UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062225 |
|---|---|
| Receipt number | R000070390 |
| Scientific Title | A Feasibility Study of an On-Demand Psychoeducational Program for Caregivers of Adolescents with Neurodevelopmental Disorders |
| Date of disclosure of the study information | 2026/07/13 |
| Last modified on | 2026/07/13 20:58:46 |
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Basic information
Public title
Feasibility Study of an Online Psychoeducation Program for Parents of Adolescents with Neurodevelopmental Disorders
Acronym
A Psychoeducational Program for Parents of Children with Neurodevelopmental Conditions
Scientific Title
A Feasibility Study of an On-Demand Psychoeducational Program for Caregivers of Adolescents with Neurodevelopmental Disorders
Scientific Title:Acronym
Pilot Study of a Psychoeducational Program for Parents of Children with Neurodevelopmental Disorders
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder or Attention-Deficit/Hyperactivity Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to pilot an on-demand psychoeducational program comprising web-based psychoeducational videos incorporating elements of CBT and CFT for caregivers of adolescents with neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder, and to evaluate its feasibility and acceptability.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dropout rate and session completion rate, defined as the proportion of completed video views
Key secondary outcomes
the proportion of applicants who are enrolled in the study, the completion rate of assignments provided alongside the videos, questionnaires on satisfaction and understanding, the Parenting Sense of Competence Scale (PSOC), the Strengths and Difficulties Questionnaire (SDQ), and the Perceived Stress Scale (PSS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study targets caregivers, rather than children with diagnosed neurodevelopmental disorders (NDDs) who are receiving care at medical institutions. All samples and information collected in this study will be provided by the caregivers.
At the time of application, only the following information will be collected: telephone number, email address, whether the child has been diagnosed with autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD), and responses to the questionnaires used for screening.
For applicants who meet the eligibility criteria and are enrolled in the study, background information including the caregiver's sex and age, as well as the sex and age of the target child, will be collected.
Thereafter, participants will complete psychological scales and other questionnaires using Google Forms at three time points: before the intervention (video viewing) begins (Pre), at the end of the intervention period (Post), and two weeks after the end of the intervention period (Follow-up).
During the study period, information sharing with participants, including communication, guidance, and handling inquiries, will be conducted through a study-specific LINE group.
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
| 29 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Caregivers of children aged 11-17 years who have been diagnosed with autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD)
Individuals who have internet access at home and are able to use the LINE app and view on-demand videos
Individuals who, after receiving a sufficient explanation about participation in this study and fully understanding its contents, provide written informed consent of their own free will
Key exclusion criteria
Individuals who are currently receiving treatment for a psychiatric disorder
This refers to cases in which the participating caregiver is currently receiving treatment for a psychiatric disorder.
Individuals whose child in the eligible age range does not have a diagnosis of autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD)
This includes cases in which the child is suspected of having ASD or ADHD but has not received a diagnosis, or cases in which the caregiver has a child aged 11-17 years, but the diagnosed child is a sibling outside the eligible age range.
Individuals whose child has a diagnosis of ASD or ADHD but does not meet the cutoff scores on the screening questionnaires described below
Individuals from whom consent cannot be obtained
Individuals whom the principal investigator otherwise judges to be unsuitable for participation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Taguchi |
Organization
Chiba University
Division name
Research Center for Child Mental Development
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-226-2027
k.taguchi@chiba-u.jp
Public contact
Name of contact person
| 1st name | Akari |
| Middle name | |
| Last name | Matsuzawa |
Organization
Chiba University
Division name
Cognitive Behavioral Physiology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL
043-226-2027
Homepage URL
recruit5@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT) / Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee of the Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel
043 -226 -2027
inohana-rinri@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 | 07 | Month | 13 | 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
| 2026 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2026 | Year | 07 | Month | 13 | Day |
Last modified on
| 2026 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070390
