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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038215
Receipt No. R000043560
Scientific Title Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial
Date of disclosure of the study information 2019/10/07
Last modified on 2021/04/19

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Basic information
Public title Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial
Acronym Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial
Scientific Title Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial
Scientific Title:Acronym Effectiveness of Family Inclusive Treatment program for OCD adolescents : Before-after trial
Region
Japan

Condition
Condition Obsessive Compulsive Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assess the effectiveness and safety of Family Inclusive Treatment program for OCD adolescents (FIT-O).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes CY-BOCS;Child Yale Brown Obsessive Compulsive Scale at the time of end of intervention period
Key secondary outcomes 1.FAS;Family Accommodation Scale
2.OFF;OCD Family Functioning Scale
3.CGI-S;Impairment
4.CGI-S;Improvement
5.CBCL;Child Behavior Checklist, YSR;Youth Self-Report

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Family Inclusive treatment program in addition to treatment as usual
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
12 years-old <=
Age-upper limit
17 years-old >=
Gender Male and Female
Key inclusion criteria OCD patient
1.Subjects with primary diagnosis of obsessive compulsive disorder by DSM-5.
2.Those who have 16 or more CY-BOCS
3.Aged 12 years or older, and younger than 17 years at screening.
4.Subjects who give consent with not to change current pharmacotherapy.
5.Subjects who give full consent in the participation of the study.

Patient's family
1. One family member living with the patient for at least one year at the time of screening. The family members are primarily responsible for childcare or are most involved in patient OCD.
2. Subjects who give full consent in the participation of the study.
Key exclusion criteria 1.No alcohol or substance use disorder in 6 months prior to the screening.
2.No other primary Disorders in 6 months prior to the screening.
3.No serious suicidal ideation at screening.
4.Patients with IQ less than 70
5.Persons who have adjusted their drugs for 12 weeks before screening
6.Patients who are difficult to visit 14 times after screening
7.Patients whose family members are difficult to participate in all five family program sessions during CBT
8.Those who have received CBT for structured obsessive-compulsive disorder by the time of screening
9.Those who have severe cognitive impairment that makes it difficult to perform CBT at the time of screening
10.Those who have a serious or unstable physical disease that is life-threatening in clinical diagnosis at the time of screening
11.Those who are deemed inappropriate by the research supervisor
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Tetsu
Middle name
Last name Hirosawa
Organization Kanazawa University
Division name Department of Psychiatry and Neurobiology
Zip code 920-8641
Address 13-1 Takara machi, Kanazawa City, Ishikawa Prefecture
TEL 076-265-2304
Email cbt_fit@yahoo.co.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Kontani
Organization Kanazawa University
Division name Department of Psychiatry and Neurobiology
Zip code 920-8641
Address 13-1 Takara machi, Kanazawa City, Ishikawa Prefecture
TEL 076-265-2304
Homepage URL
Email cbt_fit@yahoo.co.jp

Sponsor
Institute Kanazawa University
Department of Psychiatry and Neurobiology
Institute
Department

Funding Source
Organization Grant-in-Aid for Young Scientists
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 Kanazawa University
Address 13-1 Takara machi, Kanazawa City, Ishikawa Prefecture
Tel 076-265-2304
Email cbt_fit@yahoo.co.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 綾瀬メンタルクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 07 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 Open public recruiting
Date of protocol fixation
2019 Year 09 Month 01 Day
Date of IRB
2019 Year 10 Month 07 Day
Anticipated trial start date
2019 Year 10 Month 10 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Two out of twelve expected attendees has completed participation.

Management information
Registered date
2019 Year 10 Month 06 Day
Last modified on
2021 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043560

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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