UMIN-CTR Clinical Trial

Basic information
Public title	Examination of predictors of development into truancy and withdrawal by salivary stress biomarkers in children with developmental disorders
Acronym	Examination of predictors of development into truancy and withdrawal by salivary stress biomarkers in children with developmental disorders
Scientific Title	Examination of predictors of development into truancy and withdrawal by salivary stress biomarkers in children with developmental disorders
Scientific Title:Acronym	Examination of predictors of development into truancy and withdrawal by salivary stress biomarkers in children with developmental disorders
Region	Japan

Condition
Condition	Autism spectrum disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine whether psychological characteristics and salivary stress biomarkers and head MRI are different among children with developmental disabilities such as Autism Spectrum Disorder (ASD) and Attention Deficit/Hyperactivity Disorder (ADHD) who do not attend school or are withdrawn from school, children with developmental disabilities who do not attend school or are withdrawn from school, and healthy controls. We will determine whether psychological characteristics, salivary stress biomarkers, and head MRI are different between children with developmental disorders such as ASD and Attention Deficit/Hyperactivity Disorder (ADHD), children with developmental disorders who do not attend school and are withdrawn, and healthy controls. In addition, how do psychological characteristics, salivary stress biomarkers, and head MRI change in children with developmental disabilities who do not attend school or withdraw from school, whether salivary stress biomarkers are related to psychological characteristics, and what are the characteristics of children who later develop into truants or withdrawers? To clarify the relationship between salivary stress biomarkers and psychological characteristics, and how they are characterized in later development of truancy and withdrawal. Translated with www.DeepL.com/Translator (free version)
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Strong factors as causes of truancy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Questionnaire
Interventions/Control_2	head MRI
Interventions/Control_3	saliva collection
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) ASD group Patients diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and ADOS2. (2) ADHD group Patients diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). (3) Control group (HC) Healthy control subjects whose age and gender match those of the ASD and ADHD groups (assessed by the non-patient version of the Structured Interview for DSM-IV (SCID)). Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria	(1) Patients with a history of head trauma with impaired consciousness, chronic lung disease, renal disease, chronic liver disease, thyroid disease, active cancer, cerebrovascular disease, epilepsy, neurological disease, or substance-related disorders (2) Patients with autoimmune diseases (SLE, hyperthyroidism: Graves' disease, ulcerative colitis, Crohn's disease, etc.) (3) Those with a verbal comprehension index of <70 on the Wechsler Intelligence Scale for Children (WISC) or the Wechsler Adult Intelligence Scale (WAIS) (4) Patients with a clear history of psychotic symptoms (5) Patients who regularly use steroids and NSAIDs Translated with www.DeepL.com/Translator (free version)
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kazuhiko Middle name yamamuro Last name Yamamuro
Organization	Nara Medical University
Division name	Psychiatry
Zip code	634-8522
Address	840, shijyo-cho, Kashihara city, Nara
TEL	0744223051
Email	muro@naramed-u.ac.jp

Public contact
Name of contact person	1st name kazuhiko Middle name Last name Yamamuro
Organization	Nara Medical University
Division name	Psychiatry
Zip code	634-8522
Address	840, shijyo-cho, Kashihara city, Nara
TEL	0744-22-3051
Homepage URL
Email	muro@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Pfizer Health Research
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Not applicable
Address	Not applicable
Tel	Not applicable
Email	Not applicable

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2020 Year 07 Month 08 Day
Date of IRB	2020 Year 07 Month 08 Day
Anticipated trial start date	2020 Year 07 Month 08 Day
Last follow-up date	2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 12 Month 18 Day
Last modified on	2021 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052956