Attention Deficit Hyperactivity DisorderNCT05222321
Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for ADHD
A study testing Sensory-Play Based (SenPlay) Intervention and Spontaneous, Free Play in people with Attention Deficit Hyperactivity Disorder, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Sensory-Play Based (SenPlay) Intervention and Spontaneous, Free Play
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 19 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for Attention Deficit Hyper Activity Disorder (ADHD)
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.
Read the 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
- Attention Deficit Hyperactivity Disorder
- Being tested
- Sensory-Play Based (SenPlay) Intervention, Spontaneous, Free Play
- Keywords
- Attention, Focused attention, Sensory, Play-based intervention, Occupational therapy, Pediatrics
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory-Play Based (SenPlay) InterventionOther
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.
Spontaneous, Free PlayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Spontaneous, Free Play |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intervention session one (week one) to intervention session three (week three).
Secondary outcomes (1)
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.
Measured: Three time points, once weekly for three weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start9 Mar 2022
- Primary completion19 May 2022
- Study completion19 May 2022
Why it stopped: Study closed by the IRB when PI did not submit for annual review.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thubi Kolobe, PT, Ph.D., Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222321
- Sponsor's protocol ID
- 14128
- Status last verified
- Jul 2024
- First submitted
- 18 Jan 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 30853857Barton 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.
PubMed 25460221Gaertner 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.
PubMed 19112517Lin 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.
PubMed 23118541Mangeot 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.
PubMed 11409829Miller 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.
PubMed 17436845Miller 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.
PubMed 22236629NICHD 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.
PubMed 15656741Wan 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.
PubMed 26092640Zentall 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.
PubMed 6657825Fedewa 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.
PubMed 21834454Mah, 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.
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
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.
PubMed 15257968Pollock, N. Sensory integration: A review of the current state of the evidence, Occupational Therapy Now. 2009; 11
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory-Play Based (SenPlay) Intervention for Young Children With or At Risk for Attention Deficit Hyper Activity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT05222321
- Acronym / sponsor ID
- 14128
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention, Focused attention, Sensory, Play-based intervention, Occupational therapy, Pediatrics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed by the IRB when PI did not submit for annual review.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SenPlay Intervention Group | Experimental | Other: Sensory-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 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 | Other: Spontaneous, Free PlayThe 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). |
Who may qualify
- Ages
- 36 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory-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. | Other | SenPlay Intervention Group |
| Spontaneous, 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. | Other | Free play Control Group |
Primary outcome
Change in focused attention as measured by Momentary Time Sampling from intervention one to intervention three.
Time frame: 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.
1 secondary outcome
Intensity of physical activity measured at all intervention sessions
Time frame: Three time points, once weekly for three weeks.
Results and safety
The study was stopped early (reason given: Study closed by the IRB when PI did not submit for annual review.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Results publication: PubMed 30853857Acar 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 publication: PubMed 25460221Barton 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 publication: PubMed 19112517Gaertner 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 publication: PubMed 23118541Lin 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 publication: PubMed 11409829Mangeot 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 publication: PubMed 17436845Miller 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 publication: PubMed 22236629Miller 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 publication: PubMed 15656741NICHD 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 publication: PubMed 26092640Wan 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 publication: PubMed 6657825Zentall 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 publication: PubMed 21834454Fedewa 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 publicationMah, 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thubi Kolobe, PT, Ph.D. principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory-Play Based (SenPlay) Intervention and Spontaneous, Free Play in people with Attention Deficit Hyperactivity Disorder, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed by the IRB when PI did not submit for annual review.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in focused attention as measured by Momentary Time Sampling from intervention one to intervention three. (time frame: Intervention session one (week one) to intervention session three (week three).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05222321, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.