UMIN-CTR Clinical Trial

Basic information
Public title	Study on the efficacy of the Combined Parent-Child Cognitive Behavioral Therapy for child and their families at risk of physical abuse
Acronym	Study on the efficacy of the CPC-CBT for child and families at risk of physical abuse
Scientific Title	Quasi-experimental sudy on the efficacy of the Combined Parent-Child Cognitive Behavioral Therapy (CPC-CBT) for child and their families at risk of physical abuse
Scientific Title:Acronym	Quasi-experimental study of the CPC-CBT for families at risk of child physical abuse
Region	Japan

Condition
Condition	Physical punishment and/or coercive discipline
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy of the CPC-CBT for families at risk of child physical abuse by comparing the outcome of the groups of CPC-CBT and Waiting List Group, with the quasi-experimental design and assessment of the quality of parenting at pre and post treatment
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The quality of parenting mesured by the Alabama Parenting Questionnaire at pre and post treatment
Key secondary outcomes	Positive and negative parenting measured by the PNPS, Depressive symptoms of caregivers measured by BDI-2, Depression/anxiety/anger/PTSD symptoms/dissociation of children measured by TSCC-A, Emotional and behavioral problems of children measured by SDQ

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	Maneuver
Interventions/Control_1	CPC-CBT(16 sessions)
Interventions/Control_2	Waiting List(16weeks)
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	4 years-old <=
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	1.Child aged from 4 to under 18 years old with physically abused experiences. 2.The child has been separated from his/her parents and under the foster care system. 3.Caregivers and the child, including physical abuse perpetrators, can participate in treatment.
Key exclusion criteria	The following conditions are recognized in the child and/or caregivers. 1.Comorbidity of active psychotic symptoms and/or substance abuse. 2.Presence of severe depressive symptoms and/or self-injurious behaviors. 3.Presence of severe self-injury and others injury. 4.Presence of oppositional attitude, aggression and/or illegal actions. 5.Apparent developmental disorder or severe mental retardation. 6.Receiving psychotherapy outside of the study. 7.Caregiver is a perpetrator of sexual abuse for the child. 8.Presence of domestic violence in the family. 9.Presence of severe PTSD symptoms of the child.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Satomi Middle name Last name Kameoka
Organization	Hyogo Institute for Traumatic Stress
Division name	Research Division
Zip code	651-0073
Address	1-3-2, Wakinohama-Kaigandori, Chuoku, Kobe, Hyogo, 651-0073, JAPAN
TEL	078-200-3010
Email	kameoka@j-hits.org

Public contact
Name of contact person	1st name Satomi Middle name Last name Kameoka
Organization	Hyogo Institute for Traumatic Stress
Division name	Research Division
Zip code	651-0073
Address	1-3-2, Wakinohama-Kaigandori, Chuoku, Kobe, Hyogo, 651-0073, JAPAN
TEL	078-200-3010
Homepage URL
Email	kameoka@j-hits.org

Sponsor
Institute	Hyogo Earthquake Memorial 21th Century Research Institute
Institute
Department

Funding Source
Organization	Osaka Kyoiku University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hyogo Institute for Traumatic Stress Ethics Review Committee
Address	1-3-2, Wakinohama-Kaigandori, Chuoku, Kobe, Hyogo, 651-0073, JAPAN
Tel	078-200-3010
Email	tomoko_kobayashi@j-hits.org

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 07 Month 31 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	2021 Year 12 Month 19 Day
Date of IRB	2022 Year 07 Month 13 Day
Anticipated trial start date	2022 Year 07 Month 31 Day
Last follow-up date	2027 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 07 Month 14 Day
Last modified on	2022 Year 07 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055135