The Effects of Yoga on Attention, Impulsivity and Hyperactivity in Pre-school Age Children

NCT02642666 | Completed

• 1 other identifier: 801230
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

Attention; Hyperactivity; Impulsivity; Yoga; Preschool

Outcome Measures

Primary Outcomes (4)

• Change in ADHD Rating Scale-IV Preschool Version Scores

  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.

  Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up

• Change in Strengths and Difficulties Questionnaire Scores

  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.

  Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up

• Change in KiTAP Test of Attentional Performance for Children Scores

  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.

  Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up

• Change in Heart rate variability (HRV)

  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.

  Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up

Secondary Outcomes (8)

• Change in Likert scale of "Time on Task" during group yoga classes

  During the six week intervention, after the school based yoga classes

• Change in Strategies Used to Address Challenging Behaviors

  Baseline, after the first six week yoga intervention, after the second six week yoga intervention, 3 month follow up

• Parent and Teacher Satisfaction Questionnaire

  After 6 to 12 weeks

• Parent and Teacher Perception Questionnaire

  After 6 to 12 weeks

• Feasibility

  Through study completion, an average of 18 weeks

Study Arms (2)

Yoga intervention

EXPERIMENTAL

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

Normal school and home activities

NO INTERVENTION

While in the wait-list group the children will continue with their regular activities both at home and at school.

Interventions

Children's Yoga BEHAVIORAL

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.

Yoga intervention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Triumph Center for Early Childhood Education

Sacramento, California, 95820, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm; Impulsive Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Samantha C Cohen, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)