UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029331 |
|---|---|
| Receipt number | 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 13:54:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
aoiji@kitaasto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Science, Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033359
