UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029014 |
|---|---|
| Receipt number | R000033174 |
| Scientific Title | Analysis of WISC-IV Cognitive Profile in children with Developmental disability and evaluation of the relationships between WISC-IV Cognitive Profile and effects of pharmacotherapy |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2024/03/11 09:35:43 |
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Basic information
Public title
Analysis of WISC-IV Cognitive Profile in children with Developmental disability and evaluation of the relationships between WISC-IV Cognitive Profile and effects of pharmacotherapy
Acronym
Analysis of WISC-IV Cognitive Profile in children with Developmental disability
Scientific Title
Analysis of WISC-IV Cognitive Profile in children with Developmental disability and evaluation of the relationships between WISC-IV Cognitive Profile and effects of pharmacotherapy
Scientific Title:Acronym
Analysis of WISC-IV Cognitive Profile in children with Developmental disability
Region
| Japan |
Condition
Condition
Developmental disability
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate association between WISC-IV Cognitive Profile and clinical perspective in children with Developmental disability in our institute and to examine relationship the variation of WISC-IV Cognitive Profile and clinical course by therapeutic interventions and pharmacotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Wechsler Intelligence Scale for Children-IV (WISC-IV): Full Scale IQ Verbal. Comprehension Index(Similarities, Vocabulary, and Comprehension). Perceptual Reasoning Index (Block Design, Picture Concepts, and Matrix Reasoning). Working Memory Index (Digit Span and Letter-Number Sequencing). Processing Speed Index (Coding and Symbol Search). Medication information (drug information, dose of medication, dosing period, initial date for medication), Clinical symptom resulted from characteristics of developmental disability.
Key secondary outcomes
patient characteristics:Date of birth, sex, past history, birth weight
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| 17 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1:All participants has been examined the Wechsler Intelligence Scale for Children-IV (WISC-IV)at the outpatients of Fukuchiyama city hospital from April 2012 to March 2017.
2:All participants who aged 6-16 years old at the age of the enforcement of WISC-IV.
3:All participants who have >70 of Full Scale IQ from the results of WISC-IV.
4:All participants who have been diagnosed as either ADHD or ASD or LD. The overlap of these diagnoses is permitted.
5:2 and 3 are to exclude the influence on immaturity of the development and cognitive characteristic by intellectual disability. The value to divide whether it is intellectual disability is IQ70.
Key exclusion criteria
N/A
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Iwahashi |
Organization
Fukuchiyama City Hospital
Division name
Department of Psychiatry
Zip code
620-8505
Address
231 Atsunaka-cho, Fukuchiyama-City, Kyoto
TEL
0773222101
kuwahara@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Iwahashi |
Organization
Fukuchiyama City Hospital
Division name
Department of Psychiatry
Zip code
620-8505
Address
231 Atsunaka-cho, Fukuchiyama-City, Kyoto
TEL
0773222101
Homepage URL
kuwahara@koto.kpu-m.ac.jp
Sponsor or person
Institute
Fukuchiyama city Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuchiyama city Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto Prefectural University of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuchiyama City Hospital
Address
231 Atsunaka-machi Fukuchiyama-shi Kyoto-fu
Tel
0773222101
kuwahara@koto.kpu-m.ac.jp
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
市立福知山市民病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.city.fukuchiyama.lg.jp/site/hosp/2976.html
Publication of results
Published
Result
URL related to results and publications
https://www.city.fukuchiyama.lg.jp/site/hosp/2976.html
Number of participants that the trial has enrolled
138
Results
The ASD-ADHD group exhibited lower trends in Working Memory Index (WMI) and Processing Speed Index (PSI), indicating significant profile deviations and potential cognitive impacts.
Results date posted
| 2024 | Year | 03 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The analysis included 138 cases that visited the Municipal Fukuchiyama Hospital due to some developmental issue, birth anomaly, or disorder affecting development between April 2012 and March 2018 and underwent WISC-IV assessment. Among them, 96 subjects with FSIQ scores of 70 or above who received a diagnosis of either ASD or ADHD based on DSM-5 criteria were selected for analysis. Furthermore, they were divided into groups of subjects who received a single diagnosis without comorbidity (hereafter referred to as ASD group and ADHD group) and those who received a comorbid diagnosis of ASD and ADHD (hereafter referred to as ASD-ADHD comorbid diagnosis group). The breakdown of subjects is shown in Table 1. The ASD group consisted of 46 individuals (29 boys, 17 girls) with an average chronological age at assessment of 10 years and 4 months. The ADHD group comprised 36 individuals (32 boys, 4 girls) with an average chronological age at assessment of 10 years and 7 months. The ASD-ADHD comorbid diagnosis group included 14 individuals (13 boys, 1 girl) with an average chronological age at assessment of 10 years and 10 months. Subjects diagnosed with epilepsy or other disorders in addition to ASD or ADHD were also included in the analysis. Subjects who were assessed before the revision to DSM-5 were classified based on DSM-5 criteria after diagnosis.
Participant flow
We extracted 138 individuals who underwent the WISC-IV assessment. Among them, we selected 96 individuals with an FSIQ of 70 or above who received a diagnosis of either ASD or ADHD based on the DSM-5 diagnostic criteria for analysis.
Adverse events
None
Outcome measures
We calculated the mean, standard deviation (SD), and 95% confidence intervals for the FSIQ and the four indexes, as well as the mean and SD for the 10 subtests of the WISC-IV in each group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
All participants has been examined The Wechsler Intelligence Scale for Children-IV (WISC-IV)at the outpatients of Fukuchiyama city hospital from April 2012 to March 2017.
Management information
Registered date
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033174
