UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059508 |
|---|---|
| Receipt number | R000068068 |
| Scientific Title | A Non-Randomized Comparative Study on the Effectiveness of the Circle of Security Parenting (COSP) Program for Caregivers and Children with Neurodevelopmental Disorders |
| Date of disclosure of the study information | 2025/10/22 |
| Last modified on | 2025/10/22 22:51:15 |
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Basic information
Public title
Effectiveness Study of the Circle of Security Parenting (COSP) Program for Children with Neurodevelopmental Disorders and Their Caregivers
Acronym
Effectiveness Study of the Circle of Security Parenting (COSP) Program for Children with Neurodevelopmental Disorders and Their Caregivers
Scientific Title
A Non-Randomized Comparative Study on the Effectiveness of the Circle of Security Parenting (COSP) Program for Caregivers and Children with Neurodevelopmental Disorders
Scientific Title:Acronym
A Non-Randomized Comparative Study on the Effectiveness of the Circle of Security Parenting (COSP) Program for Caregivers and Children with Neurodevelopmental Disorders
Region
| Japan |
Condition
Condition
Neurodevelopmental Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will implement the Circle of Security Parenting (COSP) program for caregivers of children with neurodevelopmental disorders and evaluate over a six-month observation period, changes in children's behavioral problems and improvements in parental responsiveness, parenting self-efficacy, and parenting stress levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tool to Measure Parenting Self-Efficacy Japanese version (TOPSE)
Child Behavior Checklist 4-18 (CBCL)
Coping with Toddlers' Negative Emotions Scale (CTNES) for the parental response to child distress
Parenting Stress Index (PSI)
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will participate in the eight-session Circle of Security Parenting (COSP) program, with each session lasting approximately 120 minutes and conducted on a weekly basis.
Interventions/Control_2
No treatment
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children (Intervention/Non-Intervention Groups)
1. Children with a primary diagnosis of a neurodevelopmental disorder
2. Aged between 6 and 12 years at the time of study participation
3. Receiving outpatient care at a medical institution
Caregivers (Intervention Group)
1. Able to participate in all eight COSP sessions
2. Provided written informed consent after receiving a full explanation of the study and demonstrating sufficient understanding of its content, based on their own free will.
Caregivers (Non-Intervention Group)
1. Caregivers of children aged 6-12 years with a primary diagnosis of a neurodevelopmental disorder
2. Received a written invitation describing the study objectives, procedures, potential benefits and risks, contact information, and ethical considerations, and agreed to participate by returning a signed consent form.
Key exclusion criteria
Children
1) Receiving 90 min total or more per week of intensive intervention therapy or psychotherapy, or if they began or changed a pharmacotherapeutic regimen during the study period.
Caregivers
1) Caregivers with a mental illness or developmental disability, or who had been reported to the juvenile welfare officer for perpetrating severe child abuse.
2) Previous or ongoing participation in a COSP-based psychological program at the time of study enrollment.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Nobuyo |
| Middle name | |
| Last name | KUBO |
Organization
Kansai University of Welfare Sciences
Division name
School of Psychological Science
Zip code
582-0026
Address
3-11-1 Asahigaoka, Kashiwara-shi, Osaka
TEL
072-978-0088
kubo@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyo |
| Middle name | |
| Last name | KUBO |
Organization
Kansai University of Welfare Sciences
Division name
School of Psychological Science
Zip code
582-0026
Address
3-11-1 Asahigaoka, Kashiwara-shi, Osaka
TEL
072-978-0088
Homepage URL
kubo@tamateyama.ac.jp
Sponsor or person
Institute
Kansai University of Welfare Sciences
Institute
Department
Personal name
Funding Source
Organization
Kansai University of Welfare Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Heartland Shigisan Children's Mental Health Center, Shigisan Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai University of Welfare Sciences, Ethics Committee
Address
3-11-1 Asahigaoka, Kashiwara-shi, Osaka
Tel
072-978-0088
kenkyu-shien@tamateyama.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
関西福祉科学大学（大阪府）Kansai University of Welfare Sciences
一般社団法人信貴山病院ハートランドしぎさんこどものこころ診療センター（奈良県）Heartland Shigisan Children’s Mental Health Center, Shigisan Hospital
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 22 | 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
| 2025 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 10 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068068
