Examining the Impacts of Fidget Technology on Attention in Children With ADHD

Study Overview
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Brief Summary
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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.

Official Title
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Do Fidget Instruments Enhance Attentional Control and Comprehension in 6-13 Year-olds With Attention Deficit Hyperactivity Disorder (ADHD)?

Conditions
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ADHD

Intervention / Treatment
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* Other: Fidget Device
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of ADHD Exclusion Criteria: Psychosis IQ under 70

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fidget group<br>Participants in the experimental fidget group select a fidget from 4 options: fidget spinner, stress ball, pop-it, or fidget cube | Other: Fidget Device<br>* Fidget spinner, stress ball, pop-it, or fidget cube<br>|
| Placebo Comparator: Control group<br>No fidget choice provided | Other: Control group<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | Day 1 (Up to 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | Day 1 (Up to 30 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fidget technology, ADHD, Children, Developmental Psychology