Clinical trial NCT06561373: Effects of Mindfulness and Yoga on Preschool Students' Emotional Regulation, Behavior, and Social Participation
Official title: Mindfulness-Based Intervention: Effects on Emotional Regulation, Behavior, and Social Participation for Preschool Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prosocial Behavior
Self Regulation
Impulsive Behavior
Keywords: mindfulness
children
yoga
preschool
school-based intervention
self-regulation
behavioral incident
occupational therapy
Lead sponsor: Elizabethtown College
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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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Primary outcomes:
measure: Strengths and Difficulties Questionnaire
timeFrame: Pre-intervention and post-intervention (within one week)
measure: 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)
Secondary outcomes:
measure: Negative Behavior Incidents
timeFrame: during the intervention period.
Other outcomes:
Locations:
city: Elizabethtown
country: United States
facility: Elizabethtown College
state: Pennsylvania
Study officials:
affiliation: Elizabethtown College
name: Helen C Russell, doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: Elizabethtown College
name: Ella Longenecker, Bachelor
role: STUDY_CHAIR
affiliation: Elizabethtown College
name: Samantha Deiaco, Bachelor
role: STUDY_CHAIR
affiliation: Elizabethtown College
name: Ellysa Herr, Bachelor
role: STUDY_CHAIR
affiliation: Elizabethtown College
name: Sarah Lloyd, Bachelor
role: STUDY_CHAIR
References:
citation: Carro N, D'Adamo P, Lozada M. A School Intervention Helps Decrease Daily Stress While Enhancing Social Integration in Children. Behav Med. 2021 Jul-Sep;47(3):251-258. doi: 10.1080/08964289.2020.1738319. Epub 2020 Apr 10.
citation: Goodman, R. (1997). Strengths and Difficulties Questionnaire (SDQ) [Database record]. APA PsycTests. https://doi.org/10.1037/t00540-000
citation: McClelland, M. M., Cameron, C., Bowles, R., & Geldhof, G. (2018). Developing a measure of self-regulation for at-risk children. U.S. Department of Education, Institute for Education Sciences.
citation: McGlauflin, H. (2018). Calm & Alert: Yoga and mindfulness practices to teach self-regulation and social skills to children (1st ed.). PESI Publishing & Media.
citation: Rashedi RN, Rowe SE, Thompson RA, Solari EJ, Schonert-Reichl KA. A Yoga Intervention for Young Children: Self-Regulation and Emotion Regulation. J Child Fam Stud. 2021;30(8):2028-2041. doi: 10.1007/s10826-021-01992-6. Epub 2021 Jun 9.
citation: Sciutto MJ, Veres DA, Marinstein TL, Bailey BF, Cehelyk SK. Effects of a School-Based Mindfulness Program for Young Children. J Child Fam Stud. 2021;30(6):1516-1527. doi: 10.1007/s10826-021-01955-x. Epub 2021 Apr 15.