The Effects of Yoga on Attention, Impulsivity and Hyperactivity in Pre-school Age Children With ADHD Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in Strengths and Difficulties Questionnaire Scores
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Strengths and Difficulties Questionnaire Scores
时间窗: 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 ADHD Rating Scale-IV Preschool Version Scores
时间窗: 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 Heart rate variability (HRV)
时间窗: 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 KiTAP Test of Attentional Performance for Children Scores
时间窗: 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.
次要结局
- Feasibility(Through study completion, an average of 18 weeks)
- Measure of Adherence with School Yoga Practice(Through study completion, an average of 18 weeks)
- Change in Likert scale of "Time on Task" during group yoga classes(During the six week intervention, after the school based yoga classes)
- Parent and Teacher Perception Questionnaire(After 6 to 12 weeks)
- Qualitative Data About the Feasibility of the Yoga Intervention Using Focus Group Discussions with Parents and Teachers(After 6 to 12 weeks)
- Measure of Adherence with Home Yoga Practice(Through study completion, an average of 18 weeks)
- 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)