroimaging component of the study. Cognitive abilities were assessed using the Kaufman Assessment Battery for Children 2 (K-ABC II): all scales and subtests. During the cognitive testing portion of the study, participants also completed the reading section of the Wide Range Achievement Test (WRAT-IV) and the Trauma Symptoms Checklist for Children (TSCC).

This project was the first systematic neuroscience study of skill-building in children via a multi-method assessment that includes structural MRI, functional MRI, salivary cortisol, and sleep architecture data. These are methods that have proven critical in the fundamental understanding of stress in children. The research will identify critical biopsychosocial components responsible for cognitive, behavioral, emotional, and academic improvement, effective implementation, and the sustainability of the program.

Diurnal salivary cortisol was collected by parents using the Salimetrics Children's Swab for 2 consecutive days at five specific times: within 20 minutes of waking up, before breakfast, before lunch, before dinner and before bedtime. Results from these time periods will serve as an index of baseline cortisol rhythmicity. This process occurred a total of three times (once at each assessment time).

fMRI: Children completed the Tanner stages form to assess their scale of physical development (puberty) and handedness form to determine if they are right or left-handed and the Domain-Specific Impulsivity Scale for Children (DSIS-C) questionnaire, which measures impulsivity traits in the domains of schoolwork and interpersonal relationships, to be used in concert with neuroimaging data. fMRI, DTI and sMRI data will be acquired on a 3T scanner with a state-of-the-art 32-channel parallel imaging coil. Children will perform up to four cognitive and emotional experiments during fMRI scanning:

* A stop signal task investigated brain plasticity in systems associated with attention and cognitive control.
* An emotional labeling task was used to examine brain plasticity in systems associated with emotion perception.

Data for each experiment was acquired across 2 runs (except only 1 run for the emotional labeling task), each lasting 6 minutes, in order to minimize fatigue while providing adequate statistical power to detect effects of interest. This process will occur a total of three times (once at each assessment time). Participants will also complete a Delay Discounting Task outside of the MRI scanner.

Two salivary cortisol samples were collected by researchers: one at the beginning of the scan and the other one after the scan. One salivary hormone sample was collected at the end of the scan.

To assess sleep, researchers conducted the overnight ambulatory polysomnography (PSG) of sleep.

Eligibility criteria: Inclusion Criteria:

* All 3rd and 5th-grade students in the participating school districts

Exclusion Criteria:

* For fMRI:

  1. History of trauma involving head injury.
  2. Metal in or on the body that cannot be removed(braces, piercings or tattoos).
  3. Consistent exposure to metal(i.e. hobbies grinding metal).
  4. Pregnancy.
  5. Left-handedness.
  6. Any tattoos on the body, including eyeliner and other permanent makeup.
* For general study: Students who demonstrate the inability to follow all study procedures during a specific assessment will be excluded from that portion of the study.

Primary outcomes:
measure: Mean Change in Response to Stress Questionnaire
timeFrame: Three time points: Baseline, 12 months, 24 months
measure: Mean Change in School Achievement
timeFrame: Three time points: Baseline, 12 months, 24 months
measure: Mean Change in Emotional and Behavioral Dysregulation
timeFrame: Three time points: Baseline, 12 months, 24 months
measure: Change from Baseline of Diurnal Salivary Cortisol
timeFrame: Three time points: Baseline, 12 months, 24 months
measure: Change from Baseline of Sleep Quality
timeFrame: Three time points: Baseline, 12 months, 24 months
measure: Change from Baseline of Sleep Habits
timeFrame: Three time points: Baseline, 12 months, 24 months
measure: Measure of Brain Plasticity for Attention and Cognitive Control
timeFrame: Three time points: Baseline, 12 months, 24 months
measure: Measure of Brain Plasticity for Risk Taking and Risk Avoidance
timeFrame: Three time points: Baseline, 12 months, 24 months
measure: Measure of Brain Plasticity for Emotion Perception
timeFrame: Three time points: Baseline, 12 months, 24 months
measure: Measure of Brain Plasticity for Emotional Control
timeFrame: Three time points: Baseline, 12 months, 24 months
Secondary outcomes:
measure: Overall Cognitive Assessment
timeFrame: Three time points: Baseline, 12 months, 24 months
Other outcomes:
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