UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055702 |
|---|---|
| Receipt number | R000063649 |
| Scientific Title | Parent-Child Interaction Therapy for children |
| Date of disclosure of the study information | 2024/10/02 |
| Last modified on | 2024/10/02 11:50:42 |
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Basic information
Public title
Research on the Effectiveness of Behavioral Therapy Focused on Family and Child Interaction
Acronym
Study on Behavioral Therapy for Family and Child Interaction
Scientific Title
Parent-Child Interaction Therapy for children
Scientific Title:Acronym
PCIT-C Study
Region
| Japan |
Condition
Condition
Toddlers Born Prematurely
Classification by specialty
| Medicine in general | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this pilot study was to examine the feasibility and effectiveness of Parent-Child Interaction
Therapy for Toddlers (PCIT-T) in children under 24 months of corrected age who were born prematurely and had behavioral problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mother-child dyads with children born at less than 37 weeks of gestation and who were under 24 months of corrected age were assigned to the PCIT-T group or the non-PCIT-T group based on maternal desire for treatment. The Eyberg Child Behavior Inventory (ECBI) Intensity score, ECBI Problem score were compared before and after intervention.
Key secondary outcomes
The total Parenting Stress Index Short Form (PSI-SF) score were compared before and after intervention.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Participants were required to meet the following inclusion criteria: the children had to have been born at less than 37 weeks of gestation, the corrected age of children had to be less than 24 months when they were enrolled, the mothers had to perceive their child's behavior as a problem, and families had to use Japanese in daily conversation.
Key exclusion criteria
Children with neurological
disorders requiring medical treatment such as anticonvulsant and antiepileptic are excluded.
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Yukifumi |
| Middle name | |
| Last name | Monden |
Organization
Jichi Medical University
Division name
Department of pediatrics
Zip code
3290413
Address
6-7-7 Higashi
TEL
09018151563
mon4441977319@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yukifumi |
| Middle name | |
| Last name | Monden Yukifumi |
Organization
Jichi Medical University
Division name
Department of Pediatrics
Zip code
3290413
Address
Shimotsuke-city
TEL
09018151563
Homepage URL
mon4441977319@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical Univesity
Institute
Department
Personal name
Funding Source
Organization
JIdhi Medical Univesity
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
Clinical Research Center, Jichi Medical University Hospital
Address
3311-1 Yakushiji, Shimotsuke City, Tochigi Prefecture
Tel
0285-44-2111
jichi@esct.bvits.com
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
| 2024 | Year | 10 | Month | 02 | 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
13
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 01 | Day |
Other
Other related information
In the PCIT-T group, the mean ECBI Intensity score was 137.2 at the baseline assessment and 87.4 at the post-assessment. The mean ECBI Problem score was 12.8 at the baseline assessment and 4.2 at the post-assessment. The mean total PSI-SF score was 57.2 at the baseline assessment and 45.6 at the post-assessment (ECBI Intensity score: p = .001, d = 4.66; ECBI Problem score: p = .006, d = 1.98; total PSI-SF score: p = .042, d = 1.11). Conversely, in the non-PCIT-T group, no scores changed significantly
Management information
Registered date
| 2024 | Year | 10 | Month | 02 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063649
