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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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 measu
Sponsor: University of California, Davis

Current Primary Outcome:

  • 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 perce

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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.


    Original Secondary Outcome: Same as current

    Information By: University of California, Davis

    Dates:
    Date Received: December 23, 2015
    Date Started: December 2015
    Date Completion:
    Last Updated: October 24, 2016
    Last Verified: October 2016