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

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Recruiting
CT.gov ID
NCT05384717
Collaborator
3-C Family Services (Other)
24
1
2
5.4
4.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fidget Device
  • Other: Control group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Do Fidget Instruments Enhance Attentional Control and Comprehension in 6-13 Year-olds With Attention Deficit Hyperactivity Disorder (ADHD)?
Actual Study Start Date :
Apr 18, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fidget group

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

Other: Fidget Device
Fidget spinner, stress ball, pop-it, or fidget cube

Placebo Comparator: Control group

No fidget choice provided

Other: Control group
No intervention

Outcome Measures

Primary Outcome Measures

  1. N-back Visual correct ratio [Day 1 (Up to 30 minutes)]

    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

  2. N-back visual response time [Day 1 (Up to 30 minutes)]

    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.

  3. Number of correct multiple choice responses out of 10 [Day 1 (Up to 30 minutes)]

    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

  1. ADHD-RS Home Version Score [Day 1 (Up to 30 minutes)]

    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.

  2. Parent-reported type of ADHD [Day 1 (Up to 30 minutes)]

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

  3. Type of fidget selected [Day 1 (Up to 30 minutes)]

    4 choices of fidget are available to each participant in the experimental group. Categorical variable- fidget spinner, stress ball, pop-it, or fidget cube

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Diagnosis of ADHD
Exclusion Criteria:
  • Psychosis

  • IQ under 70

Contacts and Locations

Locations

Site City State Country Postal Code
1 3-C Family Services Cary North Carolina United States 27513

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • 3-C Family Services

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT05384717
Other Study ID Numbers:
  • 22-0531
First Posted:
May 20, 2022
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of North Carolina, Chapel Hill

Study Results

No Results Posted as of May 20, 2022