NCT05384717

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2022

Completed
Last Updated

November 3, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

May 17, 2022

Last Update Submit

November 2, 2022

Conditions

Keywords

Fidget technologyADHDChildrenDevelopmental Psychology

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

EXPERIMENTAL

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

Other: Fidget Device

Control group

PLACEBO COMPARATOR

No fidget choice provided

Other: Control group

Interventions

Fidget spinner, stress ball, pop-it, or fidget cube

Fidget group

No intervention

Control group

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Study Sites (1)

3-C Family Services

Cary, North Carolina, 27513, United States

Location

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

Attention Deficit Disorder with Hyperactivity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Jennifer R Persia

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR
  • Steven G Buzinski

    University of North Carolina, Chapel Hill

    STUDY CHAIR
  • Lori A Schweickert

    3-C Family Services

    STUDY DIRECTOR

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

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.

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.

Locations