UMIN-CTR Clinical Trial

Basic information
Public title	Development of psychoeducational program for parents of a child with food allergy
Acronym	Development of psychoeducational program for parents of a child with food allergy
Scientific Title	Development of psychoeducational program for parents of a child with food allergy
Scientific Title:Acronym	Development of psychoeducational program for parents of a child with food allergy
Region	Japan

Condition
Condition	Parents of a child with food allergy
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To development and evaluate the efficacy of psychoeducational program for parents of a child with food allergy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in knowledges about food allergy and anxiety of parents of a child with food allergy before and after the psychoeducational program
Key secondary outcomes	Evaluate the psychoeducational program

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 Maneuver
Interventions/Control_1	The psychoeducational program contains the lecture and peer meeting(group therapy). One group has capacity of 5-8 persons. The program are held online session or face to face session. We ask parents participated in the program to fill out several questionnaires before and after the program to evaluate the efficacy.
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 a child with food allergy
Key exclusion criteria	nothing
Target sample size	50

Research contact person
Name of lead principal investigator	1st name REIKO Middle name Last name NAKAJIMA
Organization	Toyohashi Sozo University
Division name	School of Health Sciences Department of Nursing
Zip code	440-8511
Address	20-1 Matsushita,Ushikawa-cho,Toyohashi-City,Aichi
TEL	05020172295
Email	r-nakajima@sozo.ac.jp

Public contact
Name of contact person	1st name REIKO Middle name Last name NAKAJIMA
Organization	Toyohashi Sozo University
Division name	School of Health Sciences Department of Nursing
Zip code	440-8511
Address	20-1 Matsushita,Ushikawa-cho,Toyohashi-City,Aichi
TEL	05020172295
Homepage URL
Email	r-nakajima@sozo.ac.jp

Sponsor
Institute	Toyohashi Sozo University
Institute
Department

Funding Source
Organization	Japan Society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Toyohashi Sozo University Research Ethics Committee
Address	20-1 Matsushita,Ushikawa-cho,Toyohashi-City,Aichi
Tel	05020172295
Email	r-nakajima@sozo.ac.jp

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	2022 Year 09 Month 28 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	Enrolling by invitation
Date of protocol fixation	2020 Year 03 Month 19 Day
Date of IRB	2020 Year 03 Month 19 Day
Anticipated trial start date	2021 Year 12 Month 21 Day
Last follow-up date	2023 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	2022 Year 09 Month 28 Day
Last modified on	2022 Year 09 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055881