The Health and Wellness Curriculum Assessment

NCT06014970 | Completed

• 1 other identifier: IRB-31715
• Study Type: interventional
• Target: 1,176
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Trauma, Psychological; Stress, Psychological

Outcome Measures

Primary Outcomes (10)

• Mean Change in Response to Stress Questionnaire

  The Response to Stress Questionnaire (RSQ) is comprised of a checklist of stressors that may be experienced during stressful situations. Following the checklist of stressors, a possible total of 57 questions ask individuals how they respond to stressors they recently experienced. Youth rate how often they cope with a stressor in a certain way on a 4-point Likert scale (ranging from 1, "Not at all," to 4, "A lot"). The RSQ is divided into two major subscales: School-Related Stress Experiences and Stress Reactivity. Stress Reactivity is further divided into two composite scores: involuntary engagement and primary control. To score the RSQ, proportion scores are created for each factor to control for individual differences in rates of endorsing items. Changes in scores will be assessed between all time points.

  Three time points: Baseline, 12 months, 24 months

• Mean Change in School Achievement

  School achievement was assessed with the Wide Range Achievement Test-Revised Spelling and Math scale score. The spelling subscale was a phonetic test that assessed the degree to which students could encode sounds into written words. The math computation subscale measured students' ability to identify numbers, count, and solve written computational problems. The scores are summed across the subscales and scaled according to the standardized score. A higher score reflects a higher performance. Changes in scores will be assessed between all time points.

  Three time points: Baseline, 12 months, 24 months

• Mean Change in Emotional and Behavioral Dysregulation

  Internalizing symptoms (i.e. anxiety and depression) and externalizing problems (i.e. attention and hyperactivity) were assessed via a self-report version of the Behavior Assessment System for Children, 2nd edition (BASC-II). For items 1-69, participants were asked to respond True or False to a series of statements about themselves. For items 70-176 participants were asked to respond Never, Sometimes, Often, or Almost Always to a series of statements about themselves. Responses were scored via the BASC-II formulas for subscale t-scores, percentiles, and validity scores. Changes in scores will be assessed between all time points.

  Three time points: Baseline, 12 months, 24 months

• Change from Baseline of Diurnal Salivary Cortisol

  Diurnal salivary cortisol were collected by parents using the Salimetrics Children's Swab for 2 consecutive days at five specific times. Results from these time periods will serve as an index of baseline cortisol rhythmicity. This process will occur a total of three times (once at each assessment time).

  Three time points: Baseline, 12 months, 24 months

• Change from Baseline of Sleep Quality

  Research staff employed the Compumedics Safiroambulatory Polysomnography monitoring system to assess sleep. This ambulatory device includes a cap and several electrodes, and records electroencephalogram (EEG), Electromyography (EMG), expiratory/inspiratory nasal airway pressure, nasal/oral airflow, finger pulse oximetry, electrocardiogram (ECG), movements of the rib cage and abdomen, snoring, body position and bilateral anterior tibialis EMG.

  Three time points: Baseline, 12 months, 24 months

• Change from Baseline of Sleep Habits

  Parents complete the abbreviated Child's Sleep Habits Questionnaire (CSHQ). Parents are asked to recall sleep behaviors occurring over a "typical" recent week. Items are rated on a three-point scale: "usually" if the sleep behavior occurred five to seven times/week; "sometimes" for two to four times/week; and "rarely" for zero to one time/week. Some items were reversed in order to consistently make a higher score indicative of more disturbed sleep. This process will occur a total of three times (once at each assessment time).

  Three time points: Baseline, 12 months, 24 months

• Measure of Brain Plasticity for Attention and Cognitive Control

  fMRI task: A stop signal task was used to investigate brain plasticity in systems associated with attention and cognitive control. In stop signal task, participants made button presses in response to left/right-pointing arrows and occasionally cancel their prepared responses. Data for each experiment will be 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).

  Three time points: Baseline, 12 months, 24 months

• Measure of Brain Plasticity for Risk Taking and Risk Avoidance

  fMRI task: A balloon analogue risk task (BART) will be used to investigate brain plasticity in systems associated with risk-taking and risk avoidance. In BART, participants choose between pumping a balloon or to cash out on each trial. Every successful pump adds to their reward on that trial. If the balloon explodes, the accumulated earning on that trial will be lost.

  Three time points: Baseline, 12 months, 24 months

• Measure of Brain Plasticity for Emotion Perception

  fMRI task: Participants will decide which of two facial expressions presented on the bottom of the screen match the facial expression at the top of the screen. The faces have either angry or fearful expression.

  Three time points: Baseline, 12 months, 24 months

• Measure of Brain Plasticity for Emotional Control

  fMRI task: Participants viewed 60 neutral and aversive images which are carefully selected for pediatric populations based on previous studies. When participants see the instructional cue "Look", participants naturally react to the picture. When participants see the cue "Decrease", participants tell themselves a story about the picture to feel less negative (i.e., to reappraise). Prior to the fMRI experiment, children will be given examples about how to reappraise (e.g., imagining it is just a scene from a movie) and asked to report the reappraisals aloud during training to ensure understanding of the instructions.

  Three time points: Baseline, 12 months, 24 months

Secondary Outcomes (1)

• Overall Cognitive Assessment

  Three time points: Baseline, 12 months, 24 months

Study Arms (2)

Health and Wellness Curriculum

EXPERIMENTAL

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

Behavioral: Health and Wellness Curriculum

Control

NO INTERVENTION

All control participants go through the same assessment procedures as the experimental group without any intervention.

Interventions

Health and Wellness Curriculum BEHAVIORAL

The curriculum includes instructions, activities, and lessons on mindfulness, neurobiology, meditation, positive thinking, movement, and nutrition.

Health and Wellness Curriculum

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• For fMRI:
• History of trauma involving head injury.
• Metal in or on the body that cannot be removed(braces, piercings or tattoos).
• Consistent exposure to metal(i.e. hobbies grinding metal).
• Pregnancy.
• Left-handedness.
• 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.

Sponsors & Collaborators

• Victor Carrion: lead
• Pure Edge Inc.: collaborator
• University of San Diego: collaborator
• University of South Carolina: collaborator
• Iowa State University: collaborator

MeSH Terms

Conditions

Psychological Trauma; Stress, Psychological

Interventions

Health

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Vice-Chair of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 28, 2023
• Study Start: September 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 28, 2023

Record last verified: 2023-08