UMIN-CTR Clinical Trial

Basic information
Public title	The research for Psycho-educational program named "Families In Transition" for university students who have experienced parents' divorce while they were under 20
Acronym	The research for Psycho-educational program named "Families In Transition" for university students who have experienced parents' divorce while they were under 20
Scientific Title	The research for Psycho-educational program named "Families In Transition" for university students who have experienced parents' divorce while they were under 20
Scientific Title:Acronym	The research for Psycho-educational program named "Families In Transition" for university students who have experienced parents' divorce while they were under 20
Region	Japan

Condition
Condition	adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to examine the effect of psycho-educational program named "Families In Transition" for university students who experienced parents' divorce while they were young.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hormone in the saliva (cortisol etc)
Key secondary outcomes	Stress Response Scale:SRS-18 Interview

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
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	Psycho-educational program
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	University student who experienced parents' divorce while they were under twenty
Key exclusion criteria	under 20 years old
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Tetsuko Middle name Last name Yamada
Organization	Rikkyo University
Division name	College of Contemporary psychology
Zip code	3528558
Address	1-2-26 Kitano, Niiza-city, Saitama, 352-8558
TEL	0484717049
Email	tyamad@rikkyo.ac.jp

Public contact
Name of contact person	1st name Tetsuko Middle name Last name Yamada
Organization	Rikkyo University
Division name	College of Contemporary psychology
Zip code	3528558
Address	1-2-26 Kitano, Niiza-city, Saitama, 352-8558
TEL	0484717049
Homepage URL
Email	tyamad@rikkyo.ac.jp

Sponsor
Institute	Rikky University
Institute
Department

Funding Source
Organization	MEXT(Japan)
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	Rikkyo University
Address	3-34-1, Nishiikebukuro, Toshima-ku, Tokyo, 171-8501
Tel	0339854674
Email	lifescience@rikkyo.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	2019 Year 07 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	Completed
Date of protocol fixation	2019 Year 05 Month 24 Day
Date of IRB	2019 Year 04 Month 26 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 07 Month 01 Day
Last modified on	2022 Year 08 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042436