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

NCT06561373 | Not Yet Recruiting

• 1 other identifier: 2185448-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosocial Behavior; Self Regulation; Impulsive Behavior

Keywords

mindfulness; children; yoga; preschool; school-based intervention; self-regulation; behavioral incident; occupational therapy

Outcome Measures

Primary Outcomes (2)

• Strengths and Difficulties Questionnaire

  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.

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

• Head-Toes-Knees-Shoulders Task

  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).

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

Secondary Outcomes (1)

• Negative Behavior Incidents

  during the intervention period.

Study Arms (2)

Calm and Alert Mindfulness and Yoga Intervention

EXPERIMENTAL

The Calm \& Alert intervention uses mind, body, and breath to foster resiliency and self-regulation in students. This mindfulness-based intervention, which also incorporates yoga movements, aims to develop skills in self-awareness, self-regulation, safety, focus, attention, active listening, following directions, respect, and positive thinking (McGlauflin, 2018). The program consisted of seven lessons lasting approximately 20-30 minutes, each conducted once a week over seven consecutive weeks.

Behavioral: Calm & Alert yoga and mindfulness

Control Group

NO INTERVENTION

This is a wait-list control group that consists of students in classrooms who will receive business-as-usual programming/instruction during the study period.

Interventions

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.

Also known as: yoga and mindfulness, mindfulness-based intervention

Calm and Alert Mindfulness and Yoga Intervention

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Elizabethtown College: lead

Study Sites (1)

Elizabethtown College

Elizabethtown, Pennsylvania, 17022, United States

Location

Related Publications (6)

• 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.

  PMID: 32275198 BACKGROUND

• Goodman, R. (1997). Strengths and Difficulties Questionnaire (SDQ) [Database record]. APA PsycTests. https://doi.org/10.1037/t00540-000

  BACKGROUND

• 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.

  BACKGROUND

• McGlauflin, H. (2018). Calm & Alert: Yoga and mindfulness practices to teach self-regulation and social skills to children (1st ed.). PESI Publishing & Media.

  BACKGROUND

• 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.

  PMID: 34127901 BACKGROUND

• 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.

  PMID: 33875914 BACKGROUND

MeSH Terms

Conditions

Altruism; Self-Control; Impulsive Behavior

Interventions

Calmodulin; Mindfulness; Yoga

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Intracellular Calcium-Sensing Proteins; Intracellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Calcium-Binding Proteins; Carrier Proteins; Proteins; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Helen C Russell, doctorate

  Elizabethtown College

  PRINCIPAL INVESTIGATOR

• Ella Longenecker, Bachelor

  Elizabethtown College

  STUDY CHAIR

• Samantha Deiaco, Bachelor

  Elizabethtown College

  STUDY CHAIR

• Ellysa Herr, Bachelor

  Elizabethtown College

  STUDY CHAIR

• Sarah Lloyd, Bachelor

  Elizabethtown College

  STUDY CHAIR

Central Study Contacts

Helen C Russell, doctorate

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The secondary researchers will be blinded to which students are in the control and intervention groups until after they have run the statistical analyses.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Helen Russell, pp-OTD

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: August 23, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: anticipated within 6 months of study completion
• Access Criteria: Per request

Locations

US (1)