UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047546 |
|---|---|
| Receipt number | R000054200 |
| Scientific Title | The Effect of the Amount of Knowledge of Developmental Disabilities on the Relationship between Individuals with Developmental Disabilities and Their Families: An Examination of e-Learning for Individuals Diagnosed with Developmental Disabilities after Adolescence and Their Families and Others |
| Date of disclosure of the study information | 2022/04/30 |
| Last modified on | 2025/04/22 17:12:04 |
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Basic information
Public title
The Effect of the Amount of Knowledge of Developmental Disabilities on the Relationship between Individuals with Developmental Disabilities and Their Families: An Examination of e-Learning for Individuals Diagnosed with Developmental Disabilities after Adolescence and Their Families and Others
Acronym
The Effect of the Amount of Knowledge of Developmental Disabilities on the Relationship between Individuals with Developmental Disabilities and Their Families
Scientific Title
The Effect of the Amount of Knowledge of Developmental Disabilities on the Relationship between Individuals with Developmental Disabilities and Their Families: An Examination of e-Learning for Individuals Diagnosed with Developmental Disabilities after Adolescence and Their Families and Others
Scientific Title:Acronym
The Effect of the Amount of Knowledge of Developmental Disabilities on the Relationship between Individuals with Developmental Disabilities and Their Families
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Increase the amount of knowledge about developmental disabilities to change family relationships and improve quality of life
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10 questions confirming knowledge of developmental disabilities .
Just before and after the e-Learning viewing.
Assessed one month after viewing
Evaluate the effectiveness of e-Learning viewing by the percentage of questions answered correctly
Key secondary outcomes
GHQ12: Mental Health Survey Question. Consisting 12 questions.
DDPSI(Yamane 2013)18 questions: Stressor Scale for Parents of Children with Developmental Disabilities. Consisting 18 questions.
WHO SUBI: Self-assessment of mental health 40 questions Subjective well-being - Social support Relationships with family and others Consisting 40 questions.
BMPS(Jones et al., 2014): Bangor Mindful Parenting Scale. Consisting 15 questions.
Semi-structured interview with category analysis by modified M-GTA (Kinoshita 2003)
Evaluated using each scale immediately before and one month after viewing the e-Learning.
Mental health, stress status, quality of life, etc. are evaluated based on the evaluation criteria of each scale.
Semi-structured interviews will be conducted only one month after the e-Learning viewing to evaluate changes in family relationships through qualitative analysis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Ten subjects will receive the intervention for approximately one month.
The subjects will begin viewing the e-Learning immediately after the initial assessment of knowledge questions.
During the one-month period, subjects will be free to watch the e-Learning.
The number of times and frequency of e-Learning sessions are arbitrary.
One month after the start of viewing, the subjects will be evaluated again based on their knowledge.
In addition, an interview survey will be conducted.
Interventions/Control_2
25 subjects will receive the intervention for approximately one month
Initial assessment with knowledge questions, etc.
Immediately afterwards, viewing of the e-Learning program begins.
During the one-month period, subjects are free to watch e-Learning
The number of times and frequency are arbitrary.
One month after the start of viewing, the participants will be evaluated again based on their knowledge.
Interventions/Control_3
25 subjects, approximately 2 months of intervention.
Initial assessment with knowledge questions, etc.
One month later, the same evaluation is conducted.
After that, start watching e-Learning
Subjects are free to watch e-Learning during the one-month period
The number of sessions and frequency are arbitrary.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study population will consist of close family members or partners of the person concerned who was diagnosed with a developmental disability at the time of the diagnosis or suspected diagnosis after the age of 10 and who are 20 years of age or older and healthy.
Key exclusion criteria
Persons with serious mental illness or rarefied thoughts of death
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Kanazawa University
Division name
School of Teacher Education, College of Human and Social Sciences
Zip code
920-1192
Address
Kakuma machi, Kanazawa, Ishikawa
TEL
076-254-5513
kobah@ed.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Kanazawa University
Division name
School of Teacher Education, College of Human and Social Sciences
Zip code
920-1192
Address
Kakuma machi, Kanazawa, Ishikawa
TEL
076-254-5513
Homepage URL
kobah@ed.kanazawa-u.ac.jp
Sponsor or person
Institute
Research Center for Child Mental Development,
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Kanazawa University
Address
13 Takaramachi, Kanazawa, Ishikawa
Tel
076-265-2110
rinri@adm.kanazawa-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 30 | 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 | 04 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054200
