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NCT Number: NCT06561373

Effects of Mindfulness and Yoga on Preschool Students' Emotional Regulation, Behavior, and Social Participation

The goal of this clinical trial is to learn if mindfulness and yoga can improve attention, problem-solving, memory, emotional awareness, and impulsivity in preschoolers. The main questions it aims to answer are:

Can a 30-minute, once-a-week mindfulness and yoga program (Calm & Alert) over seven weeks in preschool classrooms increase emotional regulation during the school day? Can a 30-minute, once-a-week mindfulness and yoga program decrease negative behavioral incidences during the school day? Can a 30-minute, once-a-week mindfulness and yoga program increase prosocial behaviors like caring, sharing, and perspective-taking during the school day? Researchers will compare the effects of students who participated in the mindfulness and yoga program to students in classrooms who did not receive the program. Student participants will be asked to complete a short self-regulation task test before and after the mindfulness program. Teachers will rate the students on their prosocial behavior before and after the mindfulness program and record negative behavioral incidents over the study period.

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Key information

Conditions

Prosocial Behavior Altruism Behavior Impulsive Behavior Self Regulation Self-Control Social Behavior

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The current study design is a quasi-experimental pretest post-study design with a control group. Three schools with a total of four preschool classrooms will participate in this study. Overall, the present research study aims to add to the knowledge base of the benefits of mindfulness and yoga in schools for young children. This will include investigating the effect of mindfulness on children's attention, problem-solving, memory, emotional awareness, and impulsivity. For seven weeks, the intervention group will receive the Calm & Alert mindfulness intervention alongside the rest of their class involving one session per week of about 30 minutes of yoga and mindfulness. The control group will conduct business as usual and receive the yoga and mindfulness intervention after the study concludes. The intervention will be provided by the principal investigator who is a certified mindfulness-informed professional and registered yoga teacher - 200 hours. It is hypothesized that implementing a 30-minute, once-a-week mindfulness program over seven weeks in preschool classrooms will increase emotional regulation, decrease negative behavioral incidents, and increase prosocial behaviors during the school day.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • are preschoolers with a filled out and returned parental/caregiver consent form who fall within the four to six-year-old age range, stay within a similar developmental age range, and attend five out of the seven sessions.

Exclusion criteria

preschoolers without a parental/caregiver consent form, above or below the four to six-year age range will not be included in the study because of the higher variation in developmental capabilities, and if they do not attend five out of the seven sessions.

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Treatment and study plan

Calm & Alert yoga and mindfulness

Behavioral

The Calm & Alert protocol is multisensorial, with successive opportunities to practice the explicit concepts taught throughout the lessons using yoga and mindfulness-techniques. Each class has a similar structure of songs, breathing, warm-ups, yoga poses, mindful games, and rest involving meditation with child-friendly language. The study includes the recommended materials of a Hoberman sphere (breathing ball), chime, mind/body/breath icons, two small mason jars (one with mud and one with clear water), yoga mats for students, pictures of feelings (happy, sad, angry, scared, surprised, disgusted), and an on/off switch.

Other names: yoga and mindfulness, mindfulness-based intervention

Primary outcomes

  1. Strengths and Difficulties Questionnaire

    Time frame: Pre-intervention and post-intervention (within one week)

    The Strengths and Difficulties Questionnaire - Teacher Form (SDQ) is a widely used behavioral screening questionnaire that correlates highly with measures of behavior problems (Goodman & Scott, 1999). The teacher form asks teachers to rate classroom students according to their perceived behavior. It consists of 25 items divided into five scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. For this study, the prosocial behavior subscale will be primarily used for pre- and post-assessment data analysis. The teacher form asks teachers to rate classroom students according to their perceived behavior.

  2. Head-Toes-Knees-Shoulders Task

    Time frame: Pre-intervention and post-intervention (within one week for post and before the start of the study period for pretest)

    The Head-Toes-Knees-Shoulders (HTKS) Task is an ecologically valid method to measure behavioral aspects of self-regulation, such as controlling and directing actions, inhibitory control, paying attention, and recalling instructions (Ponitz, 2008; McClelland and Cameron, 2012). The test is introduced as a game with a gross motor component that more closely aligns with self-regulation behaviors required of children within natural contexts such as the classroom (McClelland and Cameron, 2012).

Secondary outcomes

  1. Negative Behavior Incidents

    Time frame: during the intervention period.

    School teachers will track behavioral incidents that fall outside the expected behavior realm for student participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Helen C Russell, doctorate

CONTACT

[email protected]

2078444850

Sponsors and collaborators

Lead sponsor

Elizabethtown College

Other

Registry information

Official study title

Mindfulness-Based Intervention: Effects on Emotional Regulation, Behavior, and Social Participation for Preschool Students

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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