The Effects of Yoga on Attention, Impulsivity and Hyperactivity in Pre-school Age Children
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|ClinicalTrials.gov Identifier: NCT02642666|
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Behavioral: Children's Yoga||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Yoga on Attention, Impulsivity and Hyperactivity in Pre-school Age Children With ADHD Symptoms|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Yoga intervention
While in the yoga intervention arm of the study participants will practice yoga at home and at school for six weeks with the goal of practicing yoga daily during that time period. Yoga classes will be held twice a week at school. On the days that the children do not practice yoga at school, they will practice yoga at home with the use of a children's yoga video that mirrors the yoga class that they attend at school.
Behavioral: Children's Yoga
Trained children's yoga instructors will guide the children through 30 minute yoga classes (in-person and on the yoga video), using a manualized curriculum from If I Was a Bird Yoga ™ with child centered themes. Each class will have a similar structure, set of poses, and breathing exercises, but the theme of the class will change every two weeks. The themes for the classes are "ocean yoga adventure", "jungle yoga adventure" and "outer space yoga adventure". The study participants will spend two weeks practicing the same theme at home and at school before moving on to the next theme.
No Intervention: Normal school and home activities
While in the wait-list group the children will continue with their regular activities both at home and at school.
- Change in ADHD Rating Scale-IV Preschool Version Scores [ Time Frame: Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up ]An 18 item questionnaire with reliable, valid and developmentally appropriate statements based on ADHD symptoms defined by the Diagnostic and Statistical Manual (DSM)-IV-Text Revision. Parents and teachers will be asked to rate the frequency of the behaviors listed. It will be used for screening and monitoring response to the intervention.
- Change in Strengths and Difficulties Questionnaire Scores [ Time Frame: Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up ]A 30 item questionnaire validated with five sub-scales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention Symptoms, Peer Problems and Pro-social Behaviors. There is a total difficulty score, and a pro-social scale score. Both parents and teachers will be asked to complete this questionnaire. It will be used for screening and monitoring response to the intervention.
- Change in KiTAP Test of Attentional Performance for Children Scores [ Time Frame: Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up ]The KiTAP is a computer administered child-friendly test with the theme of an enchanted castle. Four of the 8 sub-tests (alertness, distractibility, flexibility, and go/no-go) are feasible and reliable for a mental age of 3 years and higher, and correlated with behavioral ratings of hyperactivity and attention. The investigators will collect percent correct and response time on the 4 sub-tests to assess attention and executive function.
- Change in Heart rate variability (HRV) [ Time Frame: Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up ]HRV will be measures using the emWave® Coherence System by HeartMath. The emWave®, which is a commercially available device, is a photoplethysmography optical sensor (similar to a pulse ox) that will be placed on the subjects earlobe to measure the beat-to-beat changes in heart rate, which constitutes HRV. A computer program interprets the inter-beat-intervals into a spectral display of the heart rhythm patterns. HRV will be measured during the KiTAP test of attention/executive function and during a yogic breathing exercise paired with verbal affirmations.
- Change in Likert scale of "Time on Task" during group yoga classes [ Time Frame: During the six week intervention, after the school based yoga classes ]A seven point Likert scale rated by the yoga instructor will be completed for each study participant after each school based yoga class.
- Change in Strategies Used to Address Challenging Behaviors [ Time Frame: Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up ]A three item questionnaire for parents and teachers about the strategies they use to address challenging behaviors in their child or student. For each strategy they use they are asked to rate how well it works on a semantic differential scale from "Ineffective" to "Very effective", and if their child/student is receptive to using the strategy.
- Parent and Teacher Satisfaction Questionnaire [ Time Frame: After 6 to 12 weeks ]A 7 to 9 item questionnaire to assess the feasibility of the intervention by assessing parent and teacher satisfaction with the intervention and their perception about how challenging it was to implement.
- Parent and Teacher Perception Questionnaire [ Time Frame: After 6 to 12 weeks ]A 12-14 item questionnaire to assess parent and teacher perceptions about such things as the usefulness of the yoga breathing exercises, details about the children's behavior not addressed in the rating scales, ease of use of the yoga video for parents, and duration of effects after practicing yoga.
- Feasibility [ Time Frame: Through study completion, an average of 18 weeks ]The investigators will assess the feasibility of the intervention by assessing drop-out rates.
- Qualitative Data About the Feasibility of the Yoga Intervention Using Focus Group Discussions with Parents and Teachers [ Time Frame: After 6 to 12 weeks ]Parents and teachers will be invited to participate in a focus group discussion about their perception of their child's/student's experience during the yoga intervention. The parent and teacher focus groups will be held separately and consist of 4 to 6 questions that will take about 20-30 minutes to discuss. The discussions will be record, and then transcribed and coded. The focus group questions will help to gain detailed qualitative data about parent and teacher perceptions about such things as the usefulness of the yoga breathing exercises, descriptions of the changes in children's behavior that were noticed during the yoga intervention (included any changes in sleep, appetite and overall behavior), how long the effects of practicing yoga seemed to last, ease of use of the yoga video for parents, and effects on parent and teacher stress levels during the yoga intervention.
- Measure of Adherence with Home Yoga Practice [ Time Frame: Through study completion, an average of 18 weeks ]The investigators will assess the number of home based sessions each child participated in to assess adherence with the program. Home based yoga sessions will be tracked in REDCap using parent's responses to the daily emails they receive. For parents who don't have easy access to email a hard copy of the Daily Survey to Assess Frequency of Yoga Practice will be sent home for parents to complete each week.
- Measure of Adherence with School Yoga Practice [ Time Frame: Through study completion, an average of 18 weeks ]The investigators will assess the number of school based sessions each child participated in to assess adherence with the program. Attendance at school based yoga session will be tracked by the yoga instructors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642666
|United States, California|
|Triumph Center for Early Childhood Education|
|Sacramento, California, United States, 95820|
|Principal Investigator:||Samantha C Cohen, MD||University of California, Davis|