UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049623 |
|---|---|
| Receipt number | R000056182 |
| Scientific Title | Factors associated with treatment responsiveness and treatment course of Parent-Child Interaction Therapy (PCIT) |
| Date of disclosure of the study information | 2022/11/30 |
| Last modified on | 2024/08/08 16:35:01 |
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Basic information
Public title
Factors associated with treatment responsiveness and treatment course of Parent-Child Interaction Therapy (PCIT)
Acronym
Factors associated with treatment responsiveness and treatment course of Parent-Child Interaction Therapy (PCIT)
Scientific Title
Factors associated with treatment responsiveness and treatment course of Parent-Child Interaction Therapy (PCIT)
Scientific Title:Acronym
Factors associated with treatment responsiveness and treatment course of Parent-Child Interaction Therapy (PCIT)
Region
| Japan |
Condition
Condition
Caregiver and Child aged between 2-7 years old who displays disruptive behaviors (e.g., conduct disorder, ADHD, ASD, separation anxiety disorder, maltreatment etc)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
While PCIT exhibits high efficacy, its attrition is very high. One possible factor behind this attrition rate is the difference in the treatment responsiveness between the treatment completers and dropouts. As the psychosocial background situation of the dyads may have influence on the treatment responsiveness, the current study utilizes questionnaires used in regular clinical PCIT treatment, as well as the questionnaires to assess psychosocial backgrounds, to explore the dyads' treatment responsiveness and the difference in the background factors.
Basic objectives2
Others
Basic objectives -Others
Exploring the caregiver and child dyad's treatment responsiveness and the difference in their background factors (e.g., psychosocial factors)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment responsiveness, including treatment attrition
Key secondary outcomes
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
| Other |
Interventions/Control_1
Conduct Parent-child Interaction Therapy once a week until dyads complete (or dropout) the treatment
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
| 2 | years-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Caregivers and children between the ages of 2 and 7 years old at the time of consent
2) Caregivers and children who are experiencing behavioral problems, parenting difficulties, or difficulties in relating to their children.
3) Those who have given their consent through an outpatient program or through public solicitation via the website.
4) Caregivers and children for whom PCIT is appropriate based on the clinical judgment of a physician.
Key exclusion criteria
1) When medical care other than PCIT is desired by the physician
2) When the child's caregiver has Intellectual Disability.
3) When there is a significant child abuse and immediate social welfare support is desired.
4) Other cases in which the principal investigator deems it difficult to perform the examination
5) Other cases in which the principal investigator determines that PCIT is inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Egashira |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Developmental Disorders, National Institute of Mental Health
Zip code
1878553
Address
4-1-1 Ogawahigashi, Kodaira-shi, Tokyo, Japan
TEL
+81-42-346-2157
yu-kaegashira@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Takada |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Developmental Disorders, National Institute of Mental Health
Zip code
1878553
Address
4-1-1 Ogawahigashi, Kodaira-shi, Tokyo, Japan
TEL
+81-42-341-2712-6276
Homepage URL
https://www.ncnp.go.jp/nimh/chiteki/news/pcit
mtakada@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawahigashi, Kodaira-shi, Tokyo, Japan, 1878553
Tel
+81-42-341-2712
rinri-jimu@ncnp.go.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
| 2022 | Year | 11 | Month | 30 | 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
| 2022 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 10 | 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 | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056182
