NCT02829528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 4, 2022

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

July 8, 2016

Last Update Submit

October 31, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Emotion Regulation Content Scale of the Behavioral Assessment System for Children - 2 (BASC-2)

    Measures change in emotion regulation problems at post-treatment

    Nine months from start of the intervention

  • Tasks of Executive Control (TEC)

    Measures change in attentional processing skills at post-treatment

    Nine months from start of the intervention

Study Arms (1)

Little Flower Yoga For Kids

EXPERIMENTAL

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).

Behavioral: Little Flower Yoga For Kids

Interventions

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.

Little Flower Yoga For Kids

Eligibility Criteria

Age5 Years - 7 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University

New York, New York, 10003, United States

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 12, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 4, 2022

Record last verified: 2018-09

Locations