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

August 16, 2024 updated by: Helen Russell, Elizabethtown College

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Elizabethtown, Pennsylvania, United States, 17022
        • Elizabethtown College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Helen Russell, pp-OTD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calm and Alert Mindfulness and Yoga Intervention
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
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
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention and post-intervention (within one week)
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).
Pre-intervention and post-intervention (within one week for post and before the start of the study period for pretest)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabethtown College

Investigators

  • Principal Investigator: Helen C Russell, doctorate, Elizabethtown College
  • Study Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 23, 2024

Primary Completion (Estimated)

November 11, 2024

Study Completion (Estimated)

November 11, 2024

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 16, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2185448-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Identifying information of the minors that are study participants will not be shared.

IPD Sharing Time Frame

anticipated within 6 months of study completion

IPD Sharing Access Criteria

Per request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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