UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Language Educational Intervention on Social participation among Emerging Adults with Autism
Title of the study (Brief title)	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	Amuche Nnamani
Organization	Department of Arts Education, University of Nigeria, Nsukka
Division name	Ethics Unit
Address	Department of Art Education
TEL	08035458263
Email	Amuche.nnamani@unn.edu.ng

Public contact
Name of contact person	Mkpoikanke Sunday Otu
Organization	University of Nigeria, Nsukka
Division name	Research Department
Address	Department of Educational Foundations, University of Nigeria, Nsukka
TEL	+2348035599525
Homepage URL
Email	mkpoikanke.otu@unn.educ.ng

Sponsor
Institute	N/A
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040610