Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder

NCT05810636 | Unknown

• 1 other identifier: 202110059RINB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. Clinical diagnosis of this disorder depends of history taking, parent report, and questionnaire. Attention test such as continuous performance test can provide quantitative measurement on attention deficits; however, there is a lack of objective tool to quantify the activity level. This study aims to assess activity level in children with ADHD. We plan to recruit 50 children with ADHD and 50 neurotypical children. The activity level measured by wearable device will be compared between ADHD and neurotypical children. The correlation between behavior rating on questionnaire and quantitative data measured by wearable device will be analyzed.

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

• Acceleration

  Arm Acceleration

  24 hours for 30 days

Study Arms (2)

ADHD group

Inclusion criteria: * DSM-5 Attention-deficit hyperactivity disorder * 7\~18 years old * Willing to carry smartwatch and smartphone most of the time during one-month study period Exclusion criteria: \- Comorbid with major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder)

Device: Garmin Vivosmart wearable device

Neurotypical group

Inclusion criteria: * 7\~18 years old without a diagnosis of Attention-deficit hyperactivity disorder * Willing to carry smartwatch and smartphone most of the time during one-month study period Exclusion criteria: * Have a diagnosis of major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder) * Unable to use smartwatch and smartphone

Device: Garmin Vivosmart wearable device

Interventions

Garmin Vivosmart wearable device DEVICE

Wearing smartwatches to collect data

ADHD group; Neurotypical group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Students from 1st grade to 12th grade who are eligible based on the criteria.

You may qualify if:

• DSM-5 Attention-deficit hyperactivity disorder
• \~18 years old
• Willing to carry smartwatch and smartphone most of the time during one-month study period

You may not qualify if:

• Comorbid with major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder)
• Unable to use smartwatch and smartphone
• Neurotypical group:
• \~18 years old without a diagnosis of Attention-deficit hyperactivity disorder
• Willing to carry smartwatch and smartphone most of the time during one-month study period
• Have a diagnosis of major psychiatric disorders (i.e., schizophrenia, bipolar disorder) or neurodevelopmental disorders (i.e., intellectual disability, autism spectrum disorder)
• Unable to use smartwatch and smartphone

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Related Publications (16)

• Burton C, McKinstry B, Szentagotai Tatar A, Serrano-Blanco A, Pagliari C, Wolters M. Activity monitoring in patients with depression: a systematic review. J Affect Disord. 2013 Feb 15;145(1):21-8. doi: 10.1016/j.jad.2012.07.001. Epub 2012 Aug 4.

  PMID: 22868056 BACKGROUND

• Cho CH, Lee T, Kim MG, In HP, Kim L, Lee HJ. Mood Prediction of Patients With Mood Disorders by Machine Learning Using Passive Digital Phenotypes Based on the Circadian Rhythm: Prospective Observational Cohort Study. J Med Internet Res. 2019 Apr 17;21(4):e11029. doi: 10.2196/11029.

  PMID: 30994461 BACKGROUND

• Couronne R, Probst P, Boulesteix AL. Random forest versus logistic regression: a large-scale benchmark experiment. BMC Bioinformatics. 2018 Jul 17;19(1):270. doi: 10.1186/s12859-018-2264-5.

  PMID: 30016950 BACKGROUND

• Dogan E, Sander C, Wagner X, Hegerl U, Kohls E. Smartphone-Based Monitoring of Objective and Subjective Data in Affective Disorders: Where Are We and Where Are We Going? Systematic Review. J Med Internet Res. 2017 Jul 24;19(7):e262. doi: 10.2196/jmir.7006.

  PMID: 28739561 BACKGROUND

• Gau SS, Chen SJ, Chou WJ, Cheng H, Tang CS, Chang HL, Tzang RF, Wu YY, Huang YF, Chou MC, Liang HY, Hsu YC, Lu HH, Huang YS. National survey of adherence, efficacy, and side effects of methylphenidate in children with attention-deficit/hyperactivity disorder in Taiwan. J Clin Psychiatry. 2008 Jan;69(1):131-40. doi: 10.4088/jcp.v69n0118.

  PMID: 18312048 BACKGROUND

• Gau SS, Lin CH, Hu FC, Shang CY, Swanson JM, Liu YC, Liu SK. Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, Version IV Scale-Teacher Form. J Pediatr Psychol. 2009 Sep;34(8):850-61. doi: 10.1093/jpepsy/jsn133. Epub 2008 Dec 12.

  PMID: 19074488 BACKGROUND

• Gau SS, Shang CY, Liu SK, Lin CH, Swanson JM, Liu YC, Tu CL. Psychometric properties of the Chinese version of the Swanson, Nolan, and Pelham, version IV scale - parent form. Int J Methods Psychiatr Res. 2008;17(1):35-44. doi: 10.1002/mpr.237.

  PMID: 18286459 BACKGROUND

• Leikauf JE, Correa C, Bueno AN, Sempere VP, Williams LM. StopWatch: Pilot study for an Apple Watch application for youth with ADHD. Digit Health. 2021 Apr 1;7:20552076211001215. doi: 10.1177/20552076211001215. eCollection 2021 Jan-Dec.

  PMID: 33868703 BACKGROUND

• Martin JL, Hakim AD. Wrist actigraphy. Chest. 2011 Jun;139(6):1514-1527. doi: 10.1378/chest.10-1872.

  PMID: 21652563 BACKGROUND

• Marzano L, Bardill A, Fields B, Herd K, Veale D, Grey N, Moran P. The application of mHealth to mental health: opportunities and challenges. Lancet Psychiatry. 2015 Oct;2(10):942-8. doi: 10.1016/S2215-0366(15)00268-0. Epub 2015 Sep 29.

  PMID: 26462228 BACKGROUND

• Patel MS, Foschini L, Kurtzman GW, Zhu J, Wang W, Rareshide CAL, Zbikowski SM. Using Wearable Devices and Smartphones to Track Physical Activity: Initial Activation, Sustained Use, and Step Counts Across Sociodemographic Characteristics in a National Sample. Ann Intern Med. 2017 Nov 21;167(10):755-757. doi: 10.7326/M17-1495. Epub 2017 Sep 26. No abstract available.

  PMID: 28973116 BACKGROUND

• Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry. 2007 Jun;164(6):942-8. doi: 10.1176/ajp.2007.164.6.942.

  PMID: 17541055 BACKGROUND

• Reinertsen E, Clifford GD. A review of physiological and behavioral monitoring with digital sensors for neuropsychiatric illnesses. Physiol Meas. 2018 May 15;39(5):05TR01. doi: 10.1088/1361-6579/aabf64.

  PMID: 29671754 BACKGROUND

• Simon V, Czobor P, Balint S, Meszaros A, Bitter I. Prevalence and correlates of adult attention-deficit hyperactivity disorder: meta-analysis. Br J Psychiatry. 2009 Mar;194(3):204-11. doi: 10.1192/bjp.bp.107.048827.

  PMID: 19252145 BACKGROUND

• Swanson JM, Kraemer HC, Hinshaw SP, Arnold LE, Conners CK, Abikoff HB, Clevenger W, Davies M, Elliott GR, Greenhill LL, Hechtman L, Hoza B, Jensen PS, March JS, Newcorn JH, Owens EB, Pelham WE, Schiller E, Severe JB, Simpson S, Vitiello B, Wells K, Wigal T, Wu M. Clinical relevance of the primary findings of the MTA: success rates based on severity of ADHD and ODD symptoms at the end of treatment. J Am Acad Child Adolesc Psychiatry. 2001 Feb;40(2):168-79. doi: 10.1097/00004583-200102000-00011.

  PMID: 11211365 BACKGROUND

• Tazawa Y, Wada M, Mitsukura Y, Takamiya A, Kitazawa M, Yoshimura M, Mimura M, Kishimoto T. Actigraphy for evaluation of mood disorders: A systematic review and meta-analysis. J Affect Disord. 2019 Jun 15;253:257-269. doi: 10.1016/j.jad.2019.04.087. Epub 2019 Apr 22.

  PMID: 31060012 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 12, 2023
• Study Start: February 16, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)