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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensory-Play Based (SenPlay) Intervention
Spontaneous, Free Play
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention, Focused attention, Sensory, Play-based intervention, Occupational therapy, Pediatrics

Eligibility Criteria

36 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sensational Kids, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SenPlay Intervention Group

Free play Control Group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 18, 2022
Last Updated
April 11, 2022
Sponsor
University of Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT05222321
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
May 15, 2022 (Anticipated)
Study Completion Date
May 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention, Focused attention, Sensory, Play-based intervention, Occupational therapy, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SenPlay Intervention Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Free play Control Group
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Sensory-Play Based (SenPlay) Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Spontaneous, Free Play
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in focused attention as measured by Momentary Time Sampling from intervention one to intervention three.
Description
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.
Time Frame
Intervention session one (week one) to intervention session three (week three).
Secondary Outcome Measure Information:
Title
Intensity of physical activity measured at all intervention sessions
Description
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.
Time Frame
Three time points, once weekly for three weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kari A Casarez, MOT
Phone
4059909835
Email
kari-casarez@ouhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Thubi Kolobe, PT, Ph.D.
Phone
4052712131
Email
hkolobe@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thubi Kolobe, PT, Ph.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sensational Kids, Inc
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kari A Casarez, MOT
Phone
405-578-9770
Email
kari@sensationalkidsokc.com
First Name & Middle Initial & Last Name & Degree
Kari A Casarez, MOT

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No identifiable study data will be shared with any outside entities. The subject's information will not be used or distributed for future research studies even if identifiers are removed.
Citations:
PubMed Identifier
30853857
Citation
Acar IH, Frohn S, Prokasky A, Molfese VJ, Bates JE. Examining the Associations Between Performance Based and Ratings of Focused Attention in Toddlers: Are We Measuring the Same Constructs? Infant Child Dev. 2019 Jan-Feb;28(1):e2116. doi: 10.1002/icd.2116. Epub 2018 Oct 22.
Results Reference
result
PubMed Identifier
25460221
Citation
Barton EE, Reichow B, Schnitz A, Smith IC, Sherlock D. A systematic review of sensory-based treatments for children with disabilities. Res Dev Disabil. 2015 Feb;37:64-80. doi: 10.1016/j.ridd.2014.11.006. Epub 2014 Nov 25.
Results Reference
result
PubMed Identifier
19112517
Citation
Gaertner BM, Spinrad TL, Eisenberg N. Focused Attention in Toddlers: Measurement, Stability, and Relations to Negative Emotion and Parenting. Infant Child Dev. 2008 Aug;17(4):339-363. doi: 10.1002/ICD.580.
Results Reference
result
PubMed Identifier
23118541
Citation
Lin CL, Min YF, Chou LW, Lin CK. Effectiveness of sensory processing strategies on activity level in inclusive preschool classrooms. Neuropsychiatr Dis Treat. 2012;8:475-81. doi: 10.2147/NDT.S37146. Epub 2012 Oct 23.
Results Reference
result
PubMed Identifier
11409829
Citation
Mangeot SD, Miller LJ, McIntosh DN, McGrath-Clarke J, Simon J, Hagerman RJ, Goldson E. Sensory modulation dysfunction in children with attention-deficit-hyperactivity disorder. Dev Med Child Neurol. 2001 Jun;43(6):399-406. doi: 10.1017/s0012162201000743.
Results Reference
result
PubMed Identifier
17436845
Citation
Miller LJ, Coll JR, Schoen SA. A randomized controlled pilot study of the effectiveness of occupational therapy for children with sensory modulation disorder. Am J Occup Ther. 2007 Mar-Apr;61(2):228-38. doi: 10.5014/ajot.61.2.228.
Results Reference
result
PubMed Identifier
22236629
Citation
Miller LJ, Nielsen DM, Schoen SA. Attention deficit hyperactivity disorder and sensory modulation disorder: a comparison of behavior and physiology. Res Dev Disabil. 2012 May-Jun;33(3):804-18. doi: 10.1016/j.ridd.2011.12.005. Epub 2012 Jan 11.
Results Reference
result
PubMed Identifier
15656741
Citation
NICHD Early Child Care Research Network. Predicting individual differences in attention, memory, and planning in first graders from experiences at home, child care, and school. Dev Psychol. 2005 Jan;41(1):99-114. doi: 10.1037/0012-1649.41.1.99.
Results Reference
result
PubMed Identifier
26092640
Citation
Wan Yunus F, Liu KP, Bissett M, Penkala S. Sensory-Based Intervention for Children with Behavioral Problems: A Systematic Review. J Autism Dev Disord. 2015 Nov;45(11):3565-79. doi: 10.1007/s10803-015-2503-9.
Results Reference
result
PubMed Identifier
6657825
Citation
Zentall SS, Zentall TR. Optimal stimulation: a model of disordered activity and performance in normal and deviant children. Psychol Bull. 1983 Nov;94(3):446-71. No abstract available.
Results Reference
result
PubMed Identifier
21834454
Citation
Fedewa AL, Erwin HE. Stability balls and students with attention and hyperactivity concerns: implications for on-task and in-seat behavior. Am J Occup Ther. 2011 Jul-Aug;65(4):393-9. doi: 10.5014/ajot.2011.000554.
Results Reference
result
Citation
Mah, J, Doherty, M. Sensorimotor intervention group for children with ADHD and sensory processing difficulties: A feasibility study. Journal of Child and Family Studies. 2021; 30, 447-459.
Results Reference
result
Citation
McGoey, K. Schreiber, J, Venesky, L., Westwood, W., McGuirk, L., Schaffner, K. Factor structure of attention deficit hyperactivity disorder symptoms for children age 3 to 5 years. Journal of Psychoeducational Assessment. 2015; 33(5), 430-438
Results Reference
result
PubMed Identifier
15257968
Citation
Olson LJ, Moulton HJ. Use of weighted vests in pediatric occupational therapy practice. Phys Occup Ther Pediatr. 2004;24(3):45-60. doi: 10.1300/j006v24n03_04.
Results Reference
result
Citation
Pollock, N. Sensory integration: A review of the current state of the evidence, Occupational Therapy Now. 2009; 11
Results Reference
result
PubMed Identifier
17029565
Citation
Posner MI, Rothbart MK. Research on attention networks as a model for the integration of psychological science. Annu Rev Psychol. 2007;58:1-23. doi: 10.1146/annurev.psych.58.110405.085516.
Results Reference
result
PubMed Identifier
14527115
Citation
Schilling DL, Washington K, Billingsley FF, Deitz J. Classroom seating for children with attention deficit hyperactivity disorder: therapy balls versus chairs. Am J Occup Ther. 2003 Sep-Oct;57(5):534-41. doi: 10.5014/ajot.57.5.534.
Results Reference
result
Citation
Seifert, AM. Metz, AE. The effects of inflated seating cushions on engagement in preschool circle time. Early Childhood Education Journal. 2016; 45(3), 411-418
Results Reference
result
Citation
Sirard, J., Trost, S., Pfeiffer, K., Dowda, M., Pate, R. Calibration and evaluation of an objective measure of physical activity in preschool children. Journal of Physical Activity and Health. 2005; 3, 345-357
Results Reference
result
Citation
Wood, BK., Hojnoski, RL., Laracy, SD., Olson, CL. Comparison of observational methods and their relation to ratings of engagement in young children. Topics in Early Childhood Special Education. 2016; 35, 211-222
Results Reference
result
Citation
Zakszeski, BN., Hojnoski, RL., Wood, BK. Considerations for Time Sampling Interval Durations in the Measurement of Young Children's Classroom Engagement. Topics in Early Childhood Special Education. 2017; 37(1), 42-53
Results Reference
result

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

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