Fidgeting and Attentional and Emotional Regulation in ADHD

Not Applicable

Recruiting

• Conditions: ADHD
• Interventions: Other: Fidget ball

• Registration Number: NCT04526600
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

Fidgeting is a highly common behavior, with excessive fidgeting associated with attention-deficit/hyperactivity disorder (ADHD). Studies from the investigator's laboratory and colleagues suggest physical movement can enhance cognitive performance in children with ADHD. Hyper-sensorimotor behavior may be related to impaired regulation of arousal in the noradrenergic and dopaminergic systems. This project will assess if frequency and characteristics of sensorimotor behavior relates to cognitive and emotional response in adults with ADHD, in a fine-grained manner, unlike other studies. The investigators will test if intrinsic fidgeting (Aim 1) and access to a specially designed fidget device (Aim 2) modulates behavioral and physiological response in cognitively and emotionally-demanding contexts. The hype of the commercially available fidget devices, its competitors and fidget spinners suggest it might, but there is no systematic evidence to inform consumers, a gap, the investigators aim to fill.

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-26
• Study Start: 2022-03-21
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12
• Primary Completion: 2024-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

• ADHD
• History of fidgeting

Exclusion Criteria

• Currently taking psychoactive medication, with the exception of stimulant medication for ADHD or medication that can affect heart rate;
• Presence of significant depression or psychotic disorders, autism, visual or hearing impairment or any other disorder that may interfere with task performance; and IQ below 85

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With fidget	Fidget ball	The participant is given a specially designed fidget ball

Primary Outcome Measures

Name	Time	Method
Processing speed	Day 1	Paced Auditory Serial Addition Task (PASAT)
Working memory	Day 1	List Sorting Test
Response inhibition	Day 1	Flanker type test

Secondary Outcome Measures

Name	Time	Method
Physiological response as an index of emotional regulation	Approximately 45 minutes	Heart rate variability and pre ejection period

Trial Locations

Locations (1)

UC Davis MIND Institute; 🇺🇸 Sacramento, California, United States