UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048178 |
|---|---|
| Receipt number | R000054896 |
| Scientific Title | Intervention effect study for staff in charge of children with developmental disorders |
| Date of disclosure of the study information | 2022/06/27 |
| Last modified on | 2025/02/28 09:24:39 |
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Basic information
Public title
Development of staff skill improvement program at child development support office
Acronym
Development of staff skill improvement program at child development support office
Scientific Title
Intervention effect study for staff in charge of children with developmental disorders
Scientific Title:Acronym
Intervention effect study for staff in charge of children with developmental disorders
Region
| Japan |
Condition
Condition
developmental disorders
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate whether taking teacher training will change the following: Changes in child behavior and relationships with staff in child development support establishments, changes in staff support styles and daily work, and changes in children's behavior at home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sutter-Eyberg Stuent Behavior Inventory-Revised,
Eyberg Child Behavior Inventory
Key secondary outcomes
Canadian Occupational Performance Measure,
Student Teacher Relationship Scale,
Parental Child Rearing Scale,
Record of target children by the staff,
What the staff said at the conference
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 period for the implementation group is about 12 weeks, and all 7 sessions are conducted every other week for about 1 hour.
Interventions/Control_2
No teacher training is given to the control group
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
| 3 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
target child: children using the child development support offices, children with the consent of their parents
Target person: staff in charge of the target child, staff who got consent
Key exclusion criteria
target child: children who are expected to be mentally burdened by being subject to questionnaires and home work, children who do not get consent from their parents
target person: those who are expected to be mentally burdened by carrying out the homework that is imposed every time they participate in teacher training and reporting the homework in front of others, those who are expected to be mentally tired to answer the questionnaire
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Haruka |
| Middle name | Toeda |
| Last name | Umemoto |
Organization
Gunma University
Division name
Graduate School of Health Sciences Department
Zip code
371-8514
Address
3-39-22 Syowa-machi, Maebashi-City
TEL
0272208953
to.haruka@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | Toeda |
| Last name | Umemoto |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Syowa-machi, Maebashi-City
TEL
0272208953
Homepage URL
to.haruka@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Medical Research Ethics Review Committee for Humans
Address
3-39-15 Syowa-machi, Maebashi-City
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
群馬大学，株式会社ワンライフ 児童発達支援事業所chuouchou
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
48
Results
The most common behaviors were "hyperactivity," "inattention," and "communication," but the behaviors that staff found particularly difficult were "self-harm," "harm to others," "panic," and "self-centered behavior."Responses to "self-harm" and "harm to others" were diverse, including "trying to stop the child on the spot," while half of the responses to "panic" and "self-centered behavior" were "allowing the child to cool down," showing that this is a relatively well-established approach.
Results date posted
| 2025 | Year | 01 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
non-medical staff working at child development support centers
Participant flow
The method involved the researchers visiting 11 child development support business locations in Gunma Prefecture where prior consent had been obtained, and explaining the outline of the study verbally and in writing to the head of the facility. If consent was obtained, the head of the facility would then explain the study to the subjects, or the researchers would explain the study verbally and in writing to the subjects directly, and subjects who agreed were asked to fill out a questionnaire. The response deadline was 1-2 weeks, and subjects were asked to submit their responses in collection boxes set up within the facility (a hold survey).
Adverse events
none
Outcome measures
1. Do your children exhibit these behaviors? 2. If so, how much difficulty do you have in dealing with this behavior? (Answer on a 10-point scale from 1 to 10) 3. How do you deal with this behavior?
1. Difficulty sustaining concentration
2. Easily distracted
3. Difficulty listening to others
4. Difficulty responding to general instructions
5. Cannot respond to individual verbal instructions
6. Difficulty participating in group activities
7. Not participating in morning meetings or end-of-day meetings
8. Leaving the seat when sitting down to do tasks
9. Leaving the room when sitting down to do tasks
10. Restless behavior
11. Violence towards other children (hitting, kicking, etc.)
12. Verbal abuse towards other children
13. Does not play with friends (only shares the same space, plays different games from the others)
14. Cannot play while interacting with friends
15. Does not join in with children of the same age (cannot invite friends to play)
16. Does not like playing with friends
17. Often plays alone
18. Cannot understand the rules of the game
19. Does not look in the direction pointed at
20. Does not come when called by name
21. Does not respond when spoken to
22. Does not respond when other children ask for "give it back"
23. Difficulty expressing one's intentions in ways other than words (nodding, facial expressions)
24. Slower speech than children of the same age
25. Cannot express intentions verbally when disliked
26. Cannot express intentions verbally when needed
27. Difficulty asking for help verbally when in trouble
28. Rarely looks at other people's faces when speaking
29. Takes time to get used to new situations and places
30. Sometimes hides friends' things
31. Wakes up sleeping children during naptime
32. Acts self-centeredly
33. Goes at his own pace
34. Sulks when things do not go his way
35. Panics when things do not go his way
36. Self-harms (e.g. biting one's arm, etc.)
37. Picky eaters
38. Eats slowly
39. Eating without chewing properly
40. Having sensory hypersensitivity (e.g. covering ears, not participating in playing in sand or mud, etc.)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2022 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054896
