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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name