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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05384717
Other study ID # 22-0531
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2022
Est. completion date September 24, 2022

Study information

Verified date May 2022
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date September 24, 2022
Est. primary completion date August 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 13 Years
Eligibility Inclusion Criteria: - Diagnosis of ADHD Exclusion Criteria: - Psychosis - IQ under 70

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Fidget Device
Fidget spinner, stress ball, pop-it, or fidget cube
Control group
No intervention

Locations

Country Name City State
United States 3-C Family Services Cary North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill 3-C Family Services

Country where clinical trial is conducted

United States, 

References & 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

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
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