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Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for ADHD
N/A
Waitlist Available
Led By Thubi Kolobe, PT, Ph.D.
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three time points, once weekly for three weeks.
Summary
This trial tests a sensory-play based intervention to help young children with or at risk for ADHD improve their focus. The intervention uses sensory activities to engage the brain and reduce off-task behaviors. The study aims to see if this method can help children concentrate better on developmentally appropriate tasks.
Eligible Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intervention session one (week one) to intervention session three (week three).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intervention session one (week one) to intervention session three (week three).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in focused attention as measured by Momentary Time Sampling from intervention one to intervention three.
Secondary study objectives
Intensity of physical activity measured at all intervention sessions
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SenPlay Intervention GroupExperimental Treatment1 Intervention
SenPlay is a sensory-play based intervention that includes deep tactile pressure, vestibular and proprioceptive input as a therapeutic medium to facilitate optimal arousal through activities such as pushing, pulling, climbing, jumping, and crashing. These activities are designed to facilitate changes in the child's arousal by providing sensory input and are used at random during the 15 minute window and are facilitated and monitored to ensure the child is reaching a threshold of moderate to vigorous physical activity. All participants will wear the ActiGraph accelerometer to measure the intensity of physical activity during the SenPlay intervention. Intervention sessions will occur at three time points, one per week for three weeks. Following the SenPlay intervention, participants will engage in 10 minutes of developmentally appropriate tasks (DAT) lead by the same investigator. DAT will be videotaped and coded for off task behaviors using Momentary Time Sampling (MTS).
Group II: Free play Control GroupPlacebo Group1 Intervention
The control group will engage in spontaneous, free play with the investigator supervising only for safety within the sensorimotor gym for 15 minutes, prior to the assessment of off-task behaviors during 10 minutes of developmentally appropriate tasks (DAT). All participants will wear the ActiGraph accelerometer to measure the intensity of physical activity reached during spontaneous, free play. Participants in the control group will participate in three sessions, one per week for three weeks. Intervention sessions will occur at three time points, one per week for three weeks. Following the spontaneous play, participants will engage in 10 minutes of developmentally appropriate tasks (DAT) lead by the same investigator. DAT will be videotaped and coded for off task behaviors using Momentary Time Sampling (MTS).
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Who is running the clinical trial?
University of OklahomaLead Sponsor
474 Previous Clinical Trials
93,682 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
81 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Thubi Kolobe, PT, Ph.D.Principal InvestigatorUniversity of Oklahoma