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

Primary Purpose

ADHD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fidget Device
Control group
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ADHD focused on measuring Fidget technology, ADHD, Children, Developmental Psychology

Eligibility Criteria

6 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of ADHD

Exclusion Criteria:

  • Psychosis
  • IQ under 70

Sites / Locations

  • 3-C Family Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fidget group

Control group

Arm Description

Participants in the experimental fidget group select a fidget from 4 options: fidget spinner, stress ball, pop-it, or fidget cube

No fidget choice provided

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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.
Parent-reported type of ADHD
Parents indicate the type of ADHD their child presents with. Categorical variable: Inattentive, Hyperactive, or Combined
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

Full Information

First Posted
May 17, 2022
Last Updated
November 2, 2022
Sponsor
University of North Carolina, Chapel Hill
Collaborators
3-C Family Services
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1. Study Identification

Unique Protocol Identification Number
NCT05384717
Brief Title
Examining the Impacts of Fidget Technology on Attention in Children With ADHD
Official Title
Do Fidget Instruments Enhance Attentional Control and Comprehension in 6-13 Year-olds With Attention Deficit Hyperactivity Disorder (ADHD)?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
September 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
3-C Family Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
Fidget technology, ADHD, Children, Developmental Psychology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fidget group
Arm Type
Experimental
Arm Description
Participants in the experimental fidget group select a fidget from 4 options: fidget spinner, stress ball, pop-it, or fidget cube
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
No fidget choice provided
Intervention Type
Other
Intervention Name(s)
Fidget Device
Intervention Description
Fidget spinner, stress ball, pop-it, or fidget cube
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
No intervention
Primary Outcome Measure Information:
Title
N-back Visual correct ratio
Description
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)
Title
N-back visual response time
Description
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)
Title
Number of correct multiple choice responses out of 10
Description
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)
Secondary Outcome Measure Information:
Title
ADHD-RS Home Version Score
Description
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)
Title
Parent-reported type of ADHD
Description
Parents indicate the type of ADHD their child presents with. Categorical variable: Inattentive, Hyperactive, or Combined
Time Frame
Day 1 (Up to 30 minutes)
Title
Type of fidget selected
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of ADHD Exclusion Criteria: Psychosis IQ under 70
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer R Persia
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven G Buzinski
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lori A Schweickert
Organizational Affiliation
3-C Family Services
Official's Role
Study Director
Facility Information:
Facility Name
3-C Family Services
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
beginning 9 to 36 months following publication
IPD Sharing Access Criteria
Researcher has approved from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Citations:
Citation
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
Results Reference
result

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

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