UMIN-CTR Clinical Trial

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

Developmental disability

Classification by specialty

Pediatrics

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

kuwahara@koto.kpu-m.ac.jp

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

Email

kuwahara@koto.kpu-m.ac.jp

Institute

Fukuchiyama city Hospital

Institute

Department

Personal name

Organization

Fukuchiyama city Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Kyoto Prefectural University of Medicine

Name of secondary funder(s)

Organization

Fukuchiyama City Hospital

Address

231 Atsunaka-machi Fukuchiyama-shi Kyoto-fu

Tel

0773222101

Email

kuwahara@koto.kpu-m.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

市立福知山市民病院

Date of disclosure of the study information

2017

Year

11

Month

01

Day

URL releasing protocol

https://www.city.fukuchiyama.lg.jp/site/hosp/2976.html

Publication of results

Published

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

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 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.

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