Clinical trial NCT05384717: 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
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: Fidget technology
ADHD
Children
Developmental Psychology
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: 3-C Family Services
First posted: 2022-05-20
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ADHD

Exclusion Criteria:

* Psychosis
* IQ under 70

Primary outcomes:
measure: N-back Visual correct ratio
timeFrame: Day 1 (Up to 30 minutes)
measure: N-back visual response time
timeFrame: Day 1 (Up to 30 minutes)
measure: Number of correct multiple choice responses out of 10
timeFrame: Day 1 (Up to 30 minutes)
Secondary outcomes:
measure: ADHD-RS Home Version Score
timeFrame: Day 1 (Up to 30 minutes)
measure: Parent-reported type of ADHD
timeFrame: Day 1 (Up to 30 minutes)
measure: Type of fidget selected
timeFrame: Day 1 (Up to 30 minutes)
Other outcomes:
Locations:
city: Cary
country: United States
facility: 3-C Family Services
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer R Persia
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Steven G Buzinski
role: STUDY_CHAIR
affiliation: 3-C Family Services
name: Lori A Schweickert
role: STUDY_DIRECTOR
References:
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