ADHDNCT05384717
Examining the Impacts of Fidget Technology on Attention in Children With ADHD
A study testing Fidget Device in people with ADHD, run by University of North Carolina, Chapel Hill at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Fidget Device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 24 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of ADHD
Who cannot join
- Psychosis
- IQ under 70
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Fidget Instruments Enhance Attentional Control and Comprehension in 6-13 Year-olds With Attention Deficit Hyperactivity Disorder (ADHD)?
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.
Read more
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.
- Conditions
- ADHD
- Being tested
- Fidget Device, Control group
- Keywords
- Fidget technology, ADHD, Children, Developmental Psychology
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fidget DeviceOther
Fidget spinner, stress ball, pop-it, or fidget cube
Control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Fidget group | Experimental | Participants in the experimental fidget group select a fidget from 4 options: fidget spinner, stress ball, pop-it, or fidget cube Receives: Other: Fidget Device |
| Control group | Placebo comparator | No fidget choice provided Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Day 1 (Up to 30 minutes)
Secondary outcomes (3)
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.
Measured: Day 1 (Up to 30 minutes)
Parent-reported type of ADHD
Parents indicate the type of ADHD their child presents with. Categorical variable: Inattentive, Hyperactive, or Combined
Measured: Day 1 (Up to 30 minutes)
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
Measured: Day 1 (Up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start18 Apr 2022
- Primary completion24 Aug 2022
- Study completion24 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- 3-C Family Services
- Responsible party
- Sponsor
- Investigators
- Jennifer R Persia, Principal investigator, University of North Carolina, Chapel HillSteven G Buzinski, Study chair, University of North Carolina, Chapel HillLori A Schweickert, Study director, 3-C Family Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384717
- Sponsor's protocol ID
- 22-0531
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Fidget Instruments Enhance Attentional Control and Comprehension in 6-13 Year-olds With Attention Deficit Hyperactivity Disorder (ADHD)?
- ClinicalTrials.gov ID
- NCT05384717
- Acronym / sponsor ID
- 22-0531
- Conditions
- ADHD
- Keywords
- Fidget technology, ADHD, Children, Developmental Psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- 3-C Family Services
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 24 Sep 2022 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fidget group | Experimental | Other: Fidget DeviceParticipants in the experimental fidget group select a fidget from 4 options: fidget spinner, stress ball, pop-it, or fidget cube |
| Control group | Placebo comparator | Other: Control groupNo fidget choice provided |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of ADHD
Key exclusion criteria (2 listed)
- Psychosis
- IQ under 70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fidget DeviceFidget spinner, stress ball, pop-it, or fidget cube | Other | Fidget group |
| Control groupNo intervention | Other | Control group |
Primary outcome
N-back Visual correct ratio
Time frame: 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
N-back visual response time
Time frame: 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.
Number of correct multiple choice responses out of 10
Time frame: 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.
3 secondary outcomes
ADHD-RS Home Version Score
Time frame: Day 1 (Up to 30 minutes)
Parent-reported type of ADHD
Time frame: Day 1 (Up to 30 minutes)
Type of fidget selected
Time frame: Day 1 (Up to 30 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Results publicationLee, Hye Yeon & List, Alexandra. (2019). Processing of texts and videos: A strategy-focused analysis. Journal of Computer Assisted Learning. 35. 10.1111/jcal.12328
- Individual participant dataSharing planned: Yes. 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.
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer R Persia principal investigator
University of North Carolina, Chapel Hill
Steven G Buzinski study chair
University of North Carolina, Chapel Hill
Lori A Schweickert study director
3-C Family Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fidget Device in people with ADHD, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-back Visual correct ratio (time frame: Day 1 (Up to 30 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05384717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.