Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Hyperactivity Assessment in Children With Attention-deficit Hyperactivity Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05810636
• Other study ID #: 202110059RINB
• Status: Enrolling by invitation
• Start date: February 16, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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)
• Unable to use smartwatch and smartphone 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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Device:
• Garmin Vivosmart wearable device
Wearing smartwatches to collect data

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (16)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceleration	Arm Acceleration	24 hours for 30 days