TerminatedNot Applicable

Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for ADHD

Stopped: Study closed by the IRB when PI did not submit for annual review.

United States12 participantsStarted 2022-03-09

Plain-language 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.

Who can participate

Age range

36 Months – 71 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Age 3-years, to 5-years, 11-months * Diagnosis or provisional diagnosis of ADHD or overactivity by the primary care physician, psychologist or neurologist * No diagnosis of neurological disorders other than ADHD * Normal or corrected vision * Cognitive skills to follow verbal instruction * Gross and fine motor skills to engage in sensorimotor activities and school readiness tasks Exclusion Criteria: * Participants will be excluded if they currently take medication for ADHD or exhibit severe physical impairments that result in inability to engage in the SenPlay intervention, fine motor and visual motor activities.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in focused attention as measured by Momentary Time Sampling from intervention one to intervention three.

Timeframe: Intervention session one (week one) to intervention session three (week three).

Trial details

NCT IDNCT05222321

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-19

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials

Who can participate

Age range

36 Months – 71 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.