UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the supporting method for caregivers of children with developmental disorders utilizing the Emotional Availability Scales (EAS)
Title of the study (Brief title)	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	Arata Oiji
Organization	Kitasato University
Division name	Graduate School of Medical Science
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	Arata Oiji
Organization	Kitasato University
Division name	Graduate School of Medical Science
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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