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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033008
Receipt No. R000037612
Scientific Title A study on the effect of delayed auditory feedback on speech production of developmental disorder
Date of disclosure of the study information 2018/06/18
Last modified on 2018/06/15

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Basic information
Public title A study on the effect of delayed auditory feedback on speech production of developmental disorder
Acronym Effect of delayed auditory feedback on speech of developmental disorder
Scientific Title A study on the effect of delayed auditory feedback on speech production of developmental disorder
Scientific Title:Acronym Effect of delayed auditory feedback on speech of developmental disorder
Region
Japan

Condition
Condition Developmental disorder, typically developed controls
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The study examines whether and how heterogeneity exists in dysfluent speech in developmental disorder by analyzing the acoustic features of speech produced under the delayed auditory feedback (DAF) in neurodevelopmental disorder of autism spectrum disorder (ASD) and attention deficits and hyperactivity disorder (ADHD).
Basic objectives2 Others
Basic objectives -Others The study also examine whether DAF is effective in facilitating speech in ASD and ADHD. We evaluate the speed, correctly pronounced moras, format structures and compare the effect of DAF among ASD, ADHD, and controls.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - Reading aloud task under DAF
Key secondary outcomes - Standard test for Stuttering
- Hearing test
- AQ
- CAARS
- JART
- Edinburgh Handedness test
- Questionnaire for basic information
- OASES-A
- Questionnaire for speech

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 Diagnosis
Type of intervention
Behavior,custom
Interventions/Control_1 Speech test
Interventions/Control_2 Speech test
Interventions/Control_3 Speech test
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria ASD group
1) Subjects who had received a clinical diagnosis of ASD in outpatient units of the Showa University Karasuyama Hospital
2) No serious comorbid psychiatric disorders or medical illness.
3) Capability of informed consent
4) Aged 20-49 years-old, male and female, who satisfy all the criteria of 1)-3).

ADHD group
1) Subjects who had received a clinical diagnosis of ADHD in outpatient units of the Showa University Karasuyama Hospital
2) No serious comorbid psychiatric disorders or medical illness.
3) Capability of informed consent
4) Aged 20-49 years-old, male and female, who satisfy all the criteria of 1)-3).

Healthy group
1) No serious psychiatric disorders or medical illness.
2) Capability of informed consent
3) Aged 20-49 years-old, male and female
Key exclusion criteria Subjects who are judged as unsuitable for participation in this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuichiro Hashimoto
Organization Showa University
Division name Medical Institute of Developmental Disabilities Research
Zip code
Address 6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL 03-5315-9357
Email ihashimoto-r@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryuichiro Hashimoto
Organization Showa University
Division name Medical Institute of Developmental Disabilities Research
Zip code
Address 6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL 03-5315-9357
Homepage URL
Email ihashimoto-r@umin.ac.jp

Sponsor
Institute Showa University
Institute
Department

Funding Source
Organization Showa University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 06 Month 18 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 15 Day
Last modified on
2018 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037612

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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