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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This pilot project will evaluate yoga as an intervention to improve attention and reduce challenging behaviors such as hyperactivity and impulsivity, rated by parent and teachers, in preschool age children with or "at risk" for attention-deficit hyperactivity disorder (ADHD). "At Risk" for ADHD will be defined as four or more hyperactive/impulsive and/or inattentive symptoms on the ADHD Rating Scale IV-Preschool Version as rated by parents or teachers. Using a randomized wait-list controlled experimental design, the investigators will explore the efficacy of practicing yoga for 6 weeks on behavioral symptoms, attentional control using a computer based tasks of attention, and heart rate variability (HRV), which is a measure of self-regulatory capacity. The investigators hypothesize that practicing yoga for six weeks of will improve ADHD and other behavioral symptoms based on parent and teacher rating scales, which will correlate with improvements in scores on the computer based task of attention as well as with improvements in HRV.

Condition or disease Intervention/treatment
ADHD Behavioral: Children's Yoga

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Yoga on Attention, Impulsivity and Hyperactivity in Pre-school Age Children With ADHD Symptoms
Study Start Date : December 2015
Primary Completion Date : March 2016
Study Completion Date : August 2016
Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English speaking children
  • Ages of 3-5 years old
  • Diagnosed with ADHD or "at risk" for ADHD (defined as four or more hyperactive/impulsive and/or inattentive symptoms on the ADHD Rating Scale IV-Preschool Version rated by parents or teachers)

    • The yoga intervention will be given in addition to any other behavioral and/or medication treatments that the study participants are receiving. We will document any medications or behavioral therapies that participants are on during the study.
  • The child's parent agrees to support their child in doing home yoga practice using a yoga video, which may range from being present and giving verbal encouragement to their child but not engaging in the yoga themselves (which is recommended and preferred for pregnant women) to practicing yoga along with their child using the yoga videos based on the parent's preference and comfort level with practicing yoga.
  • Children with common co-morbid diagnoses such as autism spectrum disorder, anxiety, oppositional defiant disorder, and learning differences.
  • Children's parents and teachers (including pregnant women if applicable) will be included in the study, as they will be asked to complete study questionnaires and surveys.

Exclusion Criteria:

  • Non-English speaking children
  • Children who have a medical condition or physical impairment precluding them from safely exercising and participating in the yoga classes (eg. spastic quadriplegic cerebral palsy, critical congenital heart disease, uncontrolled asthma, uncontrolled seizure disorder, etc.).
  • Adults unable to consent
  • Children younger than 3 or older than 5 at the start of the study intervention
  • Prisoners
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, California
Triumph Center for Early Childhood Education
Sacramento, California, United States, 95820
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Samantha C Cohen, MD University of California, Davis
More Information

Publications:
Barkley RA. Attention-Deficit Hyperactivity Disorder. Fourth Edition ed. Barkley RA, editor. New York, NY: The Guilford Press; 2015.
Peck HL, Kehle TJ, Bray MA, Theodore LA. Yoga as an Intervention for Children With Attention Problems. School Psychology Review. 2005;34(3):415.
Harrison LJ. Sahaja Yoga Meditation as a Family Treatment Program for Children with Attention Deficit-Hyperactivity Disorder. Clinical Child Psychology and Psychiatry. 2004; 9(4):479-97.

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02642666     History of Changes
Other Study ID Numbers: 801230
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participants data will be de-identified and analyzed as a group.

Keywords provided by University of California, Davis:
Attention
Hyperactivity
Impulsivity
Yoga
Preschool

Additional relevant MeSH terms:
Hyperkinesis
Impulsive Behavior
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms