UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005195
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email tatibana@idac.tohoku.ac.jp

Sponsor
Institute IDAC, Tohoku University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.