Not Yet RecruitingNot Applicable

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

United States40 participantsStarted 2024-08-23

Plain-language summary

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.

Who can participate

Age range

4 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Strengths and Difficulties Questionnaire

Timeframe: Pre-intervention and post-intervention (within one week)

Head-Toes-Knees-Shoulders Task

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

Trial details

NCT IDNCT06561373

SponsorElizabethtown College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-11

Contact for this trial

Helen C Russell, doctorate

2078444850 helen.c.c.russell@gmail.com

View on ClinicalTrials.gov More Prosocial Behavior trials