Prosocial BehaviorNCT06561373
Effects of Mindfulness and Yoga on Preschool Students' Emotional Regulation, Behavior, and Social Participation
A study testing Calm & Alert yoga and mindfulness in people with Prosocial Behavior and Self Regulation, run by Elizabethtown College at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosocial Behavior, Self Regulation, Impulsive Behavior
- What is being tested?
- Calm & Alert yoga and mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2024to 11 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Elizabethtown College
Elizabethtown, Pennsylvania, 17022
Nancy Carlson, PhD, 717-361-1174, carlsona@etown.edu
Judy Ericksen, PhD, 717-361-4751, ericksenj@etown.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Prosocial Behavior, Self Regulation, Impulsive Behavior
- Being tested
- Calm & Alert yoga and mindfulness
- Keywords
- mindfulness, children, yoga, preschool, school-based intervention, self-regulation, behavioral incident, occupational therapy
- Medical subject headings
- Altruism, Self-Control, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm & Alert yoga and mindfulnessBehavioural
Also called yoga and mindfulness, mindfulness-based intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
School teachers will track behavioral incidents that fall outside the expected behavior realm for student participants.
Measured: during the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start23 Aug 2024 (estimated)
- Primary completion11 Nov 2024 (estimated)
- Study completion11 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prosocial BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elizabethtown College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Russell, Elizabethtown College
- Investigators
- Helen C Russell, doctorate, Principal investigator, Elizabethtown CollegeElla Longenecker, Bachelor, Study chair, Elizabethtown CollegeSamantha Deiaco, Bachelor, Study chair, Elizabethtown CollegeEllysa Herr, Bachelor, Study chair, Elizabethtown CollegeSarah Lloyd, Bachelor, Study chair, Elizabethtown College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561373
- Sponsor's protocol ID
- 2185448-1
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifying information of the minors that are study participants will not be shared.
Publications
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.
PubMed 32275198Goodman, R. (1997). Strengths and Difficulties Questionnaire (SDQ) [Database record]. APA PsycTests. https://doi.org/10.1037/t00540-000
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.
McGlauflin, H. (2018). Calm & Alert: Yoga and mindfulness practices to teach self-regulation and social skills to children (1st ed.). PESI Publishing & Media.
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.
PubMed 34127901Sciutto 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.
PubMed 33875914
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Intervention: Effects on Emotional Regulation, Behavior, and Social Participation for Preschool Students
- ClinicalTrials.gov ID
- NCT06561373
- Acronym / sponsor ID
- 2185448-1
- Conditions
- Prosocial Behavior, Self Regulation, Impulsive Behavior
- Keywords
- mindfulness, children, yoga, preschool, school-based intervention, self-regulation, behavioral incident, occupational therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Elizabethtown CollegeUniversity, hospital or other
- Study start
- 23 Aug 2024 (estimated)
- Primary completion
- 11 Nov 2024 (estimated)
- Study completion
- 11 Nov 2024 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calm and Alert Mindfulness and Yoga Intervention | Experimental | Behavioral: Calm & Alert yoga and mindfulnessThe 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. |
| 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calm & Alert yoga and mindfulnessAlso: yoga and mindfulness, mindfulness-based interventionThe 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. | Behavioural | Calm and Alert Mindfulness and Yoga Intervention |
Primary outcome
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.
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).
1 secondary outcome
Negative Behavior Incidents
Time frame: during the intervention period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Background: PubMed 32275198Carro 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.
- BackgroundGoodman, R. (1997). Strengths and Difficulties Questionnaire (SDQ) [Database record]. APA PsycTests. https://doi.org/10.1037/t00540-000
- BackgroundMcClelland, 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.
- BackgroundMcGlauflin, H. (2018). Calm & Alert: Yoga and mindfulness practices to teach self-regulation and social skills to children (1st ed.). PESI Publishing & Media.
- Background: PubMed 34127901Rashedi 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.
- Background: PubMed 33875914Sciutto 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.
- Individual participant dataSharing planned: Yes. Identifying information of the minors that are study participants will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen C Russell, doctorate principal investigator
Elizabethtown College
Ella Longenecker, Bachelor study chair
Elizabethtown College
Samantha Deiaco, Bachelor study chair
Elizabethtown College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm & Alert yoga and mindfulness in people with Prosocial Behavior and Self Regulation, run by Elizabethtown College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helen C Russell, doctorate (2078444850, helen.c.c.russell@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire (time frame: Pre-intervention and post-intervention (within one week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561373, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.