UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046413 |
|---|---|
| Receipt number | R000052956 |
| Scientific Title | Examination of predictors of development into truancy and withdrawal by salivary stress biomarkers in children with developmental disorders |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2021/12/18 22:31:48 |
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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as Autism Spectrum Disorder (ASD) and Attention Deficit/Hyperactivity Disorder (ADHD) who do not attend school or are withdrawn from school, children with developmental disabilities who do not attend school or are withdrawn from school, and healthy controls.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Attention Deficit/Hyperactivity Disorder (ADHD), children with developmental disorders who do not attend school and are withdrawn, and healthy controls.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
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
muro@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052956
