Fidget Ball for ADHD

Overseen By Jared Borden

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must be taking: Stimulants

Must not be taking: Psychoactive medications

Disqualifiers: Depression, Psychotic disorders, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

109 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a fidget ball (a type of sensory toy) can help adults with ADHD improve focus and manage emotions better. Participants will either use a fidget ball or not, and researchers will study the effects on thinking and feelings. The data collected may aid in developing future tools and tips for managing ADHD in everyday settings. The trial seeks adults with ADHD who often fidget and are not using certain medications or have other specific conditions. As an unphased trial, this study offers a unique opportunity to contribute to innovative ADHD management strategies.

Will I have to stop taking my current medications?

The trial requires that you stop taking any psychoactive medications, except for stimulant medications for ADHD or medications that can affect heart rate.

What prior data suggests that this fidget device is safe for adults with ADHD?

Research has shown that fidget toys, such as the fidget ball, are generally safe. Although specific studies on fidget balls for ADHD are lacking, these sensory toys are popular for helping individuals with ADHD improve focus. While detailed safety data for adults is not available, caution is advised with fidget toys around children due to potential choking hazards. Since this trial targets adults, those risks are reduced. Overall, fidget toys are widely used with few reported issues in adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the fidget ball for ADHD because it offers a non-pharmacological approach to managing symptoms. Unlike traditional treatments like stimulant medications (e.g., Ritalin or Adderall) that alter brain chemistry, the fidget ball provides a simple, hands-on tool to help improve focus and reduce restlessness. This treatment is unique as it engages the motor system, potentially allowing kids to channel their excess energy in a productive way without the side effects associated with medication.

What evidence suggests that using a fidget ball is effective for ADHD?

Research has shown that fidgeting can help people with ADHD pay better attention. One study found that fidget spinners helped students with ADHD stay focused on their tasks. Another study suggested that fidgeting might help adults with ADHD maintain attention during challenging mental tasks. Research is also exploring whether high-tech fidget devices can improve focus and reduce anxiety in adults with ADHD. While not all results agree, fidget tools have shown promise as useful aids in managing ADHD symptoms. In this trial, participants will either use a specially designed fidget ball or refrain from using any fidget device to evaluate its effectiveness in managing ADHD symptoms. ^{3 6 7 8 9}

Who Is on the Research Team?

Julie B Schweitzer, PhD

Principal Investigator

UC Davis MIND Institute

Are You a Good Fit for This Trial?

This trial is for adults with ADHD who often fidget. Participants should not have severe depression, psychotic disorders, autism, significant visual or hearing impairments, an IQ below 85, or be on psychoactive meds (except for ADHD stimulants).

Inclusion Criteria

You have been diagnosed with ADHD (Attention-Deficit/Hyperactivity Disorder).

You have a history of being unable to sit still or constantly moving around.

Exclusion Criteria

I am on medication for mental health, but not for ADHD or anything that affects heart rate.

I do not have any mental health issues or sensory impairments that would affect my participation.

Your IQ (intelligence quotient) score is lower than 85.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are assessed for cognitive and emotional regulation with and without a fidget device in a laboratory setting

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any changes in cognitive and emotional regulation post-assessment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fidget ball

Trial Overview The study examines if a 'fidget ball' can help adults with ADHD better manage their attention and emotions. It will collect data in a lab setting to see if this device improves cognitive and emotional control.

How Is the Trial Designed?

Group I: With fidget Experimental Treatment 1 Intervention

The participant is given a specially designed fidget ball

Group II: No fidget Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Published Research Related to This Trial

Fidget spinners, while popular among children and marketed for benefits like improved concentration and reduced stress, lack scientific evidence to support these claims, similar to other sensory toys used in therapy.

Parents should be cautious of potential choking hazards associated with fidget spinners and consult pediatricians, as there are no peer-reviewed studies validating their effectiveness for children with attention or sensory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fidget spinners: Purported benefits, adverse effects and accepted alternatives. Schecter, RA., Shah, J., Fruitman, K., et al.[2018]

Using therapy balls as seating for students with ADHD led to improved in-seat behavior and increased legible word productivity, based on a study involving 3 students in a 4th grade classroom.

Both teachers and students expressed a preference for therapy balls over traditional chairs, indicating positive social validity for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classroom seating for children with attention deficit hyperactivity disorder: therapy balls versus chairs. Schilling, DL., Washington, K., Billingsley, FF., et al.[2019]

In a study of 1,095 pediatric accidental foreign body ingestions, 10 involved fidget spinner components, which were more likely to require endoscopic intervention compared to other ingested items (50% vs. 14%).

Children who ingested fidget spinner parts were generally older (average age 7.1 years) and more likely to be on ADHD medication, highlighting a potential link between fidget spinner use and this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic appearance and clinical significance of fidget spinner ingestions. Sammer, MBK., Kan, JH., Sammer, MD., et al.[2019]

Children with ADHD and typically developing children showed no significant differences in their choice of play partners, with classmates being the most common choice for both groups.

However, children with ADHD preferred to play in school settings and favored educational toys, while typically developing children preferred playing on the street and engaging with electronic games.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Play preference of children with ADHD and typically developing children in Brazil: a pilot study. Pfeifer, LI., Terra, LN., dos Santos, JL., et al.[2015]

The study found that using fidget spinners significantly increased on-task behavior in three second-grade students with ADHD during language arts class, indicating a positive effect on their ability to focus.

The research utilized a multiple-baseline design and momentary time sampling to effectively measure and analyze the improvements in attention, suggesting that fidget spinners can be a useful tool in classroom settings for students with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Fidget Spinners to Improve On-Task Classroom Behavior for Students With ADHD. Aspiranti, KB., Hulac, DM.[2022]

Fidget spinners activate several brain regions, including the supplementary motor area (SMA) and striatum, which are involved in motor control and planning, indicating a potential neurobiological basis for their use in improving attention and motor skills.

Easier-to-rotate fidget spinners lead to greater activation in the SMA and increased connectivity with the caudate, suggesting that the ease of rotation may enhance the motor control benefits associated with using fidget spinners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortico-striatal activity associated with fidget spinner use: an fMRI study. Narukawa, S., Nishimura, M., Kuze, I., et al.[2023]

In a study involving 60 children with ADHD, the use of fidget spinners was linked to decreased gross motor activity during the initial phase of an intensive behavioral treatment, but this effect was not observed in the final phase.

Fidget spinners were associated with poorer attentional functioning in children with ADHD throughout both phases of treatment, suggesting they may not be beneficial in improving focus in classroom settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To Fidget or Not to Fidget, That Is the Question: A Systematic Classroom Evaluation of Fidget Spinners Among Young Children With ADHD. Graziano, PA., Garcia, AM., Landis, TD.[2022]

A review of 43 studies involving around 7000 children found that common adverse drug reactions (ADRs) from ADHD medications included decreased appetite, gastrointestinal pain, and headaches, primarily reported by children or their parents.

Most studies reported low rates of serious ADRs, but many children dropped out due to serious reactions, suggesting that the actual incidence of serious ADRs may be higher, highlighting the need for long-term safety studies on ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Aagaard, L., Hansen, EH.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11246969/

A quantitative analysis of fidgeting in ADHD and its relation to ... Our study suggests that fidgeting may aid in sustained attention during the attention-demanding, cognitive control processes for adults with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9120292/

Using Fidget Spinners to Improve On-Task Classroom ... Conclusion. The present study provides the first known use of fidget spinners as an intervention device to increase on-task behavior for students with ADHD. ...

3. health.ucdavis.edu health.ucdavis.edu/news/headlines/toy-or-therapy-device-uc-davis-health-researchers-study-effectiveness-of-fidget-tools/2020/07

Toy or therapy device? UC Davis Health researchers study ... The study will assess whether a high-tech fidget device increases focus and relieves anxiety in adults with ADHD, which is particularly relevant ...

4. withpower.com withpower.com/trial/fidget-ball-for-adhd-beaac

Fidget Ball for ADHD One study found that fidget spinners helped some students with ADHD stay on task in class, while another study found they could actually worsen attention in ...

5. files.eric.ed.gov files.eric.ed.gov/fulltext/EJ1272882.pdf

Examining the Effectiveness of Fidgets on Attention of ... This study examined the effectiveness of using hand and foot fidgets to increase the focused instructional attention of four elementary students ...

6. galfandberger.com galfandberger.com/2017/08/31/child-safety-alert-fidget-spinners-can-puncture-skin-eyes/

Philadelphia Product Liability Lawyers | Fidget Spinner ... Child Safety Alert: Fidget Spinners Can Puncture Skin and Eyes · Never allow children under 3 to use or be near fidget spinners; · Warn every ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28692449/

Fidget spinners: Purported benefits, adverse effects and ... Thus, their alleged benefits remain scientifically unfounded. Paediatricians should be aware of potential choking hazards with this new fad, and inform parents ...

8. autismparentingmagazine.com autismparentingmagazine.com/fidget-spinners-not-adhd-treatment/?srsltid=AfmBOoqy6Yospy8Yt_kcnp20So8Si4OUoztGAEKUw90slVEaau4bjuro

Experts' Advice: Fidget Spinners Are Not for ADHD ... Fidget spinners have been marketed as easy to carry anxiety-busting gadgets that can aid children and adults with attention deficit hyperactive disorder (ADHD)

9. focusbear.io focusbear.io/blog-post/adhd-sensory-toys-benefits-and-top-choices-for-adults

ADHD Sensory Toys: Benefits and Top Choices for Adults. Sensory toys, also known as fidget or ADHD toys, are designed with the purpose of aiding individuals with ADHD in improving their focus and concentration.