UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063562 |
|---|---|
| Receipt number | R000071601 |
| Scientific Title | Development and Feasibility Evaluation of a Compassion Focused Therapy Based Parent Child Program for Adolescents and Young Adults with Neurodevelopmental Disorders and Their Parents A Pilot Feasibility Study |
| Date of disclosure of the study information | 2026/11/08 |
| Last modified on | 2026/11/08 23:55:52 |
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Basic information
Public title
Development and Feasibility Evaluation of a Compassion Focused Therapy Based Parent Child Program for Adolescents with Neurodevelopmental Disorders and Their Parents
Acronym
parent-child program "CASA" for Adolescents with neurodevelomental disorder and their parents
Scientific Title
Development and Feasibility Evaluation of a Compassion Focused Therapy Based Parent Child Program for Adolescents and Young Adults with Neurodevelopmental Disorders and Their Parents
A Pilot Feasibility Study
Scientific Title:Acronym
NDD,CFT Parent,Child Pilot Study
Region
| Japan |
Condition
Condition
Neurodevelopmental Disorder, Autism Spectrum Disorder,ASD Attention Deficit Hyperactivity Disorder, ADHD
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility and acceptability of a Compassion Focused Therapy based parent child program for adolescents and young adults with neurodevelopmental disorders and their parents. The study also aims to exploratively evaluate changes in psychological outcomes from baseline to post-intervention and follow-up to assess preliminary signals of intervention efficacy.
Basic objectives2
Others
Basic objectives -Others
Feasibility, acceptability, and exploratory efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self Compassion Scale for Youth score, assessed at baseline, week 0, post-intervention week 8, and 1 month follow up. The primary evaluation will examine the change from baseline to post intervention
Key secondary outcomes
Children:
Self report Strengths and Difficulties Questionnaire, General Self Efficacy Scale for Children
Parents:
Japanese version of the Self-Compassion Scale, Parent-report Strengths and Difficulties Questionnaire, General Self Efficacy Scale, Parenting Resilience Elements Questionnaire
These outcomes will be assessed at baseline ,week 0, post-intervention,week 8, and 1 month follow up.
In addition, semi structured interviews with parents and children will be conducted within one week after completion of the program to explore feasibility and acceptability, including perceived duration, comprehensibility, usefulness, and perceived benefits of the program.
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A Compassion Focused Therapy based parent child program will be provided to adolescents and young adults with neurodevelopmental disorders and their parents. The program will consist of eight sessions of approximately 50 minutes each. Sessions will generally be conducted online. Based on the principles of CFT, the program will include psychoeducation on compassion, awareness of self criticism, and exercises to cultivate a compassionate mind.
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
| 13 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals who meet the DSM-5 diagnostic criteria for a neurodevelopmental disorder.
2.Children aged 13 to 24 years at the time of consent and their parents. There is no age restriction for parents.
3.Individuals who have obtained permission to participate from their attending physician.
4.Individuals with sufficient language ability to participate in the program.
5.Individuals who have received sufficient explanation of the study, fully understood it, and provided written informed consent voluntarily.
6.Individuals experiencing difficulties related to the child's maladaptive behaviors at home, school,including school non-attendance, or other settings.
7.For online participation, individuals who have internet access at home and are able to participate continuously in the online intervention.
Key exclusion criteria
1.Individuals with a severe mental disorder, such as a psychotic disorder, bipolar disorder, or substance-related disorder according to DSM-5, for whom discontinuation of the study is 2.anticipated due to worsening symptoms.
3.Individuals who do not provide informed consent after receiving and understanding a sufficient explanation of the study, or who refuse the use of their information for research purposes.
4.Individuals with a serious progressive physical illness for whom discontinuation of the study is anticipated.
5.Individuals judged by the principal investigator or study psychologist to be unsuitable for safe participation in the study.
6.Individuals receiving other active treatments, such as cognitive behavioral therapy, during the study period.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University
Division name
Research Centre for Child Mental Development
Zip code
260-8670
Address
1-8-1 inohana Chuoku Chiba city
TEL
8143-226-2027
k.taguchi@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University
Division name
Research Center forf Child Mental Development,
Zip code
260-8670
Address
1-8-1 inohana Chuoku Chiba city
TEL
0432262027
Homepage URL
k.taguchi@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Promotion Section, Chiba University School of Medicine
Address
1-8-1 inohana chuoku Chiba city
Tel
043-226-2462
igaku-rinri@office.chiba-u.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
| 2026 | Year | 11 | Month | 08 | 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
| 2025 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 08 | Day |
Last modified on
| 2026 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071601
