UMIN-CTR Clinical Trial

Basic information
Public title	Development of a stress intervention program for parents of children living with milk allergy.
Acronym	Stress intervention program for the parents of children with milk allergy.
Scientific Title	Development of a stress intervention program for parents of children living with milk allergy.
Scientific Title:Acronym	Stress intervention program for the parents of children with milk allergy.
Region	Japan

Condition
Condition	Milk allergy
Classification by specialty	Hematology and clinical oncology Adult Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will investigate the effectiveness of psychoeducation for the parents of children living with milk allergy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mental health of parents
Key secondary outcomes

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	psychoeducation group
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Parents of children living with milk allergy. Children are 3 to 5 years old.
Key exclusion criteria	Not parents of children living with milk allergy.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mizuho Konishi
Organization	National Center for Child Health and Development
Division name	Department of Medical Specialties
Zip code
Address	2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, JAPAN
TEL	+81(3)34160181
Email	konishi-m@ncchd.go.jp

Public contact
Name of contact person	1st name Middle name Last name Mizuho Konishi
Organization	National Center for Child Health and Development
Division name	Department of Medical Specialties
Zip code
Address	2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, JAPAN
TEL	81-334160181
Homepage URL
Email	konishi-m@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Funding Source
Organization	Japan Dairy Association (J-milk)
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 11 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Completed
Date of protocol fixation	2014 Year 05 Month 29 Day
Date of IRB	2014 Year 05 Month 09 Day
Anticipated trial start date	2014 Year 06 Month 23 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 11 Day
Last modified on	2019 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016524