UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048375 |
|---|---|
| Receipt number | R000055135 |
| 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 |
| Date of disclosure of the study information | 2022/07/31 |
| Last modified on | 2022/07/14 17:01:12 |
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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
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
kameoka@j-hits.org
Sponsor or person
Institute
Hyogo Earthquake Memorial 21th Century Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055135
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
