Examining the Impacts of Fidget Technology on Attention in Children With ADHD
Do Fidget Instruments Enhance Attentional Control and Comprehension in 6-13 Year-olds With Attention Deficit Hyperactivity Disorder (ADHD)?
1 other identifier
interventional
21
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 18, 2022
CompletedFirst Submitted
Initial submission to the registry
May 17, 2022
CompletedFirst Posted
Study publicly available on registry
May 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2022
CompletedNovember 3, 2022
May 1, 2022
4 months
May 17, 2022
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
ADHD-RS Home Version Score
Day 1 (Up to 30 minutes)
Parent-reported type of ADHD
Day 1 (Up to 30 minutes)
Type of fidget selected
Day 1 (Up to 30 minutes)
Study Arms (2)
Fidget group
EXPERIMENTALParticipants in the experimental fidget group select a fidget from 4 options: fidget spinner, stress ball, pop-it, or fidget cube
Control group
PLACEBO COMPARATORNo fidget choice provided
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of ADHD
You may not qualify if:
- Psychosis
- IQ under 70
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- 3-C Family Servicescollaborator
Study Sites (1)
3-C Family Services
Cary, North Carolina, 27513, United States
Related Publications (1)
Lee, Hye Yeon & List, Alexandra. (2019). Processing of texts and videos: A strategy-focused analysis. Journal of Computer Assisted Learning. 35. 10.1111/jcal.12328
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer R Persia
University of North Carolina, Chapel Hill
- STUDY CHAIR
Steven G Buzinski
University of North Carolina, Chapel Hill
- STUDY DIRECTOR
Lori A Schweickert
3-C Family Services
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2022
First Posted
May 20, 2022
Study Start
April 18, 2022
Primary Completion
August 24, 2022
Study Completion
September 24, 2022
Last Updated
November 3, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- beginning 9 to 36 months following publication
- Access Criteria
- Researcher has approved from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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.