UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043521 |
|---|---|
| Receipt number | R000049700 |
| Scientific Title | A randomized controlled trial of the Circle of Security Parenting program |
| Date of disclosure of the study information | 2021/03/04 |
| Last modified on | 2024/03/08 16:01:57 |
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Basic information
Public title
Intervention effects of the Circle of Security Parenting program
Acronym
Intervention effects of the Circle of Security Parenting program
Scientific Title
A randomized controlled trial of the Circle of Security Parenting program
Scientific Title:Acronym
A randomized controlled trial of the Circle of Security Parenting program
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) We will examine the intervention effects of COSP on improving child attachment and parental responsiveness in an RCT.
(2) We will examine the maintenance of intervention effects and the delayed effects with a 6-month follow-up assessment only for the intervention group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Strange Situation Procedure (SSP) for child attachment and Coping with Toddlers' Negative Emotions Scale (CTNES) for the parental response to child distress will be used at the baseline and after COSP. The intervention group will be assessed with SSP and CTNES at follow-up assessment 6-month later.
Key secondary outcomes
Attachment Script Assessment (ASA), Child Behavior Checklist (CBCL), Experience in Close Relationship scale (ECR), Center for Epidemiological Studies Depression Scale (CES-D), and Emotional Availability (EA) will be used at the baseline and after COSP, and they will be used for the intervention group at follow-up assessment 6-month later.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group parents will attend weekly 90-min COSP group meetings for 8 weeks.
Interventions/Control_2
The control group is placed on a waiting list.
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
| 1 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The parent is over the age of 18, proficient in Japanese and available for weekly group intervention meetings.
The child is from 1 year and up to 5 years old.
Key exclusion criteria
The Parent does not have untreated severe mental disorders, is not a previous COSP participant, and has not received COSP training in the past. The child has no severe illness or major developmental disorders.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Kitagawa |
Organization
Konan University
Division name
Faculty of Letters
Zip code
658-8501
Address
8-9-1 Okamoto Higashinada-ku, Kobe, JAPAN
TEL
078-431-4341
kitagawa@konan-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Kitagawa |
Organization
Konan University
Division name
Faculty of Letters
Zip code
658-8501
Address
8-9-1 Okamoto Higashinada-ku, Kobe, JAPAN
TEL
078-431-4341
Homepage URL
kitagawa@konan-u.ac.jp
Sponsor or person
Institute
Konan University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Univ. of Tsukuba
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Konan University, Ethical Review Committee for Research Involving Human Subjects
Address
8-9-1 Okamoto Higashinada-ku, Kobe, JAPAN
Tel
078-431-4341
o-president@adm.konan-u.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
甲南大学（兵庫県）、筑波大学東京キャンパス（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 04 | 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
| 2018 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 05 | 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
| 2021 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049700
| 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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