UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Team approach for prevention, treatment, and recovery of PTSD due to violence victimization: Effectiveness of CBT for individual, parent-child, and family.
Title of the study (Brief title)	Effectiveness of CBT on PTSD for individual, parent-child, and family
Region	Japan

Condition
Condition	Post traumatic stress disorder
Classification by specialty	Psychosomatic Internal Medicine Psychiatry Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is to examine the effectiveness of CBT on PTSD for individual, parent-child, and family provided by the PTSD prevention, treatment, and recovery team.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PTSD Diagnosis, Symptoms of PTSD,depression, and dissociation Child behavioral problems Parental difficulties and stress
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom Maneuver Other
Interventions/Control_1	Conduct Prolonged exposure therapy (PE)on individuals, Parent-Child Interaction Therapy(PCIT) on parent and child, and psycho-education on family.
Interventions/Control_2	PE waiting PCIT waiting
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	PE: a.Male and Female aged 20 years and over. b.Suffering PTS symptoms with and without diagnosis of PTSD c.Remember and tell traumatic experience d.Willingly participate in this study e.Primary doctor's agreement PCIT a.Parent or caregiver who fosters children from 2 and a half to 7 years of age. b.Child has behavioral problems including disruptive behaviors. c.Could continuously comply to this treatment schedule d.Willingly participate in this study e.Primary doctor's agreement
Key exclusion criteria	PE a.Have risk of harm self and others compulsively. b.Have severe self-harm behaviors c.Have current psychosis d.Have risk of being revictimization e.Almost no trauma memory f.Minor aged under 20 years g.No agreement of primary doctor PCIT a.Children aged under 2 and a half years or 7 years over, and their parents and caregivers. b.Could not comply the treatment schedule c.Required to priorities other intervention than PCIT d.No agreement of primary doctor
Target sample size	60

Research contact person
Name of lead principal investigator	Miyoko Nagae
Organization	Nihon Fukushi University
Division name	Faculty of Nursing School
Address	229 Kawaminamishinden, Ota-machi, Tokai-shi, Aichi-ken 477-0031, JAPAN
TEL	0562-39-3811
Email	mnagae1@gmail.com

Public contact
Name of contact person	Research Ethics Board
Organization	Nihon Fukushi University
Division name	Research Department
Address	229 Kawaminamishinden, Ota-machi, Tokai-shi, Aichi-ken 477-0031, JAPAN
TEL	0562-39-3811
Homepage URL
Email	rinri@ml.n-fukushi.ac.jp

Sponsor
Institute	Nihon Fukushi University
Institute
Department

Funding Source
Organization	Japanese Society for the Promotion of Science KAKENHI Grant in Aid for Scientific Research B
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 16 Day
Last modified on	2018 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037181