ADHDNCT02829528
Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention
A study testing Little Flower Yoga For Kids in people with ADHD, run by New York University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 7 years, women only
- Conditions the study is for
- ADHD
- What is being tested?
- Little Flower Yoga For Kids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jun 2017
- 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 5 to 7 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- ADHD
- Being tested
- Little Flower Yoga For Kids
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Little Flower Yoga For KidsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Little Flower Yoga For Kids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Regulation Content Scale of the Behavioral Assessment System for Children - 2 (BASC-2)
Measures change in emotion regulation problems at post-treatment
Measured: Nine months from start of the intervention
Tasks of Executive Control (TEC)
Measures change in attentional processing skills at post-treatment
Measured: Nine months from start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829528
- Sponsor's protocol ID
- Little Flower Yoga for Kids
- Status last verified
- Sep 2018
- First submitted
- 8 Jul 2016
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Little Flower Yoga for Kids: Evaluation of a Yoga and Mindfulness Program for Children With Increased Levels of Emotion Dysregulation and Inattention
- ClinicalTrials.gov ID
- NCT02829528
- Acronym / sponsor ID
- Little Flower Yoga for Kids
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Little Flower Yoga For Kids | Experimental | Behavioral: Little Flower Yoga For KidsLittle 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). |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Little Flower Yoga For KidsLittle 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. | Behavioural | Little Flower Yoga For Kids |
Primary outcome
Emotion Regulation Content Scale of the Behavioral Assessment System for Children - 2 (BASC-2)
Time frame: Nine months from start of the intervention
Measures change in emotion regulation problems at post-treatment
Tasks of Executive Control (TEC)
Time frame: Nine months from start of the intervention
Measures change in attentional processing skills at post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Description: Families and Children Experiencing Success (FACES) LabLink provided by the sponsor.
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Little Flower Yoga For Kids in people with ADHD, run by New York University 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 4 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Content Scale of the Behavioral Assessment System for Children - 2 (BASC-2) (time frame: Nine months from start of the intervention). 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?
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 4 Nov 2022.