UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050006 |
|---|---|
| Receipt number | R000056961 |
| Scientific Title | Effects of the Child-Adult Relationship Enhancement (CARE) Program for Caregivers of 2-Year-Olds to 6th-Grade Students in Community Health Sector - A Randomized Controlled Trial - |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2023/01/10 22:47:04 |
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Basic information
Public title
Effects of the Child-Adult Relationship Enhancement (CARE) Program for Caregivers of 2-Year-Olds to 6th-Grade Students in Community Health Sector - A Randomized Controlled Trial -
Acronym
Effects of CARE for Caregivers in Community Health - A Randomized Controlled Trial -
Scientific Title
Effects of the Child-Adult Relationship Enhancement (CARE) Program for Caregivers of 2-Year-Olds to 6th-Grade Students in Community Health Sector - A Randomized Controlled Trial -
Scientific Title:Acronym
Effects of CARE for Caregivers in Community Health - A Randomized Controlled Trial -
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the effects of CARE conducted on Japanese mothers having children aged 2 years old to 6th grade in community health and examined the cognition of caregivers childcare and changes in parenting behavior (improvement of parenting skills, reduction of inappropriate childcare, improving recognition of parenting behavior/relationships, and increased acceptance of child-rearing) and changes in children (reduction of child's problematic behavior evaluated by mothers).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in caregivers' cognition of child-rearing and changes in child-rearing behavior (improvement of child-rearing skills, reduction of inappropriate child-rearing, improvement of cognition of child-rearing behavior and relationships, increased acceptance of child-rearing) and changes in children (mothers' evaluation of children's mitigation of problem behavior)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
CARE: Child-Adult Relationship Enhancement (Robin H. G., 2016) is an intervention program that focuses on improving the parent-child relationship and strengthening the bond between parents and their children. It was created based on psychotherapies such as PCIT: Parent-Child Interaction Therapy (Eyberg, 1988), which has been shown to be effective in reducing problem behaviors in children overseas. CARE for parents and other caregivers is a program that can be implemented for a group of people, which can be learned in a 3-6 hour workshop. In this study, participants attended the CARE program (two 2-hour sessions for a total of 4 hours) and a follow-up program (one 2-hour session: Prosocial) and learned The program is to be implemented in the families of the caregivers to practice what they learned with their children.
Interventions/Control_2
no intervention
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
| 18 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person who meets all of the following criteria.
(1) If the applicant agrees to participate in the CARE program (including pre- and post-surveys)
(2) Able to communicate adequately in Japanese and have no difficulty in decision-making
(3) Be between 18 and 64 years of age and give written consent
(4) If this is the first time participating in a CARE program (not including lectures) of more than 3 hours in duration
Key exclusion criteria
Persons who meet at least one of the following criteria
(1)Experienced a serious life event (death of a close relative, serious illness, or other extremely stressful event) within six months of the time of the preliminary survey
(2)If the researcher is deemed ineligible
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | HITOE |
| Middle name | |
| Last name | KIMURA |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of Nursing Department of Nursing
Zip code
814-0001
Address
3-6-40 Momochihama,Sawaraku,Fukuoka
TEL
092-832-1200
kimurahitoe55@s.takagigakuen.ac.jp
Public contact
Name of contact person
| 1st name | HITOE |
| Middle name | |
| Last name | KIMURA |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of Nursing Department of Nursing
Zip code
814-0001
Address
3-6-40 Momochihama,Sawaraku,Fukuoka
TEL
092-832-1200
Homepage URL
kimurahitoe55@s.takagigakuen.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
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
Fukuoka International University of Health and Welfare Research Ethics Review Committee
Address
3-6-40 Momochihama Sawara-ku, Fukuoka-shi, Fukuoka-ken
Tel
092-832-1200
fiuhw-rinri@takagigakuen.ac.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
| 2023 | Year | 01 | Month | 10 | 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 | 08 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | 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
| 2023 | Year | 01 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056961
