UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005195 |
|---|---|
| Receipt number | R000006169 |
| Scientific Title | An intervention study of cognitive rehabilitation for children with developmental disorders by reading aloud |
| Date of disclosure of the study information | 2011/03/05 |
| Last modified on | 2011/03/24 02:07:56 |
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Basic information
Public title
An intervention study of cognitive rehabilitation for children with developmental disorders by reading aloud
Acronym
Reading aloud program for children with developmental disorders
Scientific Title
An intervention study of cognitive rehabilitation for children with developmental disorders by reading aloud
Scientific Title:Acronym
Reading aloud program for children with developmental disorders
Region
| Japan |
Condition
Condition
Learning disabilities
Classification by specialty
| Pediatrics | Psychiatry | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effectiveness of "reading aloud", which activate frontal lobe function, for children with learning disabilities
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Wisconsin Card Sorting Test
Key secondary outcomes
Stroop Task, Spanboard task (WAIS-RNI), Digit span (WISC-3), Raven Colored Matrix, Child Behavior Check List
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Reading books aloud for 30 miniutes five times a week for 6 weeks
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
| 8 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) diagnosis of pervasive developmental disorder
(2) age between 7 and 12 years at inclusion
Key exclusion criteria
1. being treated with stimulants, atomoxetine, neuroleptic, or any
other psychoactive drugs
2. IQ <80 (based on WISC-3)
3. fulfilling criteria for diagnosis of clinically
significant attention deficit hyperactive disoreder, oppositional defiant disorder or depression
4. history of seizures during
the past 2 years
5. educational level and socioeconomic situation that made it unlikely that the family would be able to follow the treatment procedure and study requirements (the educational level of the parents was not specified in terms of academic degree); and
6. medical illness requiring immediate treatment.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Kawashima |
Organization
IDAC, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
4-1 Seiryou-machi, Aoba-ku, Sendai-shi, Miyagi-ken, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
IDAC, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
TEL
Homepage URL
tatibana@idac.tohoku.ac.jp
Sponsor or person
Institute
IDAC, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
A Strategic Research and Education Center for an Integrated Approach to Language and Cognition (Tohoku University)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北福祉大学
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 05 | Day |
Last modified on
| 2011 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006169
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
