Fidgeting and Attentional and Emotional Regulation in ADHD

Can Fidgeting Lead to Enhanced Attention and Emotional Regulation in ADHD?

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD
• Intervention / Treatment: Other: Fidget ball

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 Type: Interventional
• Enrollment (Estimated): 109
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jared Borden; Phone Number: 916-703-0294; Email: jborden@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis MIND Institute
      • Contact: Jared Borden; Phone Number: 916-703-0294; Email: jborden@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No fidget
Experimental: With fidget; The participant is given a specially designed fidget ball	Other: Fidget ball; Access to a prototype 'smart' fidget ball with pressure sensors embedded, that produces touch traces and transmits real time data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Processing speed	Paced Auditory Serial Addition Task (PASAT)	Day 1
Working memory	List Sorting Test	Day 1
Response inhibition	Flanker type test	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological response as an index of emotional regulation	Heart rate variability and pre ejection period	Approximately 45 minutes

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Julie Schweitzer, Ph.D., UC Davis MIND Institute

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1607722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared via NDAR
• IPD Sharing Time Frame: Undecided, likely after publication date
• IPD Sharing Access Criteria: Will be through NDAR
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No