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SenPlay Intervention Group for Attention Deficit Hyperactivity Disorder (ADHD)

N/A
Recruiting
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
Diagnosis or provisional diagnosis of ADHD or overactivity by the primary care physician, psychologist or neurologist
No diagnosis of neurological disorders other than ADHD
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthree time points, once weekly for three weeks.
Awards & highlights

Study Summary

The purpose of this pilot study is to determine the effects of 15 minutes of sensory-play based (SenPlay) intervention on improving focused attention in developmentally appropriate tasks in young children with or at risk for ADHD.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have a tumor that is at least 3-years, to 5-years, 11-months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intervention session one (week one) to intervention session three (week three).
This trial's timeline: 3 weeks for screening, Varies for treatment, and intervention session one (week one) to intervention session three (week three). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in focused attention as measured by Momentary Time Sampling from intervention one to intervention three.
Secondary outcome measures
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).

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
449 Previous Clinical Trials
98,399 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
West Virginia
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for ADHD
2022. "Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05222321.
All > Adhd
~7 spots leftby Dec 2024
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