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Study closed by the IRB when PI did not submit for annual review.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SenPlay Intervention Group | Experimental | 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). |
|
| Free play Control Group | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensory-Play Based (SenPlay) Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intervention session one (week one) to intervention session three (week three). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three time points, once weekly for three weeks. |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thubi Kolobe, PT, Ph.D. | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sensational Kids, Inc | Yukon | Oklahoma | 73099 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30853857 | Result | 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. | |
| 25460221 | Result | 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. |
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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.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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.
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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.
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| Spontaneous, Free Play | Other | 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. |
|
| 19112517 | Result | 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. |
| 23118541 | Result | 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. |
| 11409829 | Result | 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. |
| 17436845 | Result | 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. |
| 22236629 | Result | 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. |
| 15656741 | Result | 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. |
| 26092640 | Result | 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. |
| 6657825 | Result | 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. |
| 21834454 | Result | 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. |
| Result | 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. |
| Result | 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 |
| 15257968 | Result | 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. |
| Result | Pollock, N. Sensory integration: A review of the current state of the evidence, Occupational Therapy Now. 2009; 11 |
| 17029565 | Result | 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. |
| 14527115 | Result | 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. |
| Result | 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 |
| Result | 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 |
| Result | 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 |
| Result | 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 |