An interventional study of Calm & Alert yoga and mindfulness in Prosocial Behavior, Self Regulation and Impulsive Behavior, sponsored by Elizabethtown College. Not yet recruiting at 1 site in United States. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Elizabethtown College · Not applicable, Interventional, and Prevention
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.
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.
168 studies on the registry are indexed under Self-Control; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 88 across 144 interventional studies indexed under Self-Control.
Browse Self-Control studies →This is the only study on the registry with Elizabethtown College as lead sponsor.
Compared within Self-Control, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Altruism. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:
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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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
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.
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
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.
Time frame: 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).
Time frame: Pre-intervention and post-intervention (within one week for post and before the start of the study period for pretest)
Negative Behavior Incidents
School teachers will track behavioral incidents that fall outside the expected behavior realm for student participants.
Time frame: during the intervention period.
Plan to share: Yes — Identifying information of the minors that are study participants will not be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: anticipated within 6 months of study completion
Access criteria: Per request
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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