Clinical Trials Directory

Trials / Terminated

TerminatedNCT05222321

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

Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for Attention Deficit Hyper Activity Disorder (ADHD)

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
University of Oklahoma · Academic / Other
Sex
All
Age
36 Months – 71 Months
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSensory-Play Based (SenPlay) InterventionSenPlay is a sensory-play based intervention that includes deep tactile pressure, vestibular and proprioceptive input as a therapeutic medium to facilitate optimal arousal through sensory-play based activities such as pushing, pulling, climbing, jumping, crashing, and swinging. These activities are designed to facilitate changes in the child's arousal through providing sensory input to ensure the child is reaching a threshold of moderate to vigorous physical activity. Completed at three time points, once weekly for three weeks.
OTHERSpontaneous, Free PlayParticipant engages in spontaneous, free play with the investigator supervising only for safety within the sensorimotor gym for 15 minutes. Completed at three time points, once weekly for three weeks.

Timeline

Start date
2022-03-09
Primary completion
2022-05-19
Completion
2022-05-19
First posted
2022-02-03
Last updated
2024-07-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05222321. Inclusion in this directory is not an endorsement.