An interventional study of Fidget Device and Control group in ADHD, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 6 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Other
Purpose: The purpose of this study is to investigate the usage of fidget technology and its effects on attention, working memory, and comprehension in children ages 6-13 with Attention Deficit Hyperactivity Disorder (ADHD). This study aims to examine the implications of fidget usage 2 different measures of attention; attentional control (working memory domain) and comprehension (recall, encoding, and recognition).
Participants: 6-13 year-old clients at 3-C Family Services, a private mental health clinic in Cary, NC, with a diagnosis of ADHD (Inattentive, Hyperactive, or combined types). Exclusion criteria: participants with an Intelligence Quotient (IQ) below 70 as estimated by referring 3-C clinical staff, or any history of psychosis.
Procedures (methods): This research will use a demographic and background collecting survey to gather relevant data about each participant. Parents will be asked to fill out a baseline ADHD Rating Scale-IV: Home Version (ADHD-RS), to account for their child's symptoms of ADHD over the past 6 months. Participants will be randomly assigned to one of 2 conditions, an experimental group where participants select a fidget, and a control group where participants are not provided a fidget. Fidget options will include a fidget spinner, pop-it, stress ball, and fidget cube as not all children would benefit from the same type of fidget equally. Participants in the experimental group will then be allowed to practice with and familiarize themselves with the fidget for 1 minute to decrease the attentional drain that the fidget may pose in its initial state.
After random assignment to either control or experimental group, participants in each group will then complete the same 2-back version of the N-back Attention Control Task (cognitivefun.net), and a video comprehension multiple choice test. After 3 minutes N-back scores will be recorded including visual correct ratio and visual response time scores. The video comprehension item is adapted from Lee and List, 2019. The video is a Ted Talk titled "The Survival of the Sea Turtle" ( https://www.youtube.com/watch?v=t-KmQ6pGxg4). Items in the multiple choice test will be aggregated to a score of percent correctness for each participant. Participants may request to have questions read to them by the research assistant present.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 21 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
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Exclusion Criteria:
Participants in the experimental fidget group select a fidget from 4 options: fidget spinner, stress ball, pop-it, or fidget cube
Other: Fidget Device
No fidget choice provided
Other: Control group
Fidget spinner, stress ball, pop-it, or fidget cube
No intervention
N-back Visual correct ratio
The N-Back task is a measure of working memory. Participants are presented a sequence of stimuli and must decide if the current stimulus is the same as the one presented two trials ago. Max value= 1, min value =0, higher scores are closer to 1
Time frame: Day 1 (Up to 30 minutes)
N-back visual response time
The N-Back task is a measure of working memory. Participants are presented a sequence of stimuli and must decide if the current stimulus is the same as the one presented two trials ago. The lower the score the better (indicates less time to decide on n-back). For response time measure there is no minimum or maximum.
Time frame: Day 1 (Up to 30 minutes)
Number of correct multiple choice responses out of 10
Participants answer 10 multiple choice questions to assess comprehension of Ted Talk video. Multiple choice questions adapted from Lee \& List, 2019. Max value= 10, min value = 0. Best possible score = 10, higher scores are better.
Time frame: Day 1 (Up to 30 minutes)
ADHD-RS Home Version Score
Parents complete a 18 question assessment of child's ADHD symptoms over the past 6 months. Max score= 54, Min score= 0. Higher score indicates more ADHD symptoms.
Time frame: Day 1 (Up to 30 minutes)
Parent-reported type of ADHD
Parents indicate the type of ADHD their child presents with. Categorical variable: Inattentive, Hyperactive, or Combined
Time frame: Day 1 (Up to 30 minutes)
Type of fidget selected
4 choices of fidget are available to each participant in the experimental group. Categorical variable- fidget spinner, stress ball, pop-it, or fidget cube
Time frame: Day 1 (Up to 30 minutes)
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
University of North Carolina, Chapel Hill