- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02829528
Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention
Study Overview
Detailed Description
The overall aim of this project is to ascertain the effects of Little Flower Yoga for Kids, a promising yoga and mindfulness program for children developed by Jennifer Cohen Harper, MA, E-RCYT, which incorporates five elements (connect, breathe, move, focus, relax) to improve the child's ability to sustain attention and regulate emotions. While research supports that yoga programs and mindfulness programs yield positive outcomes on numerous factors, there are no independent studies presently examining the effects of a combined yoga and mindfulness intervention (like Little Flower Yoga for Kids) on both emotion regulation and sustained attention.
The investigators propose conducting an initial evaluation of Little Flower Yoga for Kids in a small sample of 18-30 Kindergarten and First Grade students (3-5 per class) enrolled in Girls Preparatory Charter School of the Bronx. Little Flower Yoga for Kids is currently part of the curriculum at Girls Preparatory Charter School of the Bronx and implemented by Kelli Love, M.Ed., 500 RYT, received her certification from the Little Flower Yoga for Kids Teacher Training Program. Specifically, the investigators will conduct a preliminary trial with a sample of 5-7 year olds (Kindergarten/First Grade), who meet a predetermined threshold of having either emotional regulation and/or attentional difficulties, to determine the effects of Little Flower Yoga for Kids on sustained attention and emotion regulation. Measures of these outcomes will occur at initial participant screener, baseline, mid-treatment (4.5 months after the start of the program), and post-treatment (after 9 months).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10003
- New York University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
While all students enrolled in kindergarten or first grade at Girls Preparatory Charter School of the Bronx (between the ages of 5-7) will continue to take yoga class (with the Little Flower Yoga program Curriculum) taught by Ms. Keli Love, the investigators will only be collecting data on (at most) 30 of the students. The following inclusion and exclusion criteria will be employed to determine which students will be included in the data collection:
Inclusion Criteria:
- Suspected emotion regulation and/or attention difficulties by the child's teacher. This procedure includes completion (by the teacher) of the Emotion Regulation Checklist (ERC) and the inattention subscale of the Swanson, Nolan, and Pelham - IV (SNAP-IV) (see measures section below). The Kindergarten and First Grade teachers will be asked to identify the top 5 students in their class exhibiting high levels of emotion dysregulation and/or inattention in comparison to their peers, and to then fill out the two assessment measures for each of the 5 selected children. They must meet a predetermined threshold of either measure, which have been determined based on previous research, to be included in the data collection;
- Child must be fluent English speaker, so they are able to complete the assessments.
Exclusion Criteria:
Of the individuals chosen for participation in data collection, they will be excluded from the study if:
- There is evidence of significant developmental delay or psychosis that impacts the child's ability to function and to fully engage in the yoga-mindfulness intervention;
- If the youth or parent presents with emergency psychiatric needs that require services beyond that which can be managed within a preventive intervention format (e.g. hospitalization, specialized placement outside the home), active intervention by research staff to secure what is needed will be made.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Little Flower Yoga For Kids
Little Flower Yoga for Kids is a New York based organization dedicated to making the tools of yoga and mindfulness available to all children and teens.
Their Teacher Training Program focuses on the physical, mental emotional, and social wellbeing of students.
Teachers are trained to use the five elements format (connect, breathe, move, focus, relax).
Implementation of the Little Flower Yoga for Kids curriculum will be manualized prior to the start of the study with Ms. Love, and will be presented as a series of activities (e.g., poses) throughout the school year.
The emphasis in these yoga and mindfulness activities is exploration not competition, which allows the child to learn and develop at her own pace with the support of Ms. Love.
The children participate in the Little Flower Yoga for Kids intervention at school for 40 minutes per class, 3 to 5 times per week, for the entire academic school year (9 months).
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Little Flower Yoga for Kids is a promising yoga and mindfulness program for children developed by Jennifer Cohen Harper, MA, E-RCYT, which incorporates five elements (connect, breathe, move, focus, relax) to improve the child's ability to sustain attention and regulate emotions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Emotion Regulation Content Scale of the Behavioral Assessment System for Children - 2 (BASC-2)
Time Frame: Nine months from start of the intervention
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Measures change in emotion regulation problems at post-treatment
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Nine months from start of the intervention
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Tasks of Executive Control (TEC)
Time Frame: Nine months from start of the intervention
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Measures change in attentional processing skills at post-treatment
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Nine months from start of the intervention
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Little Flower Yoga for Kids
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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