Clinical trial NCT05222321: Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for ADHD
Official title: Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for Attention Deficit Hyper Activity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention
Focused attention
Sensory
Play-based intervention
Occupational therapy
Pediatrics
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 12
Sex: ALL
Minimum age (years): 36
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To address the aims of this study, the investigators will recruit 20 participants and utilize a randomized, experimental study with a two-group longitudinal, pre-posttest, linear association study design to measure attention levels and off-task behaviors. This is the first step in determining the effects of the SenPlay intervention on focused attention. The intervention will occur over three time points in a clinic therapy room and occupational therapy gym in an outpatient pediatric clinic.
Primary purpose: TREATMENT

Brief 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.

Detailed description: After being informed about the study and potential risks, written consent will be obtained by the investigators. Twenty participants will be recruited for this randomized, experimental study with a two-group longitudinal, pre-posttest, linear association study design to measure attention levels and off-task behaviors. All participants will attend a total of four sessions. The investigator, a registered, licensed occupational therapist, will lead all intervention sessions utilizing a set protocol. Participants will complete an intake session to determine baseline fine motor skills for developmentally appropriate tasks (DAT) before being randomly assigned to either the control group or the SenPlay intervention group. The control group will engage in spontaneous, free play with the supervising only for safety within the sensorimotor gym (see image 1) for 15 minutes, prior to the assessment of off-task behaviors during 10 minutes of DAT. The intervention group will engage in 15-minutes of SenPlay intervention, followed by assessment of off-task behaviors during 10 minutes of DAT. The 10 minutes of DAT will be coded at the beginning of each 15 second interval (Wood et al., 2016) for a total of 40 observation periods. The percentage of on and off-task behaviors will be calculated. Two coders, blinded to the group assignment will code session. Prior to the study, both coders will achieve a reliability of at least 95% accuracy in training sessions.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
Secondary outcomes:
measure: Intensity of physical activity measured at all intervention sessions
timeFrame: Three time points, once weekly for three weeks.
Other outcomes:
Locations:
city: Yukon
country: United States
facility: Sensational Kids, Inc
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Thubi Kolobe, PT, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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