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 project will study how fidgeting relates to cognitive and emotional functioning in adults with attention-deficit/hyperactivity disorder (ADHD). It will determine, in a laboratory setting, whether movement and access to a "fidget device" providing sensory and motor stimulation can improve cognitive and emotional regulation (including on physiological measures) in adult ADHD. The investigators will also acquire pilot data for machine learning analyses to be used in future, large scale studies to identify gestures and touch characteristics associated with improved cognitive and emotional regulation to see if the data can predict and subsequently develop recommendations to improve performance and emotional control in natural settings (e.g., home, office, college classroom) for adult ADHD.

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.

Is the fidget ball safe for use in humans?

There have been reports of fidget spinners, a similar type of fidget toy, being ingested by children, which sometimes required medical intervention. This suggests a potential safety risk if not used properly, especially with young children. ^{1 2 3 4 5}

How does the Fidget Ball treatment for ADHD differ from other treatments?

The Fidget Ball treatment for ADHD is unique because it involves using a physical object to help improve focus and attention, similar to fidget spinners, which have been shown to increase on-task behavior in children with ADHD. Unlike traditional medications, this treatment provides a non-drug alternative that engages motor skills and activates brain areas associated with planning and reward. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Fidget Ball for ADHD?

Research on similar fidget toys, like fidget spinners, shows mixed results. 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 young children with ADHD. ^{1 2 3 5 8}

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

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, 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 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]

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]

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]

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]

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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Using Fidget Spinners to Improve On-Task Classroom Behavior for Students With ADHD. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Fidget spinners: Purported benefits, adverse effects and accepted alternatives. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Classroom seating for children with attention deficit hyperactivity disorder: therapy balls versus chairs. [2019]

4. United States 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. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Radiographic appearance and clinical significance of fidget spinner ingestions. [2019]

6. New Zealand 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. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Cortico-striatal activity associated with fidget spinner use: an fMRI study. [2023]

8. Australia pubmed.ncbi.nlm.nih.gov

Play preference of children with ADHD and typically developing children in Brazil: a pilot study. [2015]