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

Sponsor

University of Oklahoma (Other)

Overall Status

Recruiting

CT.gov ID

NCT05222321

Collaborator

(none)

Enrollment

Location

Arms

2.2

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Other: Sensory-Play Based (SenPlay) Intervention Other: Spontaneous, Free Play	N/A

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

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 9, 2022

Anticipated Primary Completion Date :

May 15, 2022

Anticipated Study Completion Date :

May 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SenPlay Intervention Group 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).	Other: Sensory-Play Based (SenPlay) 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 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.
Placebo Comparator: Free play Control Group 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).	Other: Spontaneous, Free Play Participant 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.

Arm

Intervention/Treatment

Experimental: SenPlay Intervention Group

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).

Other: Sensory-Play Based (SenPlay) Intervention

Placebo Comparator: Free play Control Group

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).

Other: Spontaneous, Free Play

Participant 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.

Outcome Measures

Primary Outcome Measures

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

Intensity of physical activity measured at all intervention sessions [Three time points, once weekly for three weeks.]
The ActiGraph (GTX3) accelerometer will be used to measure the intensity of physical activity (PA) for each child while engaged in the SenPlay intervention and spontaneous, free play.

Eligibility Criteria

Criteria

Ages Eligible for Study:

36 Months to 71 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.