Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for Attention Deficit Hyper Activity Disorder (ADHD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Oklahoma
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Change in focused attention as measured by Momentary Time Sampling from intervention one to intervention three.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Participants will not be aware of group assignment, but will be notified of their group assignment at the end of the three intervention sessions upon request. The percentage of on and off-task behaviors will be calculated by 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
- Ages
- 36 Months to 71 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Change in focused attention as measured by Momentary Time Sampling from intervention one to intervention three.
Time Frame: Intervention session one (week one) to intervention session three (week three).
Momentary Time Sampling (MTS) using a MTS observation chart will be used to code on and off task behaviors when engaged in developmentally appropriate task (DAT) for three sessions per participant. Sessions will be recorded using a video camera and coded to ensure completeness of data tracking for on and off-task behaviors. Using MTS, the child's behavior is coded at the beginning of every 15 second time interval using a stopwatch to ensure 15 second intervals. Focused attention will be measured by calculating the percentage of on and off-task behaviors with all data collection and coding methods being the same for all participants in both groups. On-task behaviors are operational defined as behaviors in which both the eyes and hands are focused on the task, appropriately responding to the investigator's verbal instruction, and manipulation of materials as instructed by the investigator while off-task behaviors include any behavior not meeting the criteria of an on-task behavior.
Secondary Outcomes
- Intensity of physical activity measured at all intervention sessions(Three time points, once weekly for three weeks.)