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



Status:Recruiting
Conditions:Neurology, Psychiatric, ADHD
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:3 - 5
Updated:4/21/2016
Start Date:December 2015
End Date:August 2016
Contact:Samantha C Lewis, MD
Email:sclewis@ucdavis.edu
Phone:626-825-0927

Use our guide to learn which trials are right for you!

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

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.

Background: Symptoms of attention-deficit hyperactivity disorder (ADHD) are often observable
by preschool age and can be associated with similar behavioral, social, and cognitive
impairments as seen in older children with ADHD. Seventy to eighty percent of preschoolers
with symptoms of ADHD continue to display these symptoms in elementary school. Behavioral
therapies are recommended as first line treatments in this age group. There have been some
small but promising studies looking at yoga as an intervention for school age children with
ADHD, but none have looked specifically at yoga as an intervention for preschool age
children with ADHD symptoms (Birdee et al, 2009).

Objective: To determine if yoga improves hyperactive/impulsive symptoms and attention in
preschool age children with or "at risk" for ADHD.

Study design: A randomized wait-list controlled trial exploring whether 6 weeks of
children's yoga improves behavioral symptoms, task-related scores of attention, and
increases heart rate variability in preschool age children "at risk" for or diagnosed with
ADHD. The investigators plan to enroll a total of 30 children ages 3-5 years old. "At risk"
for ADHD will be defined as four or more inattentive or hyperactive/impulsive symptoms rated
by parents and teachers on the ADHD Rating Scale-IV Preschool Version.

Procedures: The investigators will evaluate the efficacy of yoga for improving ADHD and
other behavioral symptoms using parent and teacher rating scales (ADHD Rating Scale-IV
Preschool Version; Strengths and Difficulties Questionnaire), as well as objective measures
including computer based tasks of attention and executive function (KiTAP, Test of
Attentional Performance for Children), and heart rate variability (HRV), a physiologic
measure of self-regulatory capacity. HRV will be assessed during an active, attention
computer task (using the emWave ® desktop device), as well as during a relaxed state, in a
breathing exercise paired with verbal affirmations. The protocol includes baseline,
post-treatment and 3 month follow-up assessments. The intervention consists of school and
home yoga sessions. School sessions will be held twice a week at Triumph Center for Early
Childhood Education, which is a local preschool associated with University of California,
Davis. The school based yoga classes will be lead by trained child yoga instructors using a
manualized yoga protocol that is 30 minute long. Home session will include use of a
children's yoga video featuring the same protocol to practice at home on the days that the
children do not participate at school. The goal is for daily yoga practice during the 6 week
intervention period. Home yoga practice will be documented daily by parents completing a
brief online survey that is emailed to them. Generalization of the skills learned during the
yoga sessions to behaviorally-challenging situations will be specifically developed by
teaching the parents and teachers to "cue" the children to integrate skills learned in the
yoga sessions into their daily routine. The goal is for the children to learn to use
breathing practices and affirmations to help regain calmness and focus when their behaviors
become challenging. A questionnaire will assess parent and teacher perception regarding the
use of yoga in the children's daily life, its effect on challenging behaviors, and their
satisfaction with the intervention. Optional focus groups will also be done with the parents
and teachers of the children who participate in the study in order to gather qualitative
data about the yoga intervention.

Statistical Methods and Power Analysis: Outcome distributions will be visualized and, if
necessary, log-transformed to reduce skewness or stabilize variances. For this wait-list
design, the primary assessment of treatment effects will be estimated by comparing treatment
and control groups on baseline-adjusted mean outcomes at the first follow-up and reported
with 95% Confidence Intervals. Between- and within-group contrasts involving outcomes at the
2nd follow-up time will permit exploration of treatment durability. The primary index of HRV
will be the standard deviation of beat-to-beat intervals, but other time- and
frequency-domain indices will be evaluated in exploratory analyses. Assuming pre/post
correlations of 60%, our target sample size of 30 subjects will permit estimating treatment
effects with margins of error of 0.41 standard deviations and provide 80% power (with
2-sided alpha=5%) to detect between-group effects as small as 0.59 standard deviations.

Gaps in knowledge: The majority of the studies on yoga for children with ADHD have been
conducted in school aged children, and only one was completed in the United States. None
have looked specifically at yoga as an intervention for ADHD symptoms in preschoolers. In
addition, none of these studies included physiologic measures such as vagal tone, which has
been shown to increase in adults who practice yoga. Physiologic measures are valuable
because they are an objective measure of treatment response, may give evidence to support
the role, and perhaps mechanism by which yoga may affect change in ADHD. The investigators
will assess heart rate variability (HRV), a measure of the beat-to-beat changes in heart
rate, which reflects the activity of the vagus nerve, a key component of the parasympathetic
nervous system, which mediates changes in heart rate. Reduced HRV is associated with
increased morbidity and mortality, while increased HRV is associated with physiologic
resiliency, the ability to self-regulate and improved performance on tasks of executive
function. Compared to healthy controls, children with ADHD have higher mean heart rates, and
unmedicated children have significantly decreased HRV. In adults, HRV has been found to
increase in response to both exercise and biofeedback. A study in children with ADHD
evaluated the use of biofeedback using HRV coherence, synchronization of the heart rhythm
pattern, and found that it improved cognitive function and behaviors. HRV has not been
evaluated in relation to yoga training in young children with ADHD symptoms.

Innovation: This project is novel in its subject population, preschoolers, teaching of yoga
at the school, use of manualized treatments, objective measures and wait-list randomized
control methodology. While there are many studies in exercise, yoga and meditation for
children, many lack sophisticated methodology to guide clinical practice. The proposed
methods are not highly innovative, but they are critical to moving the field forward and
providing direction to clinicians, parents and teachers in need of research to guide their
clinical decision-making.

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
We found this trial at
1
site
Sacramento, California 95820
Principal Investigator: Samantha C Lewis, MD
Phone: 626-825-0927
?
mi
from
Sacramento, CA
Click here to add this to my saved trials