UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000050196
Receipt number R000057169
Scientific Title Study of related factors in symptoms of adult attention-deficit/hyperactivity disorder
Date of disclosure of the study information 2023/02/01
Last modified on 2023/08/02 21:27:03

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Basic information

Public title

Study of related factors in symptoms of adult attention-deficit/hyperactivity disorder

Acronym

Study of related factors in adult ADHD

Scientific Title

Study of related factors in symptoms of adult attention-deficit/hyperactivity disorder

Scientific Title:Acronym

Study of related factors in symptoms of adult ADHD

Region

Japan


Condition

Condition

adult attention-deficit/hyperactivity disorder

Classification by specialty

Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary purpose is to compare the influence of factors such as parental care attitudes, attachment, and ADHD symptoms in childhood on the presence or absence of ADHD symptoms in adults. A secondary purpose is to examine the relationship between these factors and factors such as depression and busyness.

Basic objectives2

Others

Basic objectives -Others

Investigation of factors affecting the development of ADHD symptoms

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint is the difference in the effects of the WURS score, ECR-GO score, and PBI score on the presence or absence of adult ADHD symptoms.

Key secondary outcomes

Secondary endpoints are comparisons and studies of relationships among measures such as ASRS score, WURS score, ECR-GO score, PBI score, PHQ-9 score, and busyness questionnaire scores.


Base

Study type

Others,meta-analysis etc


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

18 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Those who understand the purpose of the research and can obtain written consent to participate in the research.
(2) Those who are 18 years old or older at the time of study participation.

Key exclusion criteria

None

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Hisae
Middle name
Last name Ono

Organization

Kwansei Gakuin University

Division name

Department of Integrated Psychological Sciences, School of Humanities

Zip code

662-8501

Address

1-155 Uegahara Ichibancho, Nishinomiya, Hyogo

TEL

0798544517

Email

hisaono@kwansei.ac.jp


Public contact

Name of contact person

1st name Hisae
Middle name
Last name Ono

Organization

Kwansei Gakuin University

Division name

Department of Integrated Psychological Sciences, School of Humanities

Zip code

662-8501

Address

1-155 Uegahara Ichibancho, Nishinomiya, Hyogo

TEL

0798544517

Homepage URL


Email

hisaono@kwansei.ac.jp


Sponsor or person

Institute

Kwansei University

Institute

Department

Personal name



Funding Source

Organization

Kwansei University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee for Life Science and Medical Research Involving Human Subjects

Address

Gakuen Uegahara 1 ban Sanda, Hyogo

Tel

0795659052

Email

med-ethic@kwansei.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



Other administrative information

Date of disclosure of the study information

2023 Year 02 Month 01 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

1017

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

No longer recruiting

Date of protocol fixation

2023 Year 01 Month 26 Day

Date of IRB

2023 Year 01 Month 26 Day

Anticipated trial start date

2023 Year 01 Month 31 Day

Last follow-up date

2026 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Online cross-sectional research


Management information

Registered date

2023 Year 01 Month 31 Day

Last modified on

2023 Year 08 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057169


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name