UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035652 |
|---|---|
| Receipt number | R000040610 |
| Scientific Title | Effect of Language Educational Intervention on Social participation among Emerging Adults with Autism |
| Date of disclosure of the study information | 2019/01/24 |
| Last modified on | 2019/01/23 23:31:05 |
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Basic information
Public title
Effect of Language Educational Intervention on Social participation among Emerging Adults with Autism
Acronym
Effect of Language Educational Intervention
Scientific Title
Effect of Language Educational Intervention on Social participation among Emerging Adults with Autism
Scientific Title:Acronym
Effect of Language Educational Intervention
Region
| Africa |
Condition
Condition
Clinical Condition
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study was to examine the effect of Language Education Intervention (LEI) on social participation among emerging adults with autism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Results indicated a significantly increase in social participation of emerging adults exposed to the LEI when compared to their counterpart in the waitlist control group
Key secondary outcomes
N/A
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Language Education Intervention for increased social participation among emerging adults with autism
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
| 24 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We ensured that every participant met DSM-IV-TR criteria for autism and have low social participation when measured with Social Participation Questionnaire (SPQ). Other criteria included being willing to sign informed consent form be available to attend all the sessions of the intervention, and also have English Language as major communication language.
Key exclusion criteria
Not meeting the inclusion criteria
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Amuche Nnamani |
Organization
Department of Arts Education, University of Nigeria, Nsukka
Division name
Ethics Unit
Zip code
Address
Department of Art Education
TEL
08035458263
Amuche.nnamani@unn.edu.ng
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mkpoikanke Sunday Otu |
Organization
University of Nigeria, Nsukka
Division name
Research Department
Zip code
Address
Department of Educational Foundations, University of Nigeria, Nsukka
TEL
+2348035599525
Homepage URL
mkpoikanke.otu@unn.educ.ng
Sponsor or person
Institute
N/A
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Nigeria
Other related organizations
Co-sponsor
N/A
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 24 | 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 indicated a significantly increase in social participation of emerging adults exposed to the LEI when compared to their counterpart in the waitlist control group
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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 08 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 15 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2019 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040610
