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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029331
Receipt No. R000033359
Scientific Title A study on the supporting method for caregivers of children with developmental disorders utilizing the Emotional Availability Scales (EAS)
Date of disclosure of the study information 2017/11/01
Last modified on 2017/09/28

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Basic information
Public title A study on the supporting method for caregivers of children with developmental disorders utilizing the Emotional Availability Scales (EAS)
Acronym S study on supporting method for caregivers with EAS
Scientific Title A study on the supporting method for caregivers of children with developmental disorders utilizing the Emotional Availability Scales (EAS)
Scientific Title:Acronym S study on supporting method for caregivers with EAS
Region
Japan

Condition
Condition Autism Spectrum Disorder, Attention-Deficit/Hyperactivity Disorder
Classification by specialty
Psychiatry Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify qualitatively utility and efficacy of a supporting method for caregivers of children with developmental disorders utilizing the Emotional Availability Scales
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The result of synthesis of the recorded data of the answers to questions to ask what changes
occurred after the intervention with Emotional Availability Scales utilizing the KJ method at the time-point of 4 months after the first intervention
Key secondary outcomes "Adult sensitivity", "adult structuring", "adult nonintrusiveness", "adult nonhostility", "child responsiveness to the adult", "child involvement of the adult" in the Emotional Availability Scales at the time-point of 4 months after the first intervention

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 In the first session, the caregivers are interviewed on the behavioral problems of the children and and their familial situations and their interactions with the children in free play are recorded. The duration of will be 60-75 minutes.
Two week after the first session, the video records were shown to the caregivers and explanation about the result of evaluation of the EAS are given to them. Then the researchers gave them advice on how to relate to the children. The duration will be 45-65 minutes.
Two months after the first session, the caregivers are interviewed on the present behaviors of the children. The duration will be 20-30 minutes.
Four months after the first session, the interactions between the caregivers and the children are recorded on video again, and the caregivers are interviewed on the effect of these interventions. The duration will be 45-60 minutes. Thus, the duration of all of these interventions is 4 months.
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
3 years-old <=
Age-upper limit
10 years-old >=
Gender Male and Female
Key inclusion criteria Th children of 3-10 years old who are diagnosed with autism spectrum disorder, pervasive developmental disorders, Asperger disorder, autistic disorder and attention deficit/ hyperactivity disorder and their caregivers are recruited in a clinic and a counseling center.
Key exclusion criteria Children with severe physical diseases are excluded from the subjects.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Arata Oiji
Organization Kitasato University
Division name Graduate School of Medical Science
Zip code
Address 1-15-1 Kitasato, Minami Ku, Sagamihara City, Kanagawa Prefecture
TEL +81427787957
Email aoiji@kitaasto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Arata Oiji
Organization Kitasato University
Division name Graduate School of Medical Science
Zip code
Address 1-15-1 Kitasato, Minami Ku, Sagamihara City, Kanagawa Prefecture
TEL +81427787957
Homepage URL
Email aoiji@kitaasto-u.ac.jp

Sponsor
Institute Graduate School of Medical Science, Kitasato University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 北里大学附属臨床心理相談センター、まめの木クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 11 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
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
2017 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 05 Month 31 Day
Date analysis concluded
2022 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 28 Day
Last modified on
2017 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033359

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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