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
Official title: Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 15
Sex: FEMALE
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An initial evaluation of Little Flower Yoga for Kids will be conducted 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. The overall aim of this study is to ascertain the short and longer-term effects of Little Flower Yoga for Kids, a promising yoga and mindfulness program for children, which incorporates five elements (connect, breathe, move, focus, relax) to improve the child's ability to sustain attention and regulate emotions.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Emotion Regulation Content Scale of the Behavioral Assessment System for Children - 2 (BASC-2)
timeFrame: Nine months from start of the intervention
measure: Tasks of Executive Control (TEC)
timeFrame: Nine months from start of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References: