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

NCT05222321 | Terminated

• 1 other identifier: 14128
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention; Focused attention; Sensory; Play-based intervention; Occupational therapy; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (1)

• Intensity of physical activity measured at all intervention sessions

  Three time points, once weekly for three weeks.

Study Arms (2)

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).

Other: Sensory-Play Based (SenPlay) Intervention

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).

Other: Spontaneous, Free Play

Interventions

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.

SenPlay Intervention Group

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.

Free play Control Group

Eligibility Criteria

• Age: 36 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Sensational Kids, Inc

Yukon, Oklahoma, 73099, United States

Location

Related Publications (21)

• 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.

  PMID: 30853857 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.

  PMID: 25460221 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.

  PMID: 19112517 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.

  PMID: 23118541 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.

  PMID: 11409829 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.

  PMID: 17436845 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.

  PMID: 22236629 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.

  PMID: 15656741 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.

  PMID: 26092640 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.

  PMID: 6657825 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.

  PMID: 21834454 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

  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.

  PMID: 15257968 RESULT

• Pollock, N. Sensory integration: A review of the current state of the evidence, Occupational Therapy Now. 2009; 11

  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.

  PMID: 17029565 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.

  PMID: 14527115 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

  RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methods

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Thubi Kolobe, PT, Ph.D.

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 3, 2022
• Study Start: March 9, 2022
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)